Reported trial results for Lung Cancer
Every Lung Cancer trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
156 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT04655976 · results posted 1 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04655976) enrolled 758 people across three groups. Participants in Arm A (305 people) received a combination of three medicines — cobolimab, dostarlimab, and docetaxel. Arm B (301 people) received dostarlimab and docetaxel. Arm C (152 people) received docetaxel alone, serving as the comparison group. The trial was primarily measuring overall survival — that is, how long, on average, participants lived from the time they joined the study. The reported data shows that the median overall survival (the point at which half of participants in a group had died and half had not) was 11.9 months in Arm A and 11.3 months in Arm C. In Arm B, it was 11.8 months, compared again to 11.3 months in Arm C. When Arms A and B were compared directly, the figures were 11.9 months versus 11.8 months respectively. For secondary measures, the reported data shows that the proportion of participants whose tumours shrank to a meaningful degree (called the overall response rate) was 18.7% in Arm A, 18.3% in Arm B, and 14.5% in Arm C. The time until the disease worsened or death occurred (progression-free survival) was reported as 4.4 months, 4.2 months, and 4.1 months for Arms A, B, and C respectively. Among those who did respond to treatment, the length of time that response lasted (duration of response) was reported as 8.3 months in Arm A, 7.1 months in Arm B, and 8.8 months in Arm C. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06145048 · results posted 13 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 89 adults who were scheduled for lung surgery. All 89 participants received a single intravenous (into the vein) dose of an investigational imaging agent called VGT-309, given 12 to 36 hours before their operation. The trial was measuring how often this agent — which is designed to make certain tissue glow under a special near-infrared (NIR) light during surgery — provided information that standard surgical methods alone did not. Eighty-eight participants completed the study, and one did not. The reported data shows that the main outcome — called a "Clinically Significant Event" — occurred in approximately 44.9% of participants (a proportion of 0.449). This means that in roughly 45 out of every 100 people in the trial, the glowing agent appeared to highlight something during surgery that standard methods had not identified on their own, such as a hard-to-find lesion, a close surgical margin (how near the cut edge was to abnormal tissue), or a cancerous lymph node, with all findings confirmed by laboratory tissue examination. For the secondary outcomes, the reported data shows a "positive predictive value" (PPV) of 0.750 — meaning that when tissue did glow, it was confirmed as cancerous by laboratory testing about 75% of the time. The proportion of times tissue glowed but turned out not to be cancerous was reported as 0.250 (25%). The "sensitivity" — meaning how often cancerous tissue that was present actually did glow — was reported as 0.841, or approximately 84%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06380361 · results posted 21 April 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all placed into a single group. The trial was testing a device called the BioSpy System, which takes electrical measurements of tissue during a bronchoscopy (a procedure where a thin tube is passed into the airways to examine the lungs). The main goal was to see whether the device could successfully record these electrical measurements from suspicious tissue areas. Three participants did not complete the trial, leaving 27 who finished. The reported data shows that for the primary goal — successfully obtaining at least one usable electrical measurement from the suspicious tissue — this was achieved in 26 out of 30 participants. For the secondary goals, the trial looked at whether the device's readings, analysed by a computer learning program, could tell the difference between suspicious and healthy tissue. The reported figures for this were: an average accuracy of 80.9%, an average sensitivity (how often the device correctly identified suspicious tissue) of 88.5%, and an average specificity (how often it correctly identified healthy tissue) of 71.4%. The trial also looked at whether the device could specifically identify cancerous tissue compared to other tissue types, reporting an average accuracy of 78.7%, sensitivity of 78.3%, and specificity of 79.2%. It is worth noting that these figures come from a computer model trained and tested on this same small group of 30 patients, which is an important limitation to be aware of when reading these numbers. The reported data describes only what was measured and the numbers produced — it does not on its own tell us how this device would perform more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04222972 · results posted 5 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04222972) enrolled 223 participants across two main treatment groups during the treatment period: 113 people received standard-of-care (SOC) treatment and 110 received a medicine called pralsetinib. A further 38 participants later crossed over to receive pralsetinib in a separate crossover period. The trial was primarily measuring how long participants lived without their cancer growing or spreading — a measure called "progression-free survival" — and also looked at a range of other outcomes including how many participants' tumours shrank, how long those responses lasted, and how long participants survived overall. The reported data shows that, for the main comparison between the two treatment groups, the median time without cancer progression was reported as 9.0 months for the standard-of-care group and 18.7 months for the pralsetinib group. When looking at the proportion of participants whose tumours shrank (the objective response rate), the reported figures were 41.6% for the standard-of-care group and 65.5% for the pralsetinib group. For how long those responses lasted, the reported median duration was 9.7 months in the standard-of-care group and 20.6 months in the pralsetinib group. Regarding overall survival (time from enrolment to death from any cause), the standard-of-care group had a reported median of 39.8 months, while a median figure for the pralsetinib group was not yet able to be calculated at the time of reporting. The reported data also shows that adverse events (unwanted medical occurrences during the trial) were recorded for 104 out of 104 assessed participants in the standard-of-care group and 108 out of 108 in the pralsetinib group, with serious adverse events recorded for 38 and 67 participants in those groups respectively. In the crossover pralsetinib group, all 38 participants experienced an adverse event, and 22 experienced a serious adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05388669 · results posted 2 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05388669) enrolled 418 people in total — 206 in one group who received a medicine called lazertinib together with amivantamab given as an injection under the skin (called SC-CF), and 212 in a second group who received lazertinib together with amivantamab given through a drip into a vein (called intravenous or IV). The trial was primarily measuring how much of the amivantamab medicine was present in participants' blood — specifically the amount remaining just before the next dose was due (called the "trough concentration") and the total amount of the drug in the blood over a set period of time. The reported data shows the following blood-level measurements for amivantamab. For the trough concentration measure used outside the European Union, the under-the-skin group had a reported value of 206 micrograms per millilitre, compared with 144 micrograms per millilitre in the drip group. For the trough concentration measure used in the European Union and certain other regions, the reported values were 335 micrograms per millilitre for the under-the-skin group and 293 micrograms per millilitre for the drip group. For the measure of total drug exposure in the blood over a 15-day window (called "area under the curve"), the reported figures were 135,861 and 131,704 micrograms-hour per millilitre for the under-the-skin and drip groups respectively. The reported data shows that three secondary outcomes — response rate (how many participants' disease responded), progression-free survival (how long before disease worsened), and duration of response (how long any response lasted) — were listed in the trial but no numerical results were submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05740566 · results posted 5 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05740566) enrolled 509 people with small cell lung cancer. Participants were split into two groups: 255 received standard of care treatment, and 254 received an investigational medicine called tarlatamab (given at doses ranging from 1 mg to 10 mg, every two weeks). The trial was set up to measure several things, including how long participants went without their disease getting worse (called progression-free survival), how their quality of life changed over time, and whether their tumours shrank or stopped growing. The reported data shows that, for all of the outcome measures listed — including progression-free survival, quality of life scores, tumour response rates, disease control rates, and how long any response lasted — no numerical results were submitted to ClinicalTrials.gov. The data fields for these outcomes are empty, meaning the specific numbers were not reported in the structured results available. It is not possible to describe what the trial found across any of these measures, as the figures were simply not provided in the submission. It is also worth noting that, according to the reported data, zero participants in either group were recorded as having "completed" the study, with all 509 listed under "not completed." This may reflect how the trial defined completion rather than indicating something went wrong, but no further explanation was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04916002 · results posted 5 December 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — CMP-001 and cemiplimab — in people with certain types of advanced skin cancer. The trial included 77 participants in total, spread across five groups: two groups with cutaneous squamous cell carcinoma (CSCC, a common type of skin cancer), two groups with Merkel cell carcinoma (MCC, a rarer skin cancer), and one group with basal cell carcinoma (BCC, another type of skin cancer). The trial was measuring how often tumours shrank or disappeared, how long any response lasted, and how long participants lived with or without their disease getting worse. It is noted that none of the participants were recorded as having "completed" the study in the formal sense under the trial's own definitions. The reported data shows that the main thing being measured — the proportion of participants whose tumours shrank or disappeared (called the "objective response rate") — varied considerably between groups. In Cohort A1 (25 people with CSCC who had not previously had immunotherapy), 44% showed a response, compared to just 5.3% in Cohort A2 (19 people with CSCC who had previously received immunotherapy). For the MCC groups, 46.2% of the 13 people in Cohort B1 showed a response, versus 6.3% of the 16 people in Cohort B2. In the small BCC group of 4 people, 25% showed a response. The reported data shows that for how long responses lasted (duration of response), a median of 11.3 months was recorded for Cohort A1, while this figure was not reported for the other groups. For how long participants went without their disease worsening (progression-free survival), the reported medians were 10.3 months (A1), 2.0 months (A2), 10.4 months (B1), 3.7 months (B2), and not reported for the BCC group. For overall survival, reported medians were 15.6 months (A1), 12.7 months (A2), not reported (B1), 9.9 months (B2), and not reported for the BCC group. The reported data also shows that all 77 participants across all groups experienced at least one treatment-emergent adverse event — meaning an unwanted health event that occurred during the treatment period. Serious adverse events were reported in 14 people in A1, 10 in A2, 6 in B1, 11 in B2, and 2 in the BCC group. The trial recorded the severity of these events on a scale from Grade 1 (mild) to Grade 5 (death related to the adverse event); detailed breakdowns for all groups and all severity grades were not fully reported in the submitted data for some cohorts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03132532 · results posted 25 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03132532) enrolled 20 people in total — 10 in each group. Both groups received platinum-based chemotherapy (a common type of cancer drug given as a drip) alongside a form of radiation therapy called proton beam therapy (PBT). One group received a lower radiation dose and the other received a higher radiation dose. The trial was measuring how long participants went without their disease getting worse (called progression-free survival), as well as a number of other things including how long participants lived overall, whether the cancer came back locally or spread to other parts of the body, and what unwanted side effects occurred. All 10 participants in the lower-dose group completed the study, while 7 out of 10 in the higher-dose group completed it. The reported data shows that for the main measurement — the proportion of participants who had not experienced disease progression — 0.6 (meaning 6 out of 10) in the lower-dose group and 0.429 (roughly 4 out of 7 who completed the study) in the higher-dose group were recorded in this category. For overall survival, the reported data shows 4 participants in the lower-dose group and 2 in the higher-dose group were recorded in one count, and 6 and 5 respectively in a second count — though the trial data as submitted does not clearly label what these two separate counts represent, so a precise plain-English description of each figure cannot be given. Regarding side effects, 9 out of 10 participants in the lower-dose group and 6 out of 10 in the higher-dose group were reported to have experienced side effects graded at level 2 or higher (on a scale where 5 is the most severe), with a second reported count showing 6 in the lower-dose group and 5 in the higher-dose group — again, the distinction between these two counts was not clearly labelled in the submitted data. The proportion of participants whose cancer returned in or near its original location was reported as 0.2 (1 in 5) for the lower-dose group and 0.14 (roughly 1 in 7) for the higher-dose group. The proportion in whom the cancer was recorded as spreading to other parts of the body was 0.1 for the lower-dose group and 0.29 for the higher-dose group. Quality of life data was listed as an outcome but no results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03334617 · results posted 27 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03334617) enrolled a total of 632 participants across 22 different treatment groups. It was a multi-part study testing several different drug combinations — all involving the immunotherapy drug durvalumab paired with one of a number of other investigational medicines — in people with cancer. The trial was divided into separate "modules," each testing a different drug combination in participants who were grouped based on features of their cancer. The main thing the trial set out to measure was how many participants had their tumours shrink or disappear (called an "objective response") according to standard imaging-based criteria. The reported data shows that the proportion of participants whose tumours shrank or disappeared varied considerably across the different treatment groups. Among the groups for which results were reported, the highest recorded rate was approximately 25.8% in the group receiving durvalumab combined with a drug called ceralasertib (Module 3, Cohort A). Several other groups recorded rates between roughly 4% and 9.5%, while a number of groups recorded 0% — meaning no participants in those groups met the criteria for a tumour response. Results for some groups (including Module 4 and several others) were not reported in the submitted data. On the secondary measures, the reported data shows that the median time participants lived without their disease getting worse (progression-free survival) ranged from around 1.4 months to 7.4 months across groups, and the median overall survival — the time from first treatment dose until death from any cause — ranged from approximately 5.75 months to 15.8 months across the groups where data was provided. Results for some groups were listed as not applicable or were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05513703 · results posted 24 October 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called telisotuzumab vedotin in 9 participants. All 9 received at least one dose of the study drug, and none were recorded as having completed the study — all 9 were listed as "not completed," though the reasons for this are not detailed in the data provided. The trial's main goal was to measure the **objective response rate** — that is, the proportion of participants whose tumours showed a confirmed meaningful shrinkage (either a complete or partial response) as judged by an independent review team. The reported data shows that 33.3% of participants (roughly 3 out of 9) had a confirmed tumour shrinkage response. The **disease control rate** — which also counts participants whose disease remained stable for at least 12 weeks, not just those who responded — was reported at 44.4%. For those who did respond, the reported data shows the response lasted a median of 8.5 months (median meaning half lasted longer, half shorter). The time from first dose until the disease progressed or a participant died — called **progression-free survival** — was reported as a median of 4.0 months. The **overall survival** figure, meaning the median time from first dose until death from any cause, was reported as 17.5 months. Changes in cough scores over time were also measured using a standard questionnaire; the reported data shows individual participant scores generally moved in a negative direction on the scale, which in this scoring system indicates a reduction in cough symptoms, though the data was not summarised as a single group average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04256421 · results posted 22 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04256421) enrolled 490 people in total — 247 in the group receiving a placebo plus atezolizumab (Arm A), and 243 in the group receiving tiragolumab plus atezolizumab (Arm B). The trial was measuring several things: how long participants went without their disease getting worse (progression-free survival, or PFS), how long they lived overall (overall survival, or OS), what proportion of participants saw their tumour shrink or disappear (objective response rate, or ORR), and how long those responses lasted (duration of response, or DOR). Notably, the data shows that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed" — the reasons for this were not detailed in the reported data. The reported data shows the following numbers for the full group of participants: the median time before disease worsening or death was 5.42 months in Arm A and 5.06 months in Arm B. Median overall survival was reported as 12.91 months in Arm A and 12.75 months in Arm B. When looking at the proportion of people whose tumour shrank or disappeared, the reported figures were approximately 65.6% in Arm A and 70.8% in Arm B across all participants, and 66.7% versus 73.5% in a subgroup analysed separately. For how long those responses lasted, the reported median figures were 5.11 months (Arm A) and 4.17 months (Arm B) across all participants, and 5.59 months versus 4.19 months in the subgroup. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03307759 · results posted 15 September 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total — 5 in one group who received radiation therapy (called SABR) followed by an immunotherapy drug called pembrolizumab, and 8 in a second group who received pembrolizumab first and then the radiation therapy. The trial was investigating the order in which these two treatments were given, and was primarily looking at serious side effects. It also measured how tumours responded to treatment and how many participants were still alive at around two years. The reported data shows that when it came to serious (Grade 3) treatment-related side effects — meaning significant harmful reactions linked to the treatment — none of the 5 participants in the first group experienced one, while 1 out of the 8 participants in the second group did. For tumour response (measured by standard imaging-based scoring systems), the reported data shows that 4 out of 5 participants in the first group and 4 out of 8 in the second group showed an overall response under two different CT-based measurement methods. Using two PET scan-based measurement methods, 3 out of 5 in the first group showed a response, compared to 3 or 4 out of 8 in the second group depending on which method was used. For overall survival at around two years, the reported data shows 80% of participants in the first group and 50% in the second group were alive, though it is important to note these are very small numbers of people. It is worth noting that with only 13 participants across both groups, this was a very small trial, and the reported numbers should be understood in that context. No data was reported for some additional measures that may have been planned. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02819024 · results posted 22 August 2025
According to the results reported on ClinicalTrials.gov, six people took part in this trial, and five completed it (one did not finish). All participants were in a single group that received dexamethasone (a steroid medicine) and underwent a type of specialised scan called an 18F-FLT PET scan. This scan measures how quickly cells in a tumour are dividing and growing. The trial was looking at whether this type of scan could detect changes in tumour activity after treatment, and also at changes in certain biological markers in the blood linked to a process called cellular senescence (a state where cells stop dividing). The reported data shows that, on average, the tumour activity measurement — called SUVmax, which is a score the PET scan produces to reflect how active tumour cells are — decreased by 0.39 units across the group. For the blood markers, the reported data shows the levels of three substances associated with senescence changed over the course of the trial: Gro-alpha showed a 2.46-fold change, Gro-beta showed an 8.34-fold change, and MCP-1 showed a 14.8-fold change (a "fold change" simply means how many times higher or lower a measurement was compared to the starting point). For a fifth measure — a tumour protein called Glucocorticoid Receptor Alpha — no numerical results were reported in the data submitted. It is worth noting that this was a very small trial with only six participants, so the numbers above represent a very limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04579679 · results posted 25 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 78 people in total across four groups, all of whom had a type of tumour called a neuroendocrine tumour (NET) originating from different parts of the body: the lung (20 people, Cohort A), the small bowel (32 people, Cohort B), other locations (20 people, Cohort C), and a mixed "any NET" group (6 people, Cohort D). The trial was measuring how participants' tumours responded to a medicine called surufatinib, looking mainly at whether tumours shrank, stayed stable, or continued to grow. The reported data shows that the primary measure — called the Disease Control Rate — reflects the percentage of participants whose tumours either shrank or stayed stable (rather than growing). The reported figures were 95% for the lung group, 90.3% for the small bowel group, 89.5% for the other NET group, and 100% for the mixed group. A separate measure — the percentage of participants whose tumours actually shrank by a meaningful amount — was reported as 15% (lung), 16.1% (small bowel), 5.3% (other), and 20% (mixed group). Among those whose tumours did shrink, the reported time until that first shrinkage was seen ranged from about 2.1 months (lung group) to 13.6 months (mixed group), and the reported length of time that shrinkage was maintained ranged from 5.6 months to 16.9 months across groups (the mixed group result was not reported). The trial also measured the levels of surufatinib in the blood and monitored a heart rhythm interval called the QT interval; specific number values for those measures were recorded in the data, though detailed interpretation was not provided in the results submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04026412 · results posted 24 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04026412) enrolled 925 people across three treatment groups. Arm A (287 people) received nivolumab combined with a type of radiation-plus-chemotherapy treatment, followed by nivolumab and ipilimumab. Arm B (320 people) received the same starting treatment followed by nivolumab alone. Arm C (318 people) received the radiation-plus-chemotherapy treatment followed by durvalumab. The trial was primarily measuring how long participants went without their disease getting worse — known as "progression-free survival" — comparing Arm A against Arm C. The reported data shows that, for the primary measure, the median time without disease progression was approximately 16.7 months in Arm A and 15.6 months in Arm C. For overall survival — meaning the median time participants were alive from the start of the trial — the reported figures were approximately 34.6 months in Arm A, 39.5 months in Arm B, and 39.8 months in Arm C. The reported data also shows that when looking at progression-free survival across all three arms, the figures were roughly 16.8 months (Arm A), 17.4 months (Arm B), and 15.7 months (Arm C). In terms of the proportion of participants whose tumours shrank to a meaningful degree, the reported figures were 67.6% in Arm A, 72.2% in Arm B, and 64.5% in Arm C. For those who did respond, the response lasted a reported median of approximately 25.8 months (Arm A), 31.8 months (Arm B), and 25.2 months (Arm C), with responses first appearing at around 2.9 months across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04656652 · results posted 23 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04656652) enrolled 604 people with lung cancer — 299 received a treatment called DS-1062a (also known as datopotamab deruxtecan) at a dose of 6.0 mg/kg, and 305 received a standard chemotherapy called docetaxel. The trial was measuring two main things: how long participants went without their cancer getting worse (called progression-free survival), and how long participants lived overall (called overall survival). A smaller number of participants in each group completed the full study period — 68 in the DS-1062a group and 62 in the docetaxel group. The reported data shows that, for the main outcomes, participants in the DS-1062a group went a median (middle value across all participants) of 4.4 months without their disease getting worse, compared with 3.7 months in the docetaxel group, as assessed by an independent review panel. For overall survival, the reported median was 12.9 months in the DS-1062a group and 11.8 months in the docetaxel group. For secondary outcomes, the reported data shows that 79 participants in the DS-1062a group and 39 in the docetaxel group had their tumour shrink or disappear (based on independent review), and that among those whose tumour did respond, the response lasted a median of 7.1 months (DS-1062a) versus 5.6 months (docetaxel) by independent review, and 9.6 months versus 6.4 months by the treating doctors' assessment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04921358 · results posted 29 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 377 people with a type of lung cancer who had already received prior treatment. Participants were randomly assigned to receive either a combination of two medicines — tislelizumab and sitravatinib — or a standard chemotherapy medicine called docetaxel. The trial was measuring how long people lived overall, how long they lived before their disease got worse, and how many people's disease responded to or was controlled by treatment. The reported data shows that for overall survival (how long participants lived from the start of the trial), the median — meaning the midpoint, where half of participants lived longer and half lived shorter — was 11.5 months in the combination group and 11.4 months in the docetaxel group. For progression-free survival (how long before the disease got worse or a participant died), the median was 4.4 months in the combination group and 2.9 months in the docetaxel group, as measured both by an independent review committee and by the treating doctors. The proportion of participants whose tumours shrank to a meaningful degree was reported as 12.3% in the combination group and 12.6% in the docetaxel group. Among those whose tumours did respond, the combination group maintained that response for a median of 6.0 months; a comparable figure for the docetaxel group was not reported in the data. The reported data also shows that 69.5% of participants in the combination group had their disease either respond or remain stable, compared with 53.7% in the docetaxel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06094296 · results posted 16 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06094296) was designed to test a combination of medicines — BMS-986315, nivolumab, and chemotherapy chosen based on tumour type — across two planned parts and multiple treatment groups. The trial was set up to enrol participants across four groups. However, the reported data shows that only **one person** was enrolled in total, placed in the first group (Part 1), and that person did not complete the study. No participants were enrolled in the other three groups (Part 2 Arms A, B, or C). The reported outcome numbers from Part 1 are based solely on that single participant. According to the results reported on ClinicalTrials.gov, that one participant experienced at least one adverse event (an unwanted medical occurrence during the trial) and at least one treatment-related adverse event (an unwanted occurrence considered connected to the study medicines). However, the reported data shows that no serious adverse events (those involving hospitalisation, life-threatening situations, or death) were recorded. The data also shows no adverse events met the protocol's criteria for a "dose-limiting toxicity" (a side effect serious enough to prevent increasing the dose), no adverse events led to stopping treatment, and the participant did not die during the study. Because the trial enrolled only one person, no outcome data was reported for any of the Part 2 groups. The reported data shows that due to the very small number of participants — just one — the results from this trial are extremely limited and cannot be used to draw any broad conclusions about the medicines being tested. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01853826 · results posted 11 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT01853826) enrolled 481 participants, all of whom were in a single group receiving the drug afatinib. Of those, 479 actually received the treatment. The trial was primarily measuring how many participants experienced unwanted or unexpected health events (called adverse events) while taking afatinib, using a standard medical checklist known as CTCAE version 3.0 — a common tool used to record and grade these kinds of events in clinical trials. The reported data shows that out of the 479 participants who received afatinib, 478 had at least one adverse event recorded during the study period. It is worth noting that the data shows zero participants were recorded as having "completed" the study in the formal sense, with all 481 listed under "not completed" — though the reasons for this were not detailed in the submitted results. No secondary outcome measure data was included in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04786964 · results posted 2 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04786964) enrolled 25 people in total — 19 in the Cosibelimab group and 6 in the Control group. All 25 participants completed the study period. The trial was designed to measure several things related to a cancer treatment: how long participants lived overall, how long they lived without their disease getting worse, how many showed a measurable reduction in their cancer, how long any such reduction lasted, and how many participants experienced any unwanted medical events (called adverse events) during the study. The reported data shows that for most of the key outcomes — overall survival, progression-free survival, objective response rate, and duration of response — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to describe. The only outcome measure with reported numbers relates to adverse events (any unwanted medical occurrence during the study, whether or not it was thought to be related to the treatment). According to the reported data, 14 out of 19 participants in the Cosibelimab group and 6 out of 6 participants in the Control group experienced at least one adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05834348 · results posted 30 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05834348) enrolled a total of 5,279 people with a type of lung cancer called non-small cell lung cancer (NSCLC). Participants were split into two groups: 618 people in the "Biomarker Cohort" — meaning their tumours were tested for specific genetic markers (EGFR, ALK, or ROS1) — and 4,661 people in the "Non-biomarker Cohort," whose tumours did not have those markers identified. The trial was observational, meaning it tracked real-world treatment patterns and outcomes rather than testing a new drug, looking at how long people stayed on their cancer treatments and how long they survived after starting treatment. The reported data shows that, for people in the Biomarker Cohort, the median time spent on first-line (initial) treatment varied by genetic marker type, with figures ranging from 5 to 20 months depending on the subgroup. When all lines of treatment were counted together, the median total time on treatment ranged from 15.8 to 28 months across those subgroups. For overall survival — the time from starting treatment until death from any cause — the reported data shows a median of 19 months for the Biomarker Cohort compared to 5 months for the Non-biomarker Cohort. Some subgroups within the Biomarker Cohort had survival figures of 23–24 months, while a small number of subgroups had results listed as "not available" (meaning the data was not reported for those groups). In terms of cancer stage at diagnosis, the reported data shows the large majority of participants in both groups were at the most advanced stages (Stage 4A or 4B). Regarding tumour type, approximately 94.7% of the Biomarker Cohort and 80.8% of the Non-biomarker Cohort had a subtype called adenocarcinoma. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02486718 · results posted 30 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02486718) involved people who had been treated for non-small cell lung cancer (NSCLC) that had been surgically removed. The trial had two phases: first, 1,280 people were enrolled and assessed, with 1,005 completing that initial phase. Then, 1,005 of those participants were randomly assigned to receive either atezolizumab (507 people) or best supportive care — meaning standard monitoring and symptom management without additional cancer treatment (498 people). The trial was primarily measuring "disease-free survival" (DFS), which means how long participants went without their cancer coming back or a new lung cancer appearing, or without dying — whichever happened first. The reported data shows that, across all randomly assigned participants, the estimated median time before cancer recurrence or death was 65.6 months in the atezolizumab group compared with 47.8 months in the best supportive care group. When looking only at participants with more advanced disease stages (Stage II–IIIA), the reported figures were 57.4 months versus 40.8 months. Within that Stage II–IIIA group, for participants whose tumour cells tested positive for a particular protein marker called PD-L1 (at 1% or above), the reported figures were 68.5 months versus 37.3 months. For secondary outcomes, the reported data shows that at the three-year mark, an estimated 61.4% of the atezolizumab group and 55.5% of the best supportive care group (across all participants) were disease-free; in the Stage II–IIIA group alone, those figures were 59.3% and 52.6% respectively. Overall survival data was listed as a secondary outcome but no figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04495894 · results posted 4 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04495894) looked at giving a pain-relief medicine called ketorolac before surgery to people with one of two types of cancer — non-small cell lung cancer (NSCLC) or kidney cancer (renal cell carcinoma, RCC). In total, 68 people started the trial across four groups: those with lung cancer who received ketorolac (16 people) or did not (6 people), and those with kidney cancer who received ketorolac (33 people) or did not (13 people). After some participants dropped out before completing the study activities, the final numbers who completed the trial were 14, 6, 28, and 10 respectively. The trial was primarily measuring a range of post-surgery events related to bleeding and other complications before participants left hospital. The reported data shows the following for each of the main outcomes measured. For blood transfusions needed after surgery: 0 out of 14 lung cancer participants who received ketorolac needed one, compared with 0 out of 6 in the lung cancer control group; in the kidney cancer groups, 2 out of 28 who received ketorolac and 2 out of 10 in the control group needed a transfusion. For significant blood pooling under the skin (haematoma): 0 in both lung cancer groups, 1 out of 28 in the ketorolac kidney cancer group, and 0 in the kidney cancer control group. For needing to return to the operating theatre due to bleeding: 0 participants across all four groups. For kidney failure after surgery: 0 in both lung cancer groups, 0 in the ketorolac kidney cancer group, and 1 out of 10 in the kidney cancer control group. For overall post-surgery complications (at least one adverse event of any kind): 6 out of 14 in the ketorolac lung cancer group, 1 out of 6 in the lung cancer control group, 14 out of 28 in the ketorolac kidney cancer group, and 6 out of 10 in the kidney cancer control group. A planned analysis of biological pathways (transcriptome analysis) was listed but no data was reported for this outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03976323 · results posted 6 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03976323) enrolled 1,003 people in an initial "induction phase," where everyone received a combination of pembrolizumab, pemetrexed, and platinum-based chemotherapy. Of those, 672 completed that phase. Then, 672 participants who responded well enough moved into a "maintenance phase," where they were split into two groups: 337 people received pembrolizumab plus olaparib, and 335 received pembrolizumab plus pemetrexed. The trial was measuring two main things — how long people went without their cancer growing (called progression-free survival), and how long people lived overall (called overall survival). The reported data shows that, for the primary outcomes during the maintenance phase, the pembrolizumab plus olaparib group had a median progression-free survival of 7.1 months, compared with 8.3 months in the pembrolizumab plus pemetrexed group. Median overall survival was reported as 20.7 months in the olaparib group and 23.0 months in the pemetrexed group. (A "median" figure means half of the participants in each group reached that time point, and half did not.) For quality-of-life scores — measured using a standardised questionnaire where higher scores indicate better wellbeing — both groups showed a small decline from their starting scores over time, with the olaparib group reporting a change of −5.34 points and the pemetrexed group reporting −3.44 points. The time until participants experienced a meaningful drop (10 or more points) in their quality-of-life score was reported as approximately 19.8 months in the olaparib group and 17.3 months in the pemetrexed group. The data for adverse events (unwanted medical occurrences) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05089734 · results posted 14 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05089734) enrolled 299 people in the Sacituzumab Govitecan (SG) group and 304 people in the Docetaxel group — 603 participants in total. The trial was comparing these two treatments in people with a type of lung cancer, measuring how long participants lived overall, how long it took for their disease to progress, and how many showed a measurable reduction in their tumours. The reported data shows that for overall survival — the time from joining the trial until death from any cause — the median figure (meaning half of participants lived longer than this, and half did not) was 11.1 months for the SG group and 9.8 months for the Docetaxel group. For progression-free survival — the time until the disease visibly worsened or death occurred — the reported medians were 4.1 months (SG) and 3.9 months (Docetaxel). When looking at the proportion of participants whose tumours shrank by a meaningful amount (called the objective response rate), the reported figures were 13.7% in the SG group and 18.1% in the Docetaxel group. Among those who did respond, the response lasted a reported median of 6.7 months (SG) and 5.8 months (Docetaxel). The proportion of participants whose disease either shrank or stayed stable (disease control rate) was reported as 67.6% (SG) and 67.1% (Docetaxel). Data on side effects experienced during treatment was listed as an outcome measure, but the specific figures were not reported in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01463423 · results posted 19 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 256 people with lung cancer across three groups: 84 people with early-stage (limited) non-small cell lung cancer (NSCLC), 87 people with a history of NSCLC, and 85 people with advanced or spread (metastatic) lung cancer. The trial was measuring how well a precisely targeted form of radiation treatment called Stereotactic Ablative Radiotherapy (SABR) could keep tumours under control, and also tracked side effects and survival over time. The reported data shows that for the primary measure — the number of tumour lesions that remained under control one year after SABR — the figures varied across groups, but full details of how all measurements were categorised were not clearly separated in the submitted data. For side effects (specifically serious ones graded at level 3 or higher, meaning significant or severe reactions), the reported data shows these were recorded in 19 participants in the early-stage group, 31 in the history-of-NSCLC group, and 18 in the advanced cancer group. For the survival measures taken at two years after treatment — looking at participants who were alive without their disease progressing, and alive without new spread to other parts of the body — the reported numbers were 23, 26, and 14 participants respectively across the three groups. Two secondary outcomes relating to a breath-holding technique used during treatment had no data reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03523702 · results posted 3 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03523702) enrolled 25 people, all of whom completed the study. Participants had a type of lung cancer called locally advanced non-small cell lung cancer (NSCLC) and a high level of a protein marker called PD-L1 (at least 50%). The trial looked at what happened to participants after they received a sequence of two treatments — a medicine called pembrolizumab followed by radiotherapy (targeted radiation). The main thing researchers were tracking was how many participants went 12 months without their cancer getting worse (called progression-free survival). The reported data shows that, out of the 25 participants, 19 had not experienced cancer progression at the 12-month mark. For the additional measures tracked: 17 participants were reported as free from the cancer spreading to distant parts of the body at 18 months; 22 participants did not have disease progression within the chest area; and 23 participants were still alive at one year, with 19 still alive at two years. When it came to how tumours responded on scans, 1 participant showed a complete response (all detectable tumour gone), 11 showed a partial response (tumour shrank by at least 30%), 11 had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), and 2 had progressive disease (tumour grew). The data for unplanned hospital admissions due to treatment-related side effects was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05171777 · results posted 21 November 2024
According to the results reported on ClinicalTrials.gov, this trial looked at whether people receiving a cancer treatment called atezolizumab preferred getting it as a subcutaneous (SC) injection — a short jab under the skin — or as an intravenous (IV) infusion, which is delivered through a drip into a vein and takes longer. The trial enrolled participants in two main phases: a "crossover" phase, where 89 and 90 people (in two groups) each tried both the injection and the drip in different orders, and a "continuation" phase involving a separate group of 26 people on IV and 89 on SC. Participants were asked questions about their preferences and satisfaction, and healthcare staff were also asked about preparation time and workload. The reported data shows that, overall, approximately 71% of participants who answered the preference question said they preferred the SC injection over the IV drip. When broken down by group, the figure was about 72% among those who received IV first then SC, and about 70% among those who received SC first then IV. When asked at the end of the crossover phase which method they wanted to continue with, around 78% and 77% of participants (in the two groups respectively) chose the SC injection for their ongoing treatment. On satisfaction, the reported data shows a spread of responses across "very satisfied," "satisfied," and "neither satisfied nor dissatisfied" for both methods, though exact breakdowns across all categories were reported in the data. Regarding healthcare staff, preparation time for both methods was reported as approximately 5 minutes, and a majority of staff — roughly 60–72% depending on the group — reported that the SC method was quicker overall from preparation to end of administration. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04866017 · results posted 31 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04866017) enrolled 63 people across three groups. Twenty-two participants received a combination of two immunotherapy medicines — ociperlimab and tislelizumab — alongside a standard radiation-and-chemotherapy treatment (called concurrent chemoradiotherapy, or cCRT). Nineteen participants received tislelizumab plus cCRT, and 22 received cCRT followed by a different immunotherapy medicine called durvalumab. The trial was set up to measure how long people went without their cancer growing or spreading (called progression-free survival), as well as several other measures such as overall survival (how long people lived), how many people's cancer shrank or disappeared, and how long any such response lasted. The reported data shows that no numerical results were submitted for any of the outcome measures — including the primary measure of progression-free survival and all secondary measures such as overall survival, response rate, duration of response, time to distant spread, and longer-term progression-free survival. In other words, the actual figures for these outcomes were not reported in the structured data on ClinicalTrials.gov. It is also worth noting that zero participants across all three groups are recorded as having "completed" the study, with all participants listed under "not completed," though the reasons for this were not detailed in the data provided. Because no outcome numbers have been submitted, it is not possible to describe what the trial found in terms of measurable results. The reported data shows only that the trial ran, that participants were treated, and that result figures are currently absent from the public record on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04889989 · results posted 15 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04889989) enrolled 13 participants who underwent a procedure called microwave ablation — a technique that uses heat generated by microwaves to target tumours in the lung. The trial was measuring how completely the ablation procedure covered the tumours, as well as tracking things like whether tumours came back at the treated site and how many participants were still alive one year later. Of the 13 who started, 6 completed the full study, while the remaining 7 did not complete it for various reasons including 1 who withdrew consent, 1 who passed away, and 1 who was lost to follow-up. Four participants were classed as "run-in," meaning they took part in an early lead-in phase of the trial. The reported data shows that for the main outcome — whether tumours were completely covered by the ablation zone with no sign of abnormal activity on a specialised CT scan — 8 tumours met this standard, as assessed by an independent review committee. For a related measure looking at how well the ablation covered each tumour immediately after the procedure, 9 tumours were recorded as meeting the required classification. The reported data also shows that 1 tumour showed signs of growing back at the treated site after the procedure. Regarding survival at one year after ablation, 12 out of 13 participants were reported as still alive, and 10 out of 13 were reported as alive without any sign of disease progression (meaning no evidence of the disease spreading or worsening at any site). It is worth noting that this was a small study with only 13 participants, and the total number of tumours assessed was not separately specified in the submitted data — only the number of tumours meeting each measurement criterion was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04487080 · results posted 9 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04487080) enrolled 1,074 people in total across three groups. The largest two groups had 429 participants each, and the third had 216 participants. Each group received a different combination of medicines: one group received amivantamab plus lazertinib together (open-label, meaning everyone knew what was being taken); one received osimertinib plus a dummy pill (placebo); and one received lazertinib plus a dummy pill. The main thing the trial was measuring was how long participants went without their cancer growing or spreading — a period called "progression-free survival." The reported data shows that the median time before disease progression or death was approximately 23.7 months in the amivantamab-plus-lazertinib group, 16.6 months in the osimertinib-plus-placebo group, and 18.5 months in the lazertinib-plus-placebo group. (Median here simply means the middle value — half of participants in each group reached that point before or after that time.) These figures were assessed by an independent review team who did not know which treatment each participant had received. The reported data shows that several other planned measurements — including overall survival (how long participants lived), the proportion whose tumours responded to treatment, how long those responses lasted, and others — were listed as secondary outcomes but no numerical results were submitted to ClinicalTrials.gov for those measures at the time of this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03293680 · results posted 3 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03293680) enrolled 83 participants, all of whom received pembrolizumab. The trial was designed to look at outcomes in older patients (aged over 70) with advanced non-small cell lung cancer, with the main focus on how long participants lived after starting treatment. Seventy-four participants completed the study, and nine did not. The reported data shows that the median overall survival — that is, the midpoint length of time that participants were still alive after starting treatment — was 19.2 months. For participants whose tumour had lower levels of a particular protein marker (PD-L1 under 50%), the reported median overall survival was 16.5 months. The reported data also shows that 40.2% of participants were still alive at the two-year mark. For progression-free survival — the midpoint length of time before the disease showed signs of getting worse — the reported figure was 6.1 months. On a quality-of-life questionnaire (scored from 0 to 100, where higher scores on functional scales mean better functioning), two measurements were reported for the participant group: 66.7 and 92.3, though the data does not specify which time points these correspond to. On a separate daily functioning scale (the Barthel scale, where 100 means fully independent), the reported scores across seven measurement points were mostly 100, with one score of 97. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02492867 · results posted 3 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people, all of whom received a form of radiation therapy that was adjusted during treatment based on how their tumour was responding — described as "response-driven adaptive radiotherapy." Of the 47 who started, 42 completed the study and 5 did not. The trial was primarily measuring whether this adjusted approach could be delivered as planned, and also tracking certain side effects involving the lungs and oesophagus (the tube connecting the throat to the stomach). A secondary goal was to track how long participants went without their cancer progressing locally, and how long they survived overall. The reported data shows that out of 47 participants, 40 were able to receive the full planned treatment within the required timeframe, which was the trial's main measure of feasibility. Regarding side effects, the data reports that 8 participants experienced grade 2 or higher lung-related side effects (meaning moderate or worse), with smaller numbers — 1 and 6 — recorded at varying severity levels, and 1 participant at a higher grade; 0 were recorded at another level. For oesophageal side effects of grade 2 or higher, the reported figures were 1, 9, and 7 participants across different severity categories. The reported data also shows that the average radiation dose actually delivered to the tumour area under this adaptive approach was 80.4 Gy (a unit measuring radiation dose), compared to 67.7 Gy that would have been delivered under an older treatment protocol. For the secondary measures, the reported data shows that approximately 69.2% of participants had not experienced local cancer progression at one time point, dropping to around 47.9% at a later point. For overall survival, the reported figures were 82.8% and 62.3% of participants alive at two separate time points — though the specific time intervals for these figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03456076 · results posted 26 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03456076) enrolled 257 people in total — 130 received alectinib (a targeted tablet medicine) and 127 received platinum-based chemotherapy (a standard intravenous cancer treatment). The trial was comparing these two treatments in people who had been operated on for a type of lung cancer, and the main thing it was measuring was "disease-free survival" — that is, how long participants went without their cancer coming back or a new lung cancer appearing, or how long they survived, whichever came first. The reported data shows that for disease-free survival, a final median figure (the point at which half the group had experienced an event) was not reported for the alectinib group, while the chemotherapy group had a reported median of 44.4 months in one measurement and 41.3 months in another. The overall survival data — tracking how long participants lived overall — was listed as a secondary outcome but no numbers were reported in the submitted results. Regarding undesirable medical events (called adverse events) that were recorded during the study, the reported data shows these were noted in 98.4% of alectinib participants and 93.3% of chemotherapy participants. Among more serious (grade 3–5) events where the difference between groups was at least 2%, figures varied by event type across both groups. The reported data also includes blood concentration levels of alectinib and one of its breakdown products (metabolite M4) measured at various time points during treatment, with alectinib levels ranging roughly from 382 to 639 ng/mL and M4 levels ranging roughly from 178 to 238 ng/mL across those time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04166240 · results posted 6 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04166240) looked at how well healthcare sites followed up on abnormal test results — specifically, whether patients were notified about those results in a timely way. The trial was set up in three sequences (groups of sites that received an intervention at different points in time), which is a common design used to test a process or programme across multiple locations in a staggered way. Unfortunately, the reported data does not include how many individual participants were enrolled, as those figures were listed as "not available" across all groups and time periods. The reported data shows results for the main (primary) outcome measuring the percentage of abnormal test results that received timely follow-up. For one of the measures — called the "Trigger Outcome," which tracked missed test results using electronic indicators — the figures reported were: Sequence 1 had 67.0% and 78.1% (across two time points), Sequence 2 had 65.9% and 67.7%, and Sequence 3 had 78.6% and 78.2%. These percentages represent how often abnormal tests were followed up on in a timely manner at each group of sites. A second primary outcome — which looked at whether patients were notified of actionable test results within seven days, measured through an external review programme — had no data reported at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04035486 · results posted 6 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04035486) involved 587 people in total. Thirty participants took part in an initial safety check phase — 15 receiving the drug AZD9291 (osimertinib) combined with carboplatin and pemetrexed (types of chemotherapy), and 15 receiving AZD9291 combined with cisplatin and pemetrexed. The remaining 557 participants were randomly assigned to receive either AZD9291 plus chemotherapy (279 people) or AZD9291 alone (278 people). The trial was primarily measuring how long participants went without their cancer growing or spreading — known as "progression-free survival" — as well as tracking side effects in the initial safety phase. The reported data shows that, in the randomly assigned group, the median progression-free survival (that is, the midpoint time before disease progressed or death occurred) was 25.5 months for those who received AZD9291 plus chemotherapy, compared with 16.7 months for those who received AZD9291 alone. A separate check using an independent review panel reported figures of 29.4 months and 19.9 months respectively for the same two groups. For the initial safety phase participants (combined across both chemotherapy types), the reported data shows that 86.7% had a measurable reduction in their tumour, and the median duration of that response was 27.5 months. Overall survival figures for the safety phase were not reported in the submitted data. Side-effect severity was recorded across five grades in the safety phase, though the overall survival data for that group was listed as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03743064 · results posted 26 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 318 people in total — 154 received a daily 100 mg dose of a drug called anamorelin HCl, and 164 received a placebo (a dummy treatment with no active ingredient). The trial was looking at two main things over 12 weeks: whether participants' body weight changed, and whether their appetite-related symptoms changed, as measured by a short five-question survey about appetite and eating (called the 5-IASS, where higher scores mean fewer symptoms). The reported data shows that, on average, people in the anamorelin group had a mean body weight change of +1.82 kg over the 12 weeks, compared with +0.54 kg in the placebo group. For the appetite symptom score, the anamorelin group had an average improvement of 3.43 points, while the placebo group had an average improvement of 3.29 points. The reported data also shows some secondary measurements about how long participants maintained a weight change or symptom improvement. For body weight, the anamorelin group maintained a weight at or above their starting weight for an average of about 8.9 weeks, compared with about 6.8 weeks for the placebo group. For a more meaningful weight gain threshold of 1.5 kg or more, those figures were about 5.5 weeks versus 3.1 weeks respectively. For the appetite symptom score, the duration results were more similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04642469 · results posted 25 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04642469) enrolled 30 people in total — 15 who received a medicine called durvalumab and 15 who received a placebo (an inactive treatment used for comparison). The trial was measuring **disease-free survival** — that is, how long participants went without their disease coming back or dying from any cause. It was a randomised, placebo-controlled study, meaning participants were assigned to one group or the other by chance. The reported data shows that, on average, the time before disease recurrence or death was **3.9 months** in the durvalumab group and **2.0 months** in the placebo group. These are the median figures — meaning half the participants in each group reached that point before or after that time. Regarding reported side effects, the data shows that 13 out of 15 participants in the durvalumab group and 10 out of 15 in the placebo group experienced at least one adverse event (an unexpected medical occurrence during the study). One participant in each group experienced a serious adverse event — a more significant medical occurrence as defined by the study. It is worth noting that only 1 participant in the placebo group and none in the durvalumab group were recorded as having completed the study; the reasons for non-completion were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04194944 · results posted 20 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04194944) enrolled 261 people in total — 159 in the selpercatinib group and 102 in the chemotherapy group (who received pemetrexed and platinum, with or without an additional drug called pembrolizumab). The trial was primarily measuring "progression-free survival" — that is, how long participants went before their disease was recorded as getting worse, or before they died. The reported data shows that, as assessed by an independent review team, participants in the selpercatinib group went a median of 24.84 months before disease progression or death, compared with a median of 11.17 months in the chemotherapy group. (A "median" simply means that half the participants in each group reached that point before that time, and half after it.) This figure was the same whether or not pembrolizumab was included in the comparison. For a secondary measure called "disease control rate" — the proportion of people whose disease was recorded as completely gone, partially reduced, or stable for at least 16 weeks — the reported data shows approximately 89% in the selpercatinib group versus approximately 82–84% in the chemotherapy group, depending on which subgroup was analysed. Two other secondary measures, relating to how long people went without progression on their *next* treatment after the trial (called PFS2), were not reported in the submitted data for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03847519 · results posted 4 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03847519) enrolled a total of 24 people across three groups. Seven participants took part in Part A, which tested a treatment called ADXS-503 on its own. Fourteen took part in Part B, and three in Part C — both of which combined ADXS-503 with another treatment called pembrolizumab. The trial was mainly looking at two things: how many people experienced treatment-related side effects, and whether tumours showed any measurable response to the treatments (defined as the tumour either disappearing completely or shrinking by at least 30%). The reported data shows that in Part A (ADXS-503 alone), 4 out of 7 participants had treatment-related side effects recorded. In Part B (the combination), 11 out of 14 participants had treatment-related side effects recorded. In Part C (also the combination), 2 out of 3 participants had treatment-related side effects recorded. When it came to tumour response, the reported data shows that in Part C, zero out of 3 participants met the criteria for a measurable tumour response. Looking at the earlier parts, zero out of 7 participants in Part A showed a measurable tumour response, while 1 out of 14 participants in Part B did. Very few participants completed the full study — only 1 in Part A, 1 in Part B, and none in Part C. It is worth noting that this was a small, early-phase trial, so the numbers involved are quite limited. The reported data shows the measurements that were collected, but no conclusions about whether the treatment works or is safe can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04051827 · results posted 12 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04051827) enrolled 26 participants who received both midazolam (a medicine commonly used as a sedative) and mobocertinib (a cancer medicine). The trial was designed to measure how the presence of mobocertinib in the body affects the way midazolam is absorbed and processed — in other words, whether taking the two medicines together changes how midazolam behaves in the bloodstream compared with taking it alone. Notably, the reported data shows that none of the 26 participants were recorded as having "completed" the study, with all 26 listed under "not completed," though no further explanation for this is provided in the submitted data. The reported data shows results for several blood-level measurements of midazolam. When midazolam was taken by mouth alone, the peak blood concentration (the highest level measured in the blood) was reported as 17.0 ng/mL, compared with 17.5 ng/mL when taken alongside mobocertinib. The total exposure to midazolam over time (a measure of how much of the medicine the body absorbed overall) was reported as 58.3 ng·h/mL when taken alone, and 39.0 ng·h/mL when taken with mobocertinib. For midazolam given directly into a vein, the peak blood concentration was 70.8 ng/mL alone versus 92.2 ng/mL with mobocertinib, and the total exposure was 90.4 ng·h/mL alone versus 71.6 ng·h/mL with mobocertinib. The time it took for midazolam to reach its peak level in the blood was reported as approximately 0.52 hours (oral) and 0.05 hours (intravenous) under both conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02247349 · results posted 5 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people across six groups, each receiving different doses of a drug called BMS-986012 — either on its own (at doses of 70mg, 160mg, 400mg, or 1,000mg) or combined with another drug called nivolumab (at 400mg or 1,000mg doses). The trial was primarily measuring how many participants experienced adverse events (unexpected medical occurrences or worsening health during the study), serious adverse events, discontinuations due to adverse events, deaths from any cause, and abnormal liver test results. A secondary focus was on how much of the drug was present in participants' blood after dosing. The reported data shows that across all six groups, every participant who started the trial experienced at least one adverse event — that is, all 7, 6, 29, 35, 21, and 8 participants in each respective group. Serious adverse events (those involving hospitalisation, life-threatening situations, death, or other significant outcomes) were recorded in 7, 4, 21, 24, 11, and 5 participants across the groups. The reported data shows that adverse events led to discontinuation for 0, 1, 2, 5, 3, and 2 participants respectively. Deaths from any cause were recorded for 3, 2, 10, 16, 2, and 4 participants across the groups. Abnormal liver test results were uncommon, with only a small number of participants (at most 2 in any group) showing the specific liver abnormalities that were tracked. For the secondary measure, the reported data shows the peak blood concentration of BMS-986012 varied across groups and time points, ranging from approximately 27.5 to 339 micrograms per millilitre depending on the dose and whether nivolumab was also given; some time-point data for the combination groups was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03257722 · results posted 28 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03257722) was a Phase 1 study looking at combining two medicines — idelalisib and pembrolizumab — in people with a type of lung cancer (non-small cell lung cancer) that had stopped responding to a certain type of immunotherapy. The trial was designed to find out whether the combination caused serious side effects (called dose-limiting toxicities, or DLTs — meaning side effects severe enough to limit the dose) and to identify the best dose to use in future research. Only 2 participants were enrolled in the 50 mg dose group, and neither of them completed the study. The reported data shows that both of the 2 participants who started the trial experienced a dose-limiting toxicity event. For the second outcome — identifying the optimal recommended dose for a potential future Phase 2 study — no result was reported, meaning that a recommended dose was not determined. The reported data also shows that zero participants had a measurable reduction in their tumour according to the standard measurement criteria used (known as RECIST), though it is worth noting that only 2 people were enrolled, which is a very small number. Because the trial closed early with only 2 participants, the results are based on a very limited amount of data and the study did not reach its intended size or complete its planned phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03515837 · results posted 17 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03515837) enrolled 492 people with lung cancer — 245 in one group who received pembrolizumab combined with pemetrexed and chemotherapy, and 247 in a second group who received a placebo combined with the same chemotherapy drugs. The trial was measuring two main things: how long participants lived without their cancer growing (called progression-free survival), and how long participants lived overall (overall survival). It also tracked several secondary measures, including how many participants' tumours shrank, how long that shrinkage lasted, and how participants rated their own quality of life. The reported data shows that for the primary outcomes, the median time before cancer grew or death occurred was 5.6 months in the pembrolizumab group and 5.5 months in the placebo group. The median overall survival was 15.9 months in the pembrolizumab group and 14.7 months in the placebo group. For the secondary outcomes, the proportion of participants whose tumours shrank or disappeared was reported as 29.0% in the pembrolizumab group and 27.1% in the placebo group. Among those whose tumours did respond, the reported median duration of that response was 6.3 months in the pembrolizumab group and 5.6 months in the placebo group. On the quality-of-life score (where higher numbers are better), the average change from the starting score was −0.46 in the pembrolizumab group and −2.05 in the placebo group. For the measure of how long until participants reported worsening cough, chest pain, or breathlessness, the placebo group's figure was reported as 17.97 months; the pembrolizumab group's figure was listed as "NA" (not available/not calculable) in the submitted data, meaning a comparable number was not reported for that group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03870529 · results posted 9 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 11 in a group that received a Vitamin A compound before surgery, and 9 in a group that had conventional surgery alone. All 20 participants completed the study with no dropouts. The trial was looking at whether there were differences in tissue features — specifically structures called germinal centres (small areas within tissue that are part of the immune response) and tumour cell death — between the two groups, as well as how long participants survived overall. The reported data shows that numerical results were not submitted to ClinicalTrials.gov for any of the outcome measures. This includes the primary measure (whether germinal centres were present or absent in surgically removed cancer tissue), and all three secondary measures: the proportion of germinal centres found in nearby lymph nodes, whether tumour cell death (necrosis) was present or absent, and overall survival. Because no figures were provided in the structured results, it is not possible to describe what the measurements showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03088813 · results posted 17 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03088813) ran in two parts and involved people with a type of cancer being treated with a drug called irinotecan liposome injection (a form of chemotherapy delivered in tiny fat-based particles). Part 1 enrolled 30 people and tested two different doses of the drug (85 mg/m² in 5 people, and 70 mg/m² in 25 people) to look at safety signals and early signs of how the cancer responded. Part 2 was a larger, randomised study — meaning participants were assigned by chance to one of two groups — with 229 people receiving irinotecan liposome injection at the 70 mg/m² dose and 232 people receiving a different chemotherapy drug called topotecan, for a total of 461 participants in that phase. The reported data shows the following numbers. In Part 1, all 5 people in the higher-dose group and 25 out of 25 in the lower-dose group experienced treatment-emergent adverse events (that is, unwanted medical occurrences that happened during or shortly after treatment). Serious adverse events — those considered more significant, such as requiring hospitalisation — were reported in 4 of 5 people in the higher-dose group and 9 of 25 in the lower-dose group. Events that were classified as dose-limiting (meaning side effects serious enough to potentially restrict how much of the drug could be given) occurred in 4 of 5 people at the higher dose and 2 of 25 at the lower dose. For tumour response in Part 1, the reported data shows that 40% of participants in the higher-dose group and 44% in the lower-dose group had their tumours shrink or disappear. The median time before the cancer showed signs of progressing (progression-free survival) was reported as approximately 4.2 months and 4.0 months respectively, and median overall survival (time from first dose until death from any cause) was reported as approximately 10.8 months and 8.1 months. In Part 2, the primary outcome was overall survival measured from the point of randomisation: the reported median was approximately 7.9 months for the irinotecan liposome injection group and approximately 8.3 months for the topotecan group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03840915 · results posted 21 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03840915) enrolled 70 people in total across four groups, each receiving the investigational drug bintrafusp alfa combined with a different chemotherapy regimen. The largest group (Cohort A) had 40 participants and received bintrafusp alfa with cisplatin or carboplatin and pemetrexed; Cohort B had 9 participants, Cohort C had 9, and Cohort D had 12. The trial was primarily measuring how many participants experienced "dose-limiting toxicities" — that is, serious side effects severe enough to limit how much of the treatment could be given — during the early treatment phase. It also tracked tumour response rates, how long participants went without their disease worsening (progression-free survival), how long participants lived overall (overall survival), and how long any tumour response lasted. The reported data shows that dose-limiting toxicities occurred in 1 participant in Cohort A, 1 in Cohort B, 0 in Cohort C, and 3 in Cohort D. When it came to any treatment-emergent adverse events (unwanted medical events that occurred during the treatment period), all participants in every group experienced at least one — 40 out of 40 in Cohort A, 9 out of 9 in Cohort B, 9 out of 9 in Cohort C, and 12 out of 12 in Cohort D. Serious adverse events were reported in 31 participants in Cohort A, 5 in Cohort B, 6 in Cohort C, and 9 in Cohort D. For tumour response, the reported percentages of participants whose tumours shrank to a confirmed degree were 45.0% in Cohort A, 66.7% in Cohort B, 44.4% in Cohort C, and 16.7% in Cohort D. The reported median time until disease worsening or death was 5.0 months (Cohort A), 4.1 months (Cohort B), 5.4 months (Cohort C), and 2.6 months (Cohort D). Median overall survival was reported as 11.4 months for Cohort A, 11.8 months for Cohort B, 16.5 months for Cohort D, and was not reported for Cohort C. The median duration of tumour response was 9.6 months in Cohort A, 10.5 months in Cohort C, and 3.4 months in Cohort D; this figure was not reported for Cohort B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02710396 · results posted 24 July 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people with non-small cell lung cancer (NSCLC) across two active groups: 14 participants in Cohort 1 and 5 participants in Cohort 2. Cohort 3 had no participants. The trial was measuring whether participants experienced what the researchers called "durable clinical benefit" (DCB) — meaning their disease stayed stable, shrank significantly, or disappeared entirely for longer than six months. It also tracked how many participants showed a measurable reduction in tumour size (called objective response rate), how long participants went without their disease getting worse (progression-free survival), and how long participants lived from the start of treatment (overall survival). The reported data shows that in Cohort 1, 3 out of 14 participants met the definition of durable clinical benefit, and 4 out of 14 showed a measurable tumour response. In Cohort 2, 0 out of 5 participants met the durable clinical benefit definition, and 1 out of 5 showed a measurable tumour response. No data was reported for Cohort 3 for either of these measures. For progression-free survival — the time before disease worsened — the reported median (the midpoint value for the group) was 4.80 months for Cohort 1 and 3.94 months for Cohort 2. For overall survival, the reported median was 14.06 months for Cohort 1 and 23.49 months for Cohort 2. Overall survival figures for Cohort 3 were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03626545 · results posted 22 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03626545) looked at a combination of two medicines — canakinumab and docetaxel — compared to a dummy medicine (placebo) plus docetaxel, in people with a type of lung cancer. The trial had two stages: a small safety run-in stage with 8 participants to check for serious early side effects, followed by a randomised stage where 120 people received canakinumab plus docetaxel and 117 received the placebo plus docetaxel. The trial's main goals were to record serious early side effects in the run-in stage, and then to measure how long participants in the randomised stage lived overall. The reported data shows that in the run-in stage, 1 out of 8 participants experienced what the trial defined as a dose-limiting toxicity — that is, a serious unwanted reaction occurring within the first 42 days of treatment. In the main randomised stage, the median overall survival (the point at which half the participants in each group had died) was reported as approximately 10.6 months for the canakinumab plus docetaxel group and 11.3 months for the placebo plus docetaxel group. The median time until the cancer showed signs of getting worse (progression-free survival) was approximately 4.2 months in both groups. Regarding tumour responses, about 15% of participants in the canakinumab group and 13.7% in the placebo group showed a measurable reduction in their tumour. Among those who did respond, the reported data shows the response lasted a median of around 4.1 months in the canakinumab group and 5.4 months in the placebo group. The duration of response for the run-in group was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02335944 · results posted 18 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02335944) enrolled a total of 177 participants across two phases. The first phase (Phase Ib) tested different dose combinations of two investigational drugs — INC280 and EGF816 — in 33 participants, to look at how the body tolerated different dose levels. The second phase (Phase II) enrolled participants across five groups (totalling 144 people), each defined by specific features of their lung cancer, to measure how often tumours responded to treatment, as well as tracking unwanted medical events and how consistently participants were able to take their doses. Group 5 was opened but reported zero participants enrolled. The reported data shows the following results. In the Phase Ib dose-finding stage, dose-limiting toxicities (that is, side effects serious enough within the first 28 days to affect how the dose could be given) were recorded in 1 participant at the lowest INC280/EGF816 dose combination, 0 at the next two combinations, 1 at the fourth combination, and 2 at the highest combination tested. For the Phase II groups where tumour response was measured, the reported overall response rate — meaning the percentage of participants whose tumours shrank by a defined amount or disappeared — was 28.8% in Group 1, 33.3% in Group 2, and 61.7% in Group 3. In Group 4, all 42 participants experienced at least one adverse event (an unexpected medical occurrence during the study), and 26 experienced a serious adverse event. Regarding dosing in Group 4, 30 participants had at least one INC280 dose reduction, 31 had at least one INC280 dose interruption, 12 had at least one EGF816 dose reduction, and 35 had at least one EGF816 dose interruption. No response rate data was reported for Group 5. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04081688 · results posted 2 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04081688) enrolled 16 participants, all of whom completed the study. Every participant received the same combination of three treatments: varlilumab, atezolizumab, and a type of targeted radiation called SBRT (stereotactic body radiation therapy). The main thing the trial set out to measure was how many participants experienced serious side effects — specifically, those rated Grade 3 or 4, which are considered severe or life-threatening under a standard medical grading system. The reported data shows that 2 out of 16 participants experienced Grade 3 or 4 side effects. For the secondary outcomes — which included things like how many participants' tumours responded to treatment, how long participants went without their disease getting worse, and measures of immune-related side effects — no numerical results were reported in the data submitted to ClinicalTrials.gov. This means those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02364557 · results posted 8 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02364557) enrolled 129 people in total — 68 in the standard of care (SOC) group and 61 in the standard of care plus ablation group (where ablation means a procedure to destroy tumour spots, for example using radiation or heat). The trial was looking at people with metastatic cancer (cancer that had spread) and was measuring how long participants went without their disease getting worse (called progression-free survival), as well as a number of other outcomes including the appearance of new metastases and unwanted side effects. The reported data shows that for the main Phase II measurement — the middle point of progression-free survival (the point at which half of participants had experienced disease progression or death) — participants in the standard of care group reached that point at 23.0 months, while participants in the standard of care plus ablation group reached it at 19.5 months. For the Phase III overall survival outcome, no measurements were reported in the submitted data. On secondary outcomes, the reported two-year rate of new metastases appearing was 47.7% in the standard of care group and 49.6% in the combined group. Among participants who received ablation, 45% had a recurrence or new growth in the treated area within two years. For the subset of participants whose circulating tumour cells (tiny cancer cells detectable in the blood) were tested, the two-year progression-free rate was reported as 42.3% regardless of whether those cells were present or absent. Regarding side effects, the reported data shows the number of participants experiencing adverse events (unwanted medical events) at various severity levels across both groups, but the data as submitted does not clearly separate which severity grades correspond to which counts, so a full breakdown cannot be accurately described here. The detailed adverse event information was noted as available in a separate section of the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02576574 · results posted 4 January 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02576574) enrolled 1,214 people across three groups: 366 received avelumab given every two weeks (biweekly), 322 received avelumab given every week (weekly), and 526 received chemotherapy. The trial was measuring two main things: how long participants went without their cancer growing or spreading (called "progression-free survival"), and how long participants lived overall ("overall survival"). These were looked at in participants whose tumours had higher levels of a particular protein marker called PD-L1, which was used to identify subgroups of participants. The reported data shows the following figures, expressed as median time — meaning the point at which half the participants in each group had experienced the relevant event. For progression-free survival in the high PD-L1 group, the reported median was 8.4 months for avelumab biweekly and 5.6 months for chemotherapy; and 7.5 months for avelumab weekly compared with 5.6 months for chemotherapy. For overall survival in the high PD-L1 group, the reported median was 20.1 months for avelumab biweekly and 14.9 months for chemotherapy; and 19.3 months for avelumab weekly compared with 15.3 months for chemotherapy. Secondary outcomes looking at a broader group (moderate and high PD-L1) reported progression-free survival medians of 6.9 months (avelumab biweekly) versus 5.6 months (chemotherapy), and 5.6 months (avelumab weekly) versus 5.6 months (chemotherapy). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03317496 · results posted 23 June 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 participants across two phases. The first phase (Phase 1b) involved 31 people split across four smaller groups, each receiving the immunotherapy drug avelumab at one of two doses (800 mg or 1200 mg) combined with one of two standard chemotherapy regimens (pemetrexed/carboplatin or gemcitabine/cisplatin). The main goal of this first phase was to check how many participants experienced certain serious side effects — called dose-limiting toxicities — during the first two treatment cycles, to help determine a safe dose to carry forward. The second phase then enrolled 35 participants, all receiving avelumab 1200 mg combined with gemcitabine/cisplatin, with the main goal of measuring how many participants' tumours shrank or disappeared (called an objective response). The reported data shows that in Phase 1b, dose-limiting toxicities were recorded in a small number of participants: none in the avelumab 800 mg + pemetrexed/carboplatin group, 1 out of the avelumab 800 mg + gemcitabine/cisplatin group, none in the avelumab 1200 mg + pemetrexed/carboplatin group, and 1 in the avelumab 1200 mg + gemcitabine/cisplatin group. For the tumour response measure (the primary goal of Phase 2), the reported data shows that 50% of participants in the 800 mg + pemetrexed/carboplatin group, 53.8% in the 800 mg + gemcitabine/cisplatin group, 33.3% in the 1200 mg + pemetrexed/carboplatin group, and 39% in the combined 1200 mg + gemcitabine/cisplatin group had a confirmed objective response — meaning their tumours were recorded as having shrunk or disappeared according to standard measurement criteria. Regarding adverse events (unwanted medical occurrences during treatment), the reported data shows that all participants in every group experienced at least one treatment-emergent adverse event. Serious adverse events were recorded in 3 of 6 participants in the 800 mg + pemetrexed/carboplatin group, 9 of 13 in the 800 mg + gemcitabine/cisplatin group, 5 of 6 in the 1200 mg + pemetrexed/carboplatin group, and 20 of 40 in the combined 1200 mg + gemcitabine/cisplatin group. The reported data also shows measurements of avelumab levels in the blood (how much of the drug was circulating) and tumour mutational burden (a measure of the number of genetic changes found in tumour tissue, which some researchers track as a potential marker). Blood drug levels were higher in the 1200 mg groups than in the 800 mg groups, as would be expected from a higher dose. Tumour mutational burden figures ranged from 2.5 to 4.4 mutations per megabase across the groups; however, what these figures mean in terms of patient outcomes was not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04314284 · results posted 13 June 2022
According to the results reported on ClinicalTrials.gov, this trial involved two groups of people receiving cancer treatment at a paediatric institution. One group — called the "Historical Control" group — had 69 participants, and the other — called the "I Can PIC" group — had 81 participants. The "I Can PIC" group received an educational program designed to help families understand health insurance and healthcare costs. The trial was measuring things like how well participants understood their health insurance, how "literate" they were about health insurance (meaning how confidently they could navigate it), and whether their clinical team talked to them about the costs of care. The reported data shows the following numbers. For health insurance **knowledge** (scored from 0% to 100%, where higher is better), the Historical Control group scored an average of 72.45 and the I Can PIC group scored 77.02. For health insurance **literacy** (scored from 12 to 48, where higher is better), the Historical Control group averaged 33.03 and the I Can PIC group averaged 34.71. When it came to whether a clinician discussed healthcare cost *topics* with participants, 46 people in the Historical Control group and 39 in the I Can PIC group reported this happening. For whether clinicians discussed cost-reduction *strategies*, 32 participants in each group reported this. The reported data also includes breakdowns of how many specific cost topics and strategies were discussed across both groups, with broadly similar numbers between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03904108 · results posted 26 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03904108) enrolled 3 participants, all of whom completed the study. The trial was testing a drug called ramucirumab and was looking at two main things: first, whether participants' tumours shrank or disappeared (called an "objective response"); and second, whether participants experienced side effects serious enough to cause a delay in their treatment dose or a full stop to treatment. The reported data shows that for the first main outcome — tumour shrinkage or disappearance — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the second main outcome, the reported data shows that all 3 participants experienced a treatment-related dose delay or had their treatment stopped due to side effects. It is worth noting that with only 3 participants, this was a very small study, and the numbers on their own are difficult to interpret without medical context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02750215 · results posted 14 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study. Every participant received the study drug capmatinib (also known as INC280). The trial was measuring how a tumour responded to the treatment, how long participants went without their disease getting worse, and how long participants lived overall, among other things. The reported data shows that 10% of participants had their tumours shrink enough to count as a measurable response (either the tumour disappearing completely or shrinking by at least 30%). When looking more broadly at disease control — meaning the tumour either shrank or stayed stable over 12 weeks — the reported figure was 80% of participants. For those whose tumours did respond, the reported data shows that response lasted a median (middle value in the group) of 3.8 months. When specifically looking at tumours in the brain, the reported response rate was 0%, meaning none of the participants with measurable brain tumours at the start met the criteria for a response there. The reported data also shows that the middle value for progression-free survival — the time from joining the study until the disease got worse or a participant died — was 5.5 months. The reported median overall survival, meaning the time from joining the study until death from any cause, was 11.3 months. These figures represent the midpoint of what was recorded across the group and do not predict what any individual person might experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03057106 · results posted 9 February 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03057106) enrolled 297 people in total — 149 in one group who received a combination of two immunotherapy medicines called durvalumab and tremelimumab, and 148 in a second group who received those same two medicines together with standard platinum-based chemotherapy. The trial was measuring how long participants lived overall, how long they lived before their cancer grew or spread, and how many participants' tumours shrank or disappeared. The reported data shows that, for overall survival (the time from joining the trial until death), the durvalumab-and-tremelimumab-only group had a reported median of 14.1 months, while the group who also received chemotherapy had a reported median of 16.6 months. (A "median" here simply means half the people in that group lived longer than that figure and half lived a shorter time.) For progression-free survival — how long before the cancer showed signs of growing — the reported median was 3.22 months in the immunotherapy-only group and 7.72 months in the chemotherapy-plus-immunotherapy group. Regarding tumour response, the reported data shows numbers of participants whose tumours responded in various categories across both groups, though the breakdown of specific response categories was not fully labelled in the submitted data, so a complete plain-English description of each sub-category cannot be provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02616393 · results posted 23 November 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called tesevatinib in people who had cancer that had spread to the brain or to the fluid surrounding the brain and spinal cord (called leptomeningeal metastases). A total of 36 people took part across three groups: 13 people in Cohort A (cancer that had spread to the brain), 20 people in Cohort B (cancer that had spread to the fluid around the brain and spine), and 3 people in Cohort C (cancer that had spread to the brain and was first detected there). The trial was measuring how many participants showed a reduction in their tumours, how long people went without their cancer getting worse, and how long people survived overall. The reported data shows that, for the primary goal of tumour response, 15.4% of participants in Cohort A and 100% of participants in Cohort C showed a response (meaning their tumours either shrank significantly or disappeared), giving an overall response rate of 31.3% across those two groups combined. In Cohort B, the reported response rate was 0%. For the secondary measurements, the reported median time without the cancer getting worse (called progression-free survival) was approximately 9.3 weeks for Cohort A, 10.9 weeks for Cohort B, and 37.7 weeks for Cohort C. The reported data also shows that around 47–48% of participants in Cohorts A and B were still progression-free at 12 weeks, dropping to around 26–29% at 24 weeks; for Cohort C, approximately 67% were still progression-free at 24 weeks. Regarding survival at 24 weeks, approximately 77% of Cohort A and 64% of Cohort B participants were reported to be still alive at that point. It is worth noting that Cohort C had only 3 participants, so the reported figures for that group are based on a very small number of people. No participant was recorded as having formally completed the study under the trial's completion criteria, though this was not explained further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01757288 · results posted 5 October 2021
According to the results reported on ClinicalTrials.gov, this trial involved 98 participants across its main phase (Phase II), split into two groups of 46 — one group received a chemotherapy combination including standard paclitaxel (Arm A) alongside radiation therapy, and the other received a different form of the same drug called nab-paclitaxel (Arm B), also with radiation therapy. There was also a small earlier phase (Phase I) with 6 participants used to test the nab-paclitaxel dose. The trial was primarily measuring how many participants in each group were still alive two years after starting treatment. The reported data shows that in the two-year survival measure, 66.5% of participants in the standard paclitaxel group (Arm A) and 55.5% in the nab-paclitaxel group (Arm B) were recorded as alive at the two-year mark. For progression-free survival at two years — meaning the percentage of participants who had not experienced their cancer worsening or spreading, and had not died — the reported figures were 44.4% for Arm A and 27.3% for Arm B. The reported median overall survival (the point at which half the participants in a group had died) was listed as "not available" for Arm A, and 27.8 months for Arm B. The reported data also shows that in terms of overall response rate — the proportion of participants whose cancer showed signs of shrinking — the figures were 36.8% for Arm A and 45.9% for Arm B. The reported data also included a quality-of-life measure at the start of the trial using a standard questionnaire (EQ-5D), where scores closer to 1 indicate better self-reported health. Arm A recorded a baseline score of 0.49 and Arm B recorded 0.44. In the small Phase I group, none of the 6 participants experienced the specific severe side effects that were being monitored to assess whether the treatment combination was feasible to continue studying, though this finding applies only to that early, very small group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02440139 · results posted 4 October 2021
According to the results reported on ClinicalTrials.gov, this trial involved 12 participants, all of whom completed the study with none dropping out. The trial was looking at how well clinically significant lung nodules (small spots on the lung that doctors need to act on) could be detected on CT scans — first by readers working on their own (Arm 1, the baseline), and then by readers using a computer-assisted software tool called ClearRead CT (Arm 2). The study measured detection accuracy, and also tracked how long it took readers to review each scan. The reported data shows that when readers used the ClearRead CT software, the overall number of CT-case and nodule detections recorded was 3,735, compared with 3,612 in the baseline group. The number of correctly identified nodules (a measure called sensitivity — meaning how many were actually spotted) was reported as 1,548 with the software versus 1,283 without it. The number of readings where nodules were correctly ruled out (called specificity) was 2,187 with the software compared with 2,329 without it. A separate measure called the LROC curve — which combines how accurately a nodule was both spotted and correctly located — gave a probability score of 0.773 with the software versus 0.633 without it (a score of 1.0 would mean perfect detection). For reading time, the reported data shows that scans took an average of 132.3 seconds per case with the software, compared with 98.0 seconds without it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00843726 · results posted 15 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 98 people in total — 49 in each of two groups. One group received a single high-dose session of a specialised type of targeted radiation treatment (called Stereotactic Body Radiotherapy, or SBRT), while the other group received three high-dose sessions of the same type of treatment. The trial was measuring serious side effects, how long participants lived, and whether certain markers found in blood and other samples were linked to survival or side effects. The reported data shows that when it came to serious side effects — defined as "grade 3 or higher" on a standard rating scale, meaning significant or severe reactions — 24 out of 49 participants in the single-session group and 26 out of 49 in the three-session group experienced at least one such event. For overall survival, the reported median survival (meaning the point at which half the participants in a group had passed away and half had not) was 39.0 months in the single-session group and 38.3 months in the three-session group. Regarding the third primary measure — looking at whether blood and serum markers were linked to survival or side effects — no results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02349633 · results posted 10 June 2021
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called PF-06747775 (also known as lorlatinib in some contexts, but referred to here by its study code) across multiple phases and participant groups. The trial looked at different daily doses of the drug given alone or in combination with other medicines, including palbociclib, avelumab, sildenafil, and rifampin. In total, 65 participants were enrolled across all groups in the portions of the trial that reported starting numbers. The trial was primarily measuring whether certain pre-defined serious side effects — called dose-limiting toxicities (DLTs), meaning reactions severe enough to limit how much of the drug could be given — occurred in early treatment cycles. It also measured whether tumours shrank (called an objective response) in a group receiving 200 mg of the drug daily, and how long participants went without their cancer progressing in a later phase of the trial. The reported data shows that, across the Phase 1 dose-escalation groups (doses ranging from 25 mg to 600 mg daily), zero participants out of those assessed experienced a dose-limiting toxicity in the first treatment cycle. In the group combining PF-06747775 with palbociclib (Phase 1b Cohort 2A), 2 out of 5 participants were reported to have experienced a dose-limiting toxicity. For the primary outcome measuring tumour shrinkage in the 200 mg group, the reported data shows 11 confirmed objective responses (meaning tumours that shrank by at least 30% or disappeared) out of 29 participants. For the Phase 2 portion examining progression-free survival — that is, how long participants went without their disease worsening — no numerical results were reported in the submitted data. Regarding side effects more broadly, all 29 participants in the 200 mg group reported at least one treatment-emergent adverse event (an unwanted medical occurrence during the study period), and all 29 were also recorded as having at least one treatment-related adverse event. Serious adverse events were reported in 3 of those 29 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02484443 · results posted 7 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people who received a combination treatment of two medicines — sargramostim and dinutuximab. The trial was looking at whether participants could remain free of detectable disease 12 months after joining the study, without their disease getting worse in between. Of the 41 people who started, 9 were recorded as completing the study, while 32 did not complete it. The reported data shows that 11 out of 41 participants met the definition of "12-month disease control" — meaning no detectable disease and no disease progression at the 12-month mark. The remaining participants did not meet that definition. The trial also tracked how the body processed dinutuximab over time. The reported data shows the medicine reached a peak level in the blood of 18.4 mg/L, and its overall exposure in the blood (a measure of how much of the drug was present over the entire time it was being processed) was reported as 2,136 mg-h/L. The medicine's levels in the blood dropped in two phases: a faster early phase with a half-life (the time for levels to fall by half) of 0.8 days, and a slower later phase with a half-life of 7.5 days. Separately, the trial recorded the number of treatment cycles in which a "dose-limiting toxicity" (a side effect severe enough to be considered unacceptable under the study's rules) was observed — the reported figure was 1 cycle. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01610336 · results posted 8 April 2021
According to the results reported on ClinicalTrials.gov, this two-part trial (known as Phase Ib and Phase II) tested a drug called INC280 (also known as capmatinib) in combination with gefitinib across a total of 161 participants. The participants were divided into 11 groups, each receiving different doses or forms (capsule or tablet) of INC280. The early Phase Ib part of the trial was focused on finding the right dose by looking at how often serious dose-related side effects — called "dose-limiting toxicities" — occurred. The later Phase II part measured how many participants' tumours responded to the treatment, meaning the tumour either disappeared completely or shrank by at least 30%. The reported data shows that in the Phase Ib dose-finding stage, only 1 out of the 54 Phase Ib participants experienced a dose-limiting toxicity, and that was in the group receiving 600 mg capsules twice daily. No dose-limiting toxicities were recorded in any of the other eight Phase Ib dose groups. For the Phase II stage, the reported data shows that 12 out of 53 participants in the capsule group and 17 out of 47 participants in the tablet group had a recorded tumour response (either complete disappearance of the tumour or a significant shrinkage). Regarding adverse events (unwanted health events that were recorded during the trial), the reported data shows these were noted in all participants across both phases. Serious adverse events were recorded in varying numbers across groups — for example, 12 out of 53 participants in the Phase II capsule group and 19 out of 47 in the Phase II tablet group. Dose reductions were also common, with 30 of 53 capsule-group and 23 of 47 tablet-group Phase II participants requiring a reduction in their INC280 dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03296163 · results posted 26 March 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 315 people in the MB02 group (a bevacizumab biosimilar — a medicine designed to be very similar to an already-approved drug) and 312 people in the EU-approved Avastin® group, for a total of 627 participants. The trial was measuring how the two medicines compared when given alongside chemotherapy and then on their own, in people with a condition where tumour response and survival over time were being tracked. The reported data shows that the main thing being measured — the proportion of participants whose tumours shrank or disappeared by Week 18 (called the "objective response rate") — was 40.3% in the MB02 group and 44.6% in the Avastin® group. For a secondary measure looking at how long participants went without their disease getting worse ("progression-free survival"), the reported figures were 36.0 weeks for MB02 and 37.3 weeks for Avastin®. For overall survival (how long participants lived from the start of the trial), the data was not reported for either group. The reported data also shows that 288 participants in each group experienced treatment-related side effects of some kind, and that a modest number in both groups developed antibodies against the study medicines (53 in the MB02 group and 50 in the Avastin® group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02264990 · results posted 26 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 595 people in total — 297 in a group receiving a chemotherapy treatment chosen by their doctor ("Investigator's Choice"), and 298 in a group receiving a combination of three drugs: veliparib, carboplatin, and paclitaxel. The trial was measuring how long participants lived overall, how long they lived before their cancer got worse, and how many participants' tumours shrank or disappeared. Some results were reported for all participants, and some were reported for a smaller subgroup identified by a specific biological test (called the "lung subtype panel positive" subgroup). The reported data shows the following for the biomarker-positive subgroup: the median time participants survived overall (from the point they joined the trial) was 9.2 months in the doctor's-choice group and 11.2 months in the veliparib combination group. The median time before the cancer got worse or participants died was 5.2 months versus 6.3 months respectively. The percentage of participants whose tumours shrank or disappeared was 30.0% in the doctor's-choice group and 22.5% in the veliparib combination group. For all participants combined, the reported data shows overall survival was 12.1 months in both groups. The time before cancer worsened or death was 6.7 months (doctor's choice) versus 5.9 months (veliparib combination), and tumour shrinkage or disappearance was seen in 29.0% versus 26.2% of participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01102231 · results posted 16 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people, all of whom received a combination of chemoradiotherapy (chemotherapy given alongside radiation treatment) and a medicine called cetuximab. Of those 106 participants, 91 completed the study and 15 did not. The trial was measuring how well the disease could be controlled, how many participants were still alive at 18 months, and how long participants went before their disease got worse or they passed away. The reported data shows that 89 out of 106 participants had their disease classified as "controlled" — meaning their cancer either disappeared, shrank by at least 30%, or stayed stable without growing significantly. For the secondary measures, the reported data shows that 42.4% of participants were recorded as still alive at the 18-month mark. The reported data also shows that, on average, participants went approximately 14.4 months before their disease progressed (got worse) or before death from any cause — this is referred to as "progression-free survival." It is worth noting that this was a single-group study, meaning everyone received the same treatment and there was no comparison group, so the numbers reflect only what was observed in this one group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02793856 · results posted 21 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total across four groups testing different doses of a genetically modified immune cell treatment called "PD-1 knockout T cells" for cancer. The four groups were labelled Pre-A (2 people), A (4 people), B (3 people), and C (3 people). All 12 participants who started the trial completed it. The trial's main focus was on tracking unwanted side effects and any dose-related safety signals at each dose level, using a standardised medical grading system (CTCAE v4.0). The reported data shows that the number of participants monitored for these events matched the group sizes: 2, 4, 3, and 2 respectively (noting one participant in the C group does not appear in the primary outcome count, and the data does not explain this discrepancy further). The reported data shows that when tumour responses were measured using standard imaging criteria (RECIST v1.1 — a recognised set of rules for measuring whether tumours shrink, stay the same, or grow), no participants in any of the four groups showed an overall tumour response (that is, a meaningful shrinkage). When looking at whether the disease was kept under control at 8 weeks — meaning the tumour either shrank or stayed stable — 1 person in the Pre-A group and 1 person in the B group met that measure, while no one in the A or C groups did. The reported time before the disease progressed (got worse) was 11.7 weeks for the Pre-A group, 8.0 weeks for group A, 8.1 weeks for group B, and 6.1 weeks for group C. The reported overall survival times (from first treatment to death from any cause) were 47.5 weeks, 51.4 weeks, 32.6 weeks, and 51.6 weeks for the Pre-A, A, B, and C groups respectively. Separately, blood tests looking for specific gene mutations in tumour DNA found detectable mutations in 1 participant each from the A, B, and C groups, and none in the Pre-A group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00601848 · results posted 24 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom received a treatment called Photodynamic Therapy (PDT) — a procedure that uses a light-sensitive drug and a special light source to target diseased tissue in the lining of the lung (the pleura). The trial set out to measure several things: any harmful side effects from the treatment, how long participants lived after receiving it, how long it took for the disease to progress in the pleural area specifically, how long it took for the disease to progress anywhere in the body, and how much of the PDT drug was absorbed. The reported data shows that none of the 9 participants were recorded as having completed the study, with all 9 listed under "not completed." The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — whether for side effects, survival, disease progression, or drug absorption. This means there are no figures available to describe for any of these measurements. It is not possible to say what the trial found in terms of numbers, as this information was not reported in the publicly available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT02657434 · results posted 9 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02657434) enrolled 578 adults with a form of lung cancer. Participants were split into two groups: 286 people received standard chemotherapy (carboplatin or cisplatin combined with pemetrexed), and 292 people received that same chemotherapy plus atezolizumab, an immunotherapy drug. The trial was measuring two main things — how long people lived without their disease getting worse (called progression-free survival), and how long people lived overall. The reported data shows that, for progression-free survival, the chemotherapy-only group had a median of 5.2 months before their disease progressed or they died, while the group who also received atezolizumab had a median of 7.7 months. "Median" here means the middle value — half the people in each group did better than that figure and half did worse. For overall survival, the chemotherapy-only group had a median of 13.6 months, compared with 17.5 months in the atezolizumab group. Looking at secondary measures, the reported data shows that about 55% of the chemotherapy-only group were still alive at one year, compared with about 60% in the atezolizumab group; at two years, those figures were approximately 34% and 39% respectively. Among participants whose tumours responded to treatment, the response lasted a median of 6.4 months in the chemotherapy-only group and 9.5 months in the atezolizumab group. The proportion of participants whose tumours showed a measurable response was reported as 37.4% for chemotherapy only and 51.7% for the atezolizumab group. It is worth noting that the data shows zero participants were recorded as having "completed" the study in either group, which may reflect how trial completion was defined rather than meaning no one finished treatment — however, no further explanation for this was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02147990 · results posted 12 August 2020
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called rociletinib in 317 people with a type of lung cancer. Participants were divided into three groups based on their dose (625 mg or 500 mg, taken twice daily) and whether their cancer had a specific gene change called a T790M mutation — a change that can affect how certain lung cancer treatments work. The trial's main goal was to measure how many participants saw their tumours shrink or disappear (called the "objective response rate"). The reported data shows that, for the main outcome, about 35% of participants in the 625 mg T790M-positive group and 34% in the 500 mg T790M-positive group had their tumours shrink or disappear. In the 500 mg group without the T790M mutation, this figure was lower, at 18%. For secondary outcomes, the reported data shows that the time tumours stayed reduced (duration of response) ranged from around 7.4 to 9.1 months across groups. The time until the disease started growing again or participants passed away (progression-free survival) was reported as approximately 5.5 to 5.9 months, while overall survival — the time from first dose until death from any cause — was reported as approximately 18.8 months for the 625 mg group, 29.8 months for the 500 mg T790M-positive group, and 23.7 months when both T790M-positive groups were combined. A measure of disease control (tumours shrinking, disappearing, or staying stable for at least 12 weeks) was reported at 67.3%, 76.3%, and 59.0% for the three groups respectively. Quality-of-life scores on a standard 0–100 questionnaire (where higher means better) started between roughly 55 and 62 at the beginning of the trial and showed small changes over time across groups, with some decline reported by the end of treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02713867 · results posted 22 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02713867) enrolled 363 people in total — 180 in the nivolumab 480 mg group and 183 in the nivolumab 240 mg group. The trial was comparing two different doses of the drug nivolumab and measuring how many participants went a certain period of time without their cancer getting worse (called "progression-free survival") and how many were still alive at set points in time. The reported data shows the following figures for the proportion of participants whose cancer had not progressed and who were still alive at various time points. At 6 months, the figure was 0.76 (roughly 76 in every 100 participants) in the 480 mg group and 0.79 (roughly 79 in every 100) in the 240 mg group. At 12 months, those figures were 0.53 and 0.55 respectively. At 24 months, the reported data shows 0.34 in the 480 mg group and 0.35 in the 240 mg group. For overall survival — meaning the proportion of participants still alive — at 12 months, the reported figures were 0.851 (about 85 in every 100) in the 480 mg group and 0.908 (about 91 in every 100) in the 240 mg group. Additional breakdowns by tumour type and by how well tumours had responded to treatment were also reported, with figures generally in a similar range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02289690 · results posted 14 May 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02289690) had two parts. The first part (Phase 1) enrolled 40 people across seven groups, each receiving the investigational drug veliparib twice daily at different doses (80 mg up to 240 mg) combined with two chemotherapy medicines, carboplatin and etoposide. The second part (Phase 2) enrolled 181 people across three groups, comparing veliparib combined with those same chemotherapy medicines against a placebo (a dummy treatment with no active ingredient). The trial was measuring how the drug behaved in the body at different doses, whether certain serious side effects (called dose-limiting toxicities — meaning reactions severe enough to prevent continuing or delay treatment) occurred, and other outcomes in the Phase 2 portion. The reported data shows that in Phase 1, across most dose groups no participants experienced a dose-limiting toxicity. One participant out of eight in the 240 mg twice-daily, 7-day group, and one participant out of four in the 240 mg twice-daily, 21-day group, were reported to have experienced such a toxicity. The reported data also tracked how much veliparib was measured in participants' blood. The peak blood level of veliparib rose from 0.620 micrograms per millilitre at the lowest dose to 1.99 micrograms per millilitre at the highest dose tested. The time it took to reach that peak level ranged between 1 and 2 hours across dose groups. Measures of the total amount of drug in the blood over time also increased with higher doses. When these blood levels were adjusted to account for the different dose sizes, the values were broadly similar across all dose groups, ranging from about 7.19 to 8.66 units, suggesting the drug's behaviour in the body scaled broadly in line with dose. Outcome data for the Phase 2 portion of the trial was not reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02818920 · results posted 18 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received the drug pembrolizumab both before and after surgery for their condition. The trial was primarily measuring what researchers called "surgical feasibility" — that is, whether patients who received at least one dose of pembrolizumab were able to go ahead with surgery within a specific window of time (between 29 and 56 days after starting the drug). Of the 30 people who started the study, 25 went on to have surgery, 17 received the follow-up (adjuvant) treatment after surgery, and 12 completed the full study. Eighteen participants did not complete the study, though the reasons were not detailed in the data provided here. The reported data shows that 24 out of 30 participants met the definition of "surgically feasible" — meaning they received at least one dose of pembrolizumab and had their surgery within the required timeframe. Several other outcomes were also planned to be measured, including how tumours responded to treatment, how long participants remained free of disease after surgery, changes in certain biological markers in the blood, the presence of particular immune cells in tumour tissue, and any unwanted side effects. However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these additional measures, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02481830 · results posted 9 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02481830) enrolled 569 people in total — 284 in Group A and 285 in Group B. The trial was measuring how long participants lived overall, how long it took for their condition to worsen or progress, and what proportion of participants saw their tumours shrink or disappear. Participants went through a pre-treatment period before moving into the treatment period of the trial. The reported data shows the following figures. For overall survival — that is, the time from when someone joined the trial until death — the median (the midpoint value, where half of participants fell above and half below) was 7.46 months for Group A and 8.38 months for Group B. For progression-free survival — the time until the condition was recorded as getting worse or until death — the reported median was 1.45 months for Group A and 3.71 months for Group B. For objective response rate — the percentage of participants whose tumours were recorded as having shrunk by a meaningful amount or disappeared entirely — the reported figures were 13.7% in Group A and 16.8% in Group B. An additional analysis using extended data collection reported the same overall survival figures of 7.46 months and 8.38 months for Group A and Group B respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT01526928 · results posted 6 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01526928) enrolled a total of 612 participants across six treatment groups, all receiving different doses or formulations of a drug called rociletinib. The trial had two phases: a smaller Phase 1 portion (around 91 participants) focused on finding safe dose levels, and a larger Phase 2 portion (around 501 participants) that looked at how tumours responded to the drug. All participants had a specific genetic change in their cancer called a T790M mutation, which is linked to a type of lung cancer that has stopped responding to earlier treatments. The reported data shows that, among participants with the T790M mutation, the number whose tumours shrank to a qualifying degree (either partially or completely) ranged from 3 to 72 people depending on which dose group they were in. For those whose tumours did respond in this way, the length of time that response lasted ranged from approximately 217 days to 428 days across the different dose groups. Regarding how long participants lived overall (from first dose to death from any cause), the reported figures ranged from about 7.2 months to 23.7 months across the groups. The length of time before the disease worsened or participants died (called progression-free survival) ranged from approximately 2.6 months to 10.4 months across the groups. In the Phase 1 dose-finding portion, the number of participants who experienced a "dose-limiting toxicity" (a side effect serious enough to cap the dose) was 1 to 2 people per dose group. Some pharmacokinetic measurements (how much drug was detected in the blood) were also reported, but not all dose groups had full data recorded for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03371381 · results posted 11 December 2019
According to the results reported on ClinicalTrials.gov, this Phase 1b clinical trial enrolled 12 participants, all of whom received a combination of two investigational treatments: JNJ-64041757 (a type of immunotherapy) and nivolumab (another immunotherapy drug). The trial was primarily measuring whether participants' tumours shrank or disappeared — known as an "objective response" — and also tracked how long any response lasted, whether the disease progressed or participants died, and what medical events occurred during treatment. Notably, none of the 12 participants were recorded as having completed the study. The reported data shows that the primary outcome — the percentage of participants whose tumours shrank or disappeared — was 0%, meaning none of the 12 participants met the criteria for a complete or partial tumour response. For the secondary outcomes, the reported data shows that 10 out of 12 participants experienced disease progression or died before progression, and 5 out of 12 participants died during the study period. No figures for the duration of response were reported in the data, as no participants had achieved a response to measure. All 12 participants experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that happened after starting treatment). Additionally, 1 participant had a blood culture that tested positive for listeriosis (a bacterial infection that was specifically monitored as part of the trial). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02453282 · results posted 29 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02453282) enrolled 1,118 people with lung cancer across three groups: 374 received durvalumab alone, 372 received durvalumab combined with tremelimumab, and 372 received standard chemotherapy. The trial was primarily measuring two things: how long participants lived overall (called "overall survival"), and how long they went without their disease getting worse (called "progression-free survival"), focusing especially on participants whose tumours had a certain level of a protein marker called PD-L1. The reported data shows that, among participants with higher PD-L1 levels (at least 25% of tumour cells testing positive), the median overall survival — that is, the midpoint time at which half the participants in each group had died — was 16.3 months for the durvalumab-alone group, 11.9 months for the durvalumab-plus-tremelimumab group, and 12.9 months for the standard chemotherapy group. For progression-free survival in that same higher PD-L1 group, the reported median was 3.9 months for the combination group compared with 5.4 months for chemotherapy. When looking at the full study population regardless of PD-L1 levels, the reported median overall survival figures were 12.3 months, 11.2 months, and 11.8 months for the three groups respectively. The reported data also notes that no participants were recorded as having "completed" the study, meaning all participants either stopped early or were still being followed at the time the data was recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02221739 · results posted 22 November 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people with advanced (metastatic) non-small cell lung cancer. All participants received a combination of the drug ipilimumab (a type of immunotherapy) and radiotherapy (radiation treatment). The trial was primarily looking at how tumours responded to this combination, by measuring whether tumours shrank or disappeared — not including the specific area that was directly treated with radiation. Of the 39 who started, 21 completed the study and 18 did not. The reported data shows that out of 39 participants, 7 had a measurable tumour response (meaning their tumours either partially shrank or completely disappeared in areas outside the treated site). The trial also included a secondary measurement looking at immune system changes in the blood — specifically tracking certain immune cells (called T-cells) thought to play a role in fighting cancer. The reported data shows that 7 participants showed an objective response under this measure, with 2 and 5 participants recorded across two sub-categories of that measure. It is worth noting that the detailed breakdown of what those two sub-figures specifically represent was not fully explained in the submitted data. It is important to understand that these numbers describe what was observed in this particular group of trial participants — they do not tell us whether the treatment works or is safe, and they cannot be used to predict outcomes for anyone else. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03780010 · results posted 28 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03780010) enrolled 15 people in total across two groups. Three participants received a lower dose of an experimental drug called TRC105 (8 mg/kg) combined with two other medicines — bevacizumab and a chemotherapy pair (paclitaxel and carboplatin). Twelve participants received a higher dose of TRC105 (10 mg/kg) with the same combination. The trial was primarily measuring how many participants experienced side effects or unwanted events linked to the treatment, and also looked at how tumours responded and how long participants went without their disease progressing. The reported data shows that in the lower-dose group, all 3 participants experienced treatment-related adverse events (unwanted health events that occurred during the study). In the higher-dose group, the reported numbers across different categories of adverse events ranged from 10 to 12 out of 12 participants. For tumour response — meaning whether tumours shrank or stayed stable — the reported data shows that in the lower-dose group, 2 out of 3 participants had some measurable response, while in the higher-dose group, 9 out of 12 did. Regarding how long participants went without their disease getting worse, the reported middle-point figure (called the median) was 3 months in the lower-dose group and 6.5 months in the higher-dose group. At the 6-month mark specifically, 1 out of 3 participants in the lower-dose group and 7 out of 12 in the higher-dose group had not yet had their disease progress. The reported data also shows that blood levels of TRC105 were higher in the higher-dose group, as would be expected, and that 1 participant in the higher-dose group developed antibodies against TRC105 (meaning their body produced a response to the drug itself), while none did in the lower-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02538666 · results posted 22 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 907 participants across three groups: 300 received a placebo (a dummy treatment), 304 received nivolumab alone (at a dose of 240 mg), and 303 received a combination of nivolumab (1 mg/kg) and ipilimumab (3 mg/kg). The trial was measuring how long participants lived overall (called "overall survival"), as well as how long they lived without their disease getting worse (called "progression-free survival" — meaning the time before the cancer showed signs of growing or spreading). Results were tracked both for a global group of participants and separately for participants enrolled in China. The reported data shows that for the primary measure — overall survival comparing the combination of nivolumab plus ipilimumab against placebo in the global group — the median time participants survived was 9.17 months in the combination group and 9.56 months in the placebo group. (Median means half the participants in each group survived longer than this figure, and half did not reach it.) For the secondary comparison of nivolumab alone versus placebo in the global group, the reported median overall survival was 10.18 months for nivolumab and 9.56 months for placebo. In the China subgroup, those figures were 8.18 months for nivolumab and 9.28 months for placebo. For progression-free survival globally, the reported median was approximately 1.94 months for nivolumab alone, 1.74 months for the combination, and 1.41 months for placebo. The reported data also shows results broken down by something called "tumour mutational burden" (TMB) — a measure of how many genetic changes are present in a tumour. Among participants with higher TMB (≥13 mutations per megabase), reported median overall survival was 12.98 months for nivolumab alone, 13.47 months for the combination, and 9.69 months for placebo. Among those with lower TMB in the same cutoff group, figures were 9.89, 7.85, and 10.02 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01822496 · results posted 5 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 59 people in total across four groups. Participants had lung cancer with specific genetic markers — either an EGFR mutation or an ALK gene change — and were assigned to receive a targeted drug (erlotinib for the EGFR group, crizotinib for the ALK group) or no targeted drug, alongside their other treatment. The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as tumour response rates, overall survival, and certain side effects. Importantly, the trial closed earlier than planned, so the researchers noted that no formal statistical comparisons were carried out. The reported data shows the following numbers for how long, on average, participants went without their cancer progressing: in the EGFR group, those who received erlotinib had a reported median of 21.1 months, compared with 9.2 months for those who did not; in the ALK group, those who received crizotinib had a reported median of 14.7 months, while a figure for the ALK "no crizotinib" group was not reported. For tumour response (the percentage of people whose tumours shrank to a defined degree), the reported figures were 50% in the EGFR erlotinib group, 26.7% in the EGFR no-erlotinib group, 66.7% in the ALK crizotinib group, and 75% in the ALK no-crizotinib group. For overall survival, a median of 35.9 months was reported only for the EGFR no-erlotinib group; figures for the other three groups were not reported. Regarding serious side effects (graded as severe, life-threatening, or fatal), the reported data shows zero participants in any of the four groups experienced these during the study period. The reported data also shows figures for how long participants went without cancer progressing locally or spreading to distant parts of the body, though several of these figures were listed as not available for certain groups. Because the trial ended early with relatively small numbers, these results should be interpreted with particular caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02763579 · results posted 13 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 513 people in total. The global part of the trial included 202 people who received a placebo plus two chemotherapy drugs (carboplatin and etoposide), and 201 people who received a medicine called atezolizumab plus the same two chemotherapy drugs. A separate China-only part of the trial included 53 and 57 people in those same two groups respectively. The trial was measuring two main things: how long people lived without their disease getting worse (called progression-free survival), and how long people lived overall (called overall survival). The reported data shows that, in the global group, people in the placebo-plus-chemotherapy group went a median (the middle value in a range) of 4.3 months before their disease progressed, while those in the atezolizumab-plus-chemotherapy group went a median of 5.2 months. For overall survival, the reported median was 10.3 months in the placebo group and 12.3 months in the atezolizumab group. Looking at secondary outcomes, the reported data shows that around 76.7% of people in the placebo group and 74.1% in the atezolizumab group had their tumour shrink or disappear at some point. Among those whose tumour did respond, the response lasted a median of 3.1 months in the placebo group and 4.1 months in the atezolizumab group. At six months, about 22% of the placebo group and 31% of the atezolizumab group were still alive without their disease worsening; at one year those figures were about 5% and 13% respectively. For overall survival at one year, approximately 38% of the placebo group and 52% of the atezolizumab group were reported to be alive; two-year overall survival figures were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02352948 · results posted 16 April 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02352948) enrolled 595 people across two sub-studies looking at treatments for cancer. Sub-study A compared the immunotherapy drug durvalumab (62 people) against standard-of-care treatment (64 people). Sub-study B compared four groups: durvalumab combined with another immunotherapy called tremelimumab (174 people), standard-of-care (118 people), durvalumab alone (117 people), and tremelimumab alone (60 people). The trial was primarily measuring how long participants lived overall ("overall survival") and how long they lived before their disease got worse ("progression-free survival"). The reported data shows the following numbers for overall survival — meaning the middle point at which half the participants in each group had died and half had not (called a median, measured in months): In Sub-study A, the durvalumab group recorded 11.7 months compared to 6.8 months in the standard-of-care group. In Sub-study B, the durvalumab-plus-tremelimumab group recorded 11.5 months compared to 8.7 months for standard-of-care; durvalumab alone recorded 10.0 months and tremelimumab alone recorded 6.9 months. For progression-free survival, the reported medians were: Sub-study A — 3.8 months (durvalumab) versus 2.2 months (standard-of-care); Sub-study B — 3.5 months for both the combination group and standard-of-care, 3.1 months for durvalumab alone, and 2.1 months for tremelimumab alone. The reported data also shows that, at the 12-month mark, the percentage of participants estimated to still be alive was: 49.3% (Sub-study A durvalumab) versus 31.3% (Sub-study A standard-of-care); and in Sub-study B, 49.5% (combination), 38.8% (standard-of-care), 43.6% (durvalumab alone), and 41.2% (tremelimumab alone). For the proportion of participants whose tumours shrank by a meaningful amount (called the objective response rate), the reported figures were: 35.5% for Sub-study A durvalumab versus 12.5% for standard-of-care; and in Sub-study B, 14.9% (combination), 6.8% (standard-of-care), 15.4% (durvalumab alone), and 6.7% (tremelimumab alone). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00614822 · results posted 20 March 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom received the same treatment combination — carboplatin, bevacizumab, and pemetrexed — meaning there was no comparison group or placebo. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), how long participants lived overall ("overall survival"), how many participants' tumours shrank or disappeared, and how many participants experienced serious unwanted effects. The reported data shows that the median time without disease progression was 28 weeks, and the median overall survival — that is, the midpoint for how long participants lived from the start of treatment — was 49 weeks. These "median" figures mean that half of participants fell above that number and half fell below. Of the 50 people who started the trial, 47 completed it and 3 did not. Looking at tumour responses, the reported data shows that 1 participant had a complete response (all detectable tumour disappeared) and 27 participants had a partial response (tumours shrank by at least 30%). Regarding unwanted effects, the reported data shows that 1 participant each experienced a grade 4 (severe) toxic reaction, a hospitalisation due to toxicity, a fever with low white blood cell counts, and a clinically significant bleeding or clotting event — though it is not stated whether these were the same or different participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00480025 · results posted 30 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00480025) enrolled 2,272 participants in total — 1,515 received an investigational treatment called GSK1572932, and 757 received a placebo (an inactive substance used for comparison). The trial was studying people who had been treated for non-small cell lung cancer, and it was measuring two main things: how long participants went without their cancer coming back or dying (called "disease-free survival"), and how long participants overall survived. Some participants had also received chemotherapy alongside the study treatment, and results were reported separately for those subgroups. The reported data shows that the main way results were expressed was as a rate of events (cancer returning or death) per person-year — meaning, roughly how often these events occurred across the total time all participants were followed. For disease-free survival across all participants, the GSK1572932 group had a reported rate of 0.17 events per person-year, compared with 0.168 in the placebo group. In the subgroup who did not receive chemotherapy, the reported rates were 0.169 (GSK1572932) versus 0.178 (placebo). In the subgroup who did receive chemotherapy, the reported rates were 0.172 (GSK1572932) versus 0.158 (placebo). For overall survival across all participants, the reported rates were 0.082 (GSK1572932) versus 0.081 (placebo), with similarly close figures seen in both chemotherapy subgroups. The reported data shows that in all comparisons, the numbers between the GSK1572932 group and the placebo group were very close to one another. It is also worth noting that a large proportion of participants in both groups did not complete the study — 752 of the 1,515 in the GSK1572932 group and 369 of the 757 in the placebo group — though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02125461 · results posted 30 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02125461) enrolled 713 people in total — 476 received durvalumab (also known as MEDI4736) and 237 received a placebo (an inactive treatment used for comparison). The trial was measuring two main things: how long participants went without their disease getting worse (called progression-free survival), and how long participants lived overall (called overall survival). Several secondary measures were also tracked, including how many participants' tumours shrank, how long those responses lasted, and what proportion of participants were still alive and progression-free at 12 and 18 months after joining the trial. The reported data shows that, for progression-free survival, the median time without disease worsening was 16.8 months in the durvalumab group compared with 5.6 months in the placebo group. (Median means the point at which half the participants had experienced that outcome and half had not.) For overall survival, the median had not yet been reached in the durvalumab group at the time of reporting — meaning enough participants in that group had not yet died for a midpoint to be calculated — while the placebo group's median overall survival was reported as 28.7 months. Regarding tumour shrinkage (objective response rate), 30.0% of the durvalumab group and 17.8% of the placebo group were reported to have had their tumours shrink by a meaningful amount. For how long those responses lasted, the median duration had not been reached in the durvalumab group, while it was 18.4 months in the placebo group. At 12 months, 55.9% of the durvalumab group and 35.3% of the placebo group were reported to be alive and progression-free; at 18 months, those figures were 44.2% and 27.0% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02875340 · results posted 15 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02875340) enrolled 8 participants, all of whom received a treatment called VAL401 — a formulation of risperidone being investigated in the context of cancer. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as quality of life, tumour response, and how the drug moved through the body in the bloodstream. Notably, the reported data shows that none of the 8 participants were recorded as having completed the trial; all 8 were listed as "not completed." The reported data shows that, on average, participants in the "intention to treat" group (all enrolled participants) went 5.2 weeks before disease progression or withdrawal, while those in the "per protocol" group (those who followed the study plan most closely) reached 7.2 weeks. When looking at tumour measurements, 2 participants showed a partial response (meaning their tumours shrank by at least 30%), 2 had stable disease (neither meaningful shrinkage nor growth), and 2 were not evaluable — no complete disappearances of tumours were recorded. On the question of quality of life, changes were tracked across several areas using a standard cancer questionnaire, though the reported data presents only participant counts across categories rather than a single overall score, making a simple summary difficult to convey. Regarding adverse events (unwanted health effects during the trial), the reported data shows that all 8 participants experienced at least one adverse event, 1 participant had a serious adverse event, and 7 had adverse events that were not classified as serious. The reported data also includes measurements of how much of the drug was detected in participants' blood. Peak blood levels of VAL401 on the first day of treatment averaged 30.5 ng/mL (nanograms per millilitre, a measure of drug concentration), and by day 15, peak levels varied depending on the dose received — ranging from 20 ng/mL at the lowest dose (2 mg) up to 464 ng/mL at the highest dose (8 mg). The lowest blood levels recorded (the "trough," meaning the amount remaining just before the next dose) followed a similar pattern across dose levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00298896 · results posted 26 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people, all of whom received a treatment called SNS-595. The trial was measuring how tumours responded to this treatment, using a standardised set of scanning-based rules called RECIST criteria — essentially, doctors used CT or MRI scans to measure whether tumours shrank, stayed the same, or grew. Only 5 of the 55 participants completed the study, while 50 did not complete it (the reasons were not detailed in the reported data). The primary thing the trial was tracking was the "objective response rate" — meaning how many participants had their tumours shrink by a meaningful amount or disappear entirely based on the scan measurements. The reported data shows that 3 out of 55 participants met this threshold for a response. For the secondary measure — the "best overall response," meaning the best result each person achieved at any point during treatment — the reported data shows 1 participant had a complete response (all target tumours disappeared on scans), 2 had a partial response (tumours shrank by at least 30%), 31 had stable disease (tumours neither shrank enough to count as a response nor grew enough to count as progression), and 13 had progressive disease (tumours grew). The remaining participants' best responses were not reported in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01901653 · results posted 11 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01901653) tested an experimental drug called rovalpituzumab tesirine in people with two types of lung cancer — small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). A total of 82 people took part across multiple groups. The trial was an early-phase (Phase 1) study, meaning its main purpose was to find the highest dose of the drug that could be given without causing too many serious side effects, and to gather initial information on how tumours responded. Participants were divided into different groups that received different doses or treatment schedules, and none of the participants were recorded as having completed the study in the way the trial defined "completion." The reported data shows that the highest dose identified before serious side effects became too common — known as the Maximum Tolerated Dose — was 0.4 mg/kg. For the secondary measurements, investigators assessed how many participants' tumours shrank (called the Objective Response Rate, or ORR): roughly 25% of SCLC participants showed a meaningful tumour shrinkage according to the treating doctors' assessments, while 0% of LCNEC participants did. A broader measure — called Clinical Benefit Rate, which also counts people whose disease stayed stable — was reported at around 73% for SCLC participants and 88% for LCNEC participants in one assessment category. The reported data shows that for SCLC participants, the average time before the disease worsened (progression-free survival) was approximately 2.79 months, and the average overall survival was approximately 4.76 months. For LCNEC participants, those figures were approximately 3.07 months and 6.59 months respectively. Among those whose tumours did respond, the response lasted a median of approximately 2.89 months for SCLC participants; no duration of response data was reported for LCNEC participants, as no responses were recorded in that group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02364999 · results posted 27 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 358 people in the PF-06439535 group and 361 people in the Bevacizumab-EU group — a total of 719 participants. The trial was comparing these two medicines (PF-06439535 is a proposed biosimilar version of bevacizumab, a cancer medicine) to see whether they produced similar results. The main thing being measured was how many participants' tumours shrank or disappeared by around Week 19 of the study, with that response then confirmed by around Week 25. The reported data shows that, for the primary measure (the proportion of participants whose tumours shrank or disappeared), the figure was 45.3% in the PF-06439535 group and 44.6% in the Bevacizumab-EU group. For secondary measures, the reported data shows that among those whose tumours did respond, the response lasted a median of 36.3 weeks in the PF-06439535 group and 28.7 weeks in the Bevacizumab-EU group. At 55 weeks, an estimated 32.3% of the PF-06439535 group and 30.5% of the Bevacizumab-EU group had not experienced their disease progressing. Estimated survival at 55 weeks was reported as 65.8% for the PF-06439535 group and 64.1% for the Bevacizumab-EU group. Regarding unwanted medical events that occurred during treatment, the reported data shows these were recorded in 344 of 356 participants who received PF-06439535 and 347 of 358 who received Bevacizumab-EU. Serious unwanted events were recorded in 190 participants in the PF-06439535 group and 199 in the Bevacizumab-EU group. Laboratory test abnormalities were noted in 303 and 304 participants respectively. The trial recorded these numbers but drawing any conclusions about what they mean requires medical expertise. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01970865 · results posted 29 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01970865) involved a study of a drug called PF-06463922 (lorlatinib) and was conducted in two phases. The first phase tested different dose levels — ranging from 10 mg once daily up to 200 mg once daily, and several twice-daily doses — to look at how the drug behaved at each level and to identify any serious side effects known as "dose-limiting toxicities" (unwanted reactions severe enough to limit the dose). The second phase enrolled participants across six different groups (EXP-1 through EXP-6), each representing people with different cancer backgrounds or treatment histories. In total, across all groups in both phases, 364 people started the trial. The reported data shows that in Phase 1, only one participant (in the 200 mg once-daily group) experienced a dose-limiting toxicity during the first treatment cycle; no dose-limiting toxicities were reported in any other dose group. For Phase 2, the percentage of participants whose tumours showed an overall response (meaning tumours shrank or disappeared based on scans reviewed by an independent team) ranged from around 35% to 90% depending on the group — with EXP-1 reporting the highest figure of 90% and EXP-5 the lowest at approximately 35%. When looking only at tumour changes inside the brain (intracranial response), the reported figures ranged from approximately 40% to 75% across the six Phase 2 groups. In Phase 1, among participants with a particular genetic marker (ALK-positive), around 39% showed an overall tumour response, while among those with another marker (ROS1-positive), around 50% did. The reported data shows that for those who did respond in Phase 1, the time from first dose to first recorded response was approximately 1.4 months in both genetic marker groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01395758 · results posted 3 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01395758) enrolled 96 people with a specific type of lung cancer (non-small cell lung cancer, or NSCLC) that had a particular gene change called a KRAS mutation. Participants were split into two main groups: 51 people received a combination of two drugs called tivantinib and erlotinib, and 45 people received standard chemotherapy. A separate group of 26 people later crossed over to receive the tivantinib plus erlotinib combination after their initial treatment. The trial was primarily measuring how long people went without their cancer growing or spreading (called "progression-free survival"), and also looked at how long people lived overall and how many people's tumours shrank. The reported data shows that, for the main measure — time without the cancer progressing — the tivantinib plus erlotinib group went a median (the middle value in the group) of 7.3 weeks, compared to 18.6 weeks in the chemotherapy group. For overall survival (time from the start of the trial until death from any cause), the reported median was 6.8 months in the tivantinib plus erlotinib group and 8.5 months in the chemotherapy group. When looking at how many people's tumours shrank or disappeared (called the objective response rate), the reported data shows 0 out of 51 participants in the tivantinib plus erlotinib group had this response, compared to 4 out of 45 in the chemotherapy group. Among the 26 people who crossed over to the tivantinib plus erlotinib combination later, 2 participants had their tumours shrink or disappear. It is worth noting that the data as submitted does not include additional detail such as the total number of participants assessed for each response measure, so some context around those figures was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00324805 · results posted 14 February 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,501 people with early-stage non-small cell lung cancer (a type of lung cancer that had been surgically removed). Participants were randomly assigned to one of two groups: 749 people received chemotherapy alone, and 752 people received chemotherapy plus an additional medicine called bevacizumab. The trial was primarily measuring how long people lived overall after joining the study, and also tracking how long they went without their cancer returning or a new cancer appearing. The reported data shows that for the main measure — overall survival (how long participants lived) — a result was only reported for the chemotherapy-plus-bevacizumab group, at 85.8 months (roughly seven years). A comparable figure for the chemotherapy-alone group was not reported in the data submitted to ClinicalTrials.gov. Importantly, the trial itself noted that it did not meet its primary goal. For the secondary measure — how long people went without their cancer coming back or a new cancer appearing — the chemotherapy-alone group recorded 42.9 months and the chemotherapy-plus-bevacizumab group recorded 40.6 months. Results for the planned analyses around side effects, tissue and blood markers, and smoking status were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01025284 · results posted 4 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 64 participants across three groups. Part A included 38 people who received a dose of 8 mg/m² per day of the study drug. Part B included 26 people split across two dose levels — 18 people received 5 mg/m² per day and 8 people received 6 mg/m² per day. All participants who started the trial received at least one dose of the study drug. The trial was measuring how tumours responded to the study drug, using standard imaging-based criteria to track whether tumours shrank, stayed stable, or grew. The reported data shows that in Part A, 2.6% of participants had their tumours either disappear completely or shrink by at least 30% (called the "overall response rate"). When stable disease — meaning tumours neither shrank enough to count as a response nor grew enough to count as progression — was also included, 23.7% of Part A participants fell into this broader "clinical benefit" category. The reported median time from starting treatment until disease progression or death in Part A was 5.3 weeks. For Part B, the reported data shows that 0% of participants achieved a complete or partial tumour shrinkage response, while 26.9% met the broader clinical benefit measure (including stable disease). The median progression-free time in Part B was reported as 6.1 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01966003 · results posted 19 October 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01966003) compared two medicines — ABP 215 and bevacizumab — in 328 and 314 participants respectively (642 people in total). ABP 215 is a "biosimilar", meaning it is designed to be a very close copy of bevacizumab, which is an existing medicine. The trial was measuring whether the two medicines produced similar results across several areas, including how many participants' tumours shrank or disappeared, how long that response lasted, how long participants went without their disease getting worse, and how long participants survived overall. The reported data shows that 39.0% of participants in the ABP 215 group had an objective response (meaning their tumour either shrank significantly or disappeared completely), compared with 41.7% in the bevacizumab group. For those who did respond, the reported duration of that response was 5.8 months in the ABP 215 group and 5.6 months in the bevacizumab group. The time participants went without their disease getting worse (called progression-free survival) was reported as 6.6 months for ABP 215 and 7.9 months for bevacizumab. Overall survival figures were not reported in the submitted data. Regarding unwanted health events during the trial, 308 out of 324 participants in the ABP 215 group and 289 out of 309 in the bevacizumab group recorded at least one adverse event (an unwanted health change noted during the study). A small number of participants developed antibodies against the study drugs — 4 in the ABP 215 group and 7 in the bevacizumab group — though none were found to be the neutralising (blocking) type in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01828099 · results posted 21 September 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01828099) enrolled 376 participants — 189 in the ceritinib group and 187 in the chemotherapy group. The trial was measuring how long people went without their cancer getting worse (called "progression-free survival"), as well as several other things: how long people lived overall, how many people's tumours shrank or disappeared, and how long those responses lasted. Some participants in the chemotherapy group later crossed over to receive ceritinib in an extension phase of the trial. The reported data shows that, for the main measure — time without disease progression as assessed by an independent review committee — the ceritinib group had a median of 16.6 months, compared with 8.1 months in the chemotherapy group. (Median means half the participants in each group had results above this figure and half below.) For overall survival — that is, how long people lived from the start of the trial — the reported median figures were 62.9 months for the ceritinib group and 40.7 months for the chemotherapy group. The reported data also shows that the proportion of participants whose tumours shrank meaningfully (by independent review) was 72.5% in the ceritinib group and 26.7% in the chemotherapy group, with similar figures seen when the treating doctors did their own assessments. Among those who did respond, the reported median duration of that response (by independent review) was 23.9 months for ceritinib and 11.1 months for chemotherapy. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02695290 · results posted 18 September 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02695290) enrolled only one participant, who received the study drug afatinib. The trial was primarily measuring how often participants needed to have their dose of afatinib reduced because of unwanted side effects (called adverse events). It also looked at whether participants experienced certain severe side effects — specifically serious diarrhoea, skin rash or acne, mouth sores, or nail problems — rated at a level of "grade 3 or higher" (meaning severe or worse on a standard medical scale). A third measurement tracked how long it took before any dose reduction was needed. The reported data shows that, for the single participant in this trial, 0% of participants had their afatinib dose reduced due to side effects. Similarly, the reported data shows that 0% of participants experienced any of the severe side effects being tracked (serious diarrhoea, rash/acne, mouth sores, or nail problems). Regarding the time until a first dose reduction was needed, the data was not reported for this outcome measure. It is worth noting that with only one person enrolled, these numbers are extremely limited and cannot be used to draw broader conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02151981 · results posted 21 July 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02151981) enrolled 279 people in the osimertinib 80 mg group and 140 people in the chemotherapy group. The trial was measuring how long people with a certain type of lung cancer lived without their disease getting worse (called "progression-free survival"), as well as a number of other outcomes including how many people's tumours shrank, how long those responses lasted, and how long people lived overall. The reported data shows that, for the main outcome — the time from starting treatment until the disease got worse or the person died — the osimertinib group had a reported median of 10.1 months, compared with 4.4 months in the chemotherapy group. (Median means half the people in that group reached that point before this time, and half after.) For the secondary outcomes, the reported data shows that 70.6% of people in the osimertinib group and 31.4% in the chemotherapy group had their tumour shrink by a meaningful amount at some point during the trial. Among those whose tumours did shrink, that reduction lasted a reported median of 9.7 months in the osimertinib group and 4.1 months in the chemotherapy group. When looking at tumour size change from the start of the trial, the osimertinib group's tumours were reported to have shrunk by an average of 46.1%, compared with 24.4% for chemotherapy. The proportion of people whose disease at least stabilised (did not grow significantly) was reported as 93.2% for osimertinib and 74.3% for chemotherapy. Finally, the reported median overall survival — how long people lived from the start of the trial — was 26.8 months in the osimertinib group and 22.5 months in the chemotherapy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00856830 · results posted 17 July 2017
According to the results reported on ClinicalTrials.gov, this trial involved 30 people in total across four groups. The first three groups (15 people) were part of a Phase I dose-finding stage, where researchers gave participants a drug called Bendamustine combined with Irinotecan at increasing doses to find the highest dose that could be given without causing too many serious side effects. The fourth group (15 people) moved into a Phase II stage at the doses identified from Phase I. All participants also received a second treatment combination called Carboplatin and Etoposide as part of the overall treatment plan. The reported data shows that in the Phase I stage, across the three dose groups, the number of participants who experienced what the researchers defined as a "dose limiting toxicity" (a serious side effect serious enough to set the upper limit for dosing) was 0 in the lowest-dose group, 1 in the middle-dose group, and 1 in the highest-dose group. In the Phase II stage, 8 out of 15 participants were reported as experiencing adverse events (unwanted health effects). For the secondary outcome, the reported data shows a progression-free survival figure of 6.0 months — this means the reported median time before the disease was measured as getting worse was 6 months. It is worth noting that some figures in the submitted data were not broken down in further detail beyond what is described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01387282 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01387282) enrolled 495 people in total — 330 received a drug called anamorelin HCl and 165 received a placebo (a dummy treatment with no active ingredient). The trial was looking at people experiencing muscle wasting and poor appetite related to cancer (a condition sometimes called cachexia/anorexia). Over 12 weeks, the trial measured two main things: changes in lean body mass (the amount of muscle and other non-fat tissue in the body) and changes in handgrip strength (how hard a person can squeeze with their non-dominant hand). Several secondary measures were also tracked, including body weight, appetite-related quality of life scores, and fatigue scores. The reported data shows that, on average, people in the anamorelin group had a lean body mass change of +0.65 kg (a small increase), while those in the placebo group had a change of −0.98 kg (a small decrease). For handgrip strength, the reported data shows both groups experienced a decline on average — the anamorelin group by −1.49 kg of force and the placebo group by −0.95 kg of force. For body weight, the anamorelin group showed an average increase of +0.95 kg, while the placebo group showed an average decrease of −0.57 kg. On the appetite and cachexia symptom questionnaire (scored 0–48, where higher is better), the anamorelin group's score changed by +3.48 points on average, compared with +1.34 points in the placebo group. The fatigue questionnaire (scored 0–52, where higher is better) showed very similar changes in both groups: +1.37 points for anamorelin and +1.23 points for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01466660 · results posted 19 June 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01466660) enrolled 319 people with lung cancer — 160 in the afatinib group and 159 in the gefitinib group. The trial was measuring how long participants went without their disease getting worse (called progression-free survival), how long they stayed on their treatment (time to treatment failure), and how long they lived overall (overall survival). It also looked at how many participants' tumours shrank or disappeared, and for how long. The reported data shows that, for the main measure of how long disease stayed stable, the afatinib group had a median of about 12.8 months compared with about 11.2 months in the gefitinib group. (A "median" simply means the middle value — half of participants had a longer time and half had a shorter time.) For how long participants stayed on treatment, the reported medians were about 13.7 months for afatinib and about 11.5 months for gefitinib. For overall survival, the reported median figures were about 27.9 months in the afatinib group and about 24.5 months in the gefitinib group. Regarding tumour response, the reported data shows that approximately 79% of participants in the afatinib group and approximately 75% in the gefitinib group had their tumour shrink or disappear, with that response lasting a median of about 11.9 months and 11.1 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01802632 · results posted 6 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01802632) tested a medicine called AZD9291 (also known as osimertinib) in people with a type of lung cancer. A total of 603 participants were enrolled across six sub-groups: an 80mg extension group (201 people), a dose escalation group (31 people), a dose expansion group (271 people), a first-line group (60 people), an 80mg tablet group (12 people), and a Japan cytology group (28 people). The trial was primarily measuring how many participants' tumours shrank or disappeared — a measure called "objective response rate" (ORR) — as well as tracking how long any shrinkage lasted and how long participants went without their cancer growing. The reported data shows the following for the main groups. In the dose expansion group (271 participants), 61.7% of participants had their tumours shrink or disappear in a confirmed way. In the dose escalation group (31 participants), the best responses recorded were: tumours shrank or disappeared in 58.1% of participants, disease stayed stable (neither growing nor shrinking enough to count as a response) in 19.4%, disease progressed in 16.1%, and results were not evaluable for 6.5%. For the 80mg extension group (201 participants), 61.6% had confirmed tumour shrinkage or disappearance, while the breakdown of best individual responses was: complete disappearance of tumours in 1.0%, partial shrinkage in 70.1%, stable disease in 21.9%, progression in 6.5%, and not evaluable in 0.5%. The reported data also shows two secondary (additional) measurements for the dose expansion group. The median duration of response — meaning the midpoint of how long tumour shrinkage lasted among those who responded — was reported as 11.1 months. The median progression-free survival — the midpoint of how long participants went before their cancer grew or they died — was reported as 9.7 months. No corresponding duration figures for the other sub-groups were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00949910 · results posted 4 October 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 6,586 people, all of whom received the drug erlotinib. Only 10 participants were recorded as completing the study, while the remaining 6,576 did not complete it — though the data does not explain the reasons for non-completion in detail. The trial was primarily measuring how many participants showed an "objective response" to erlotinib — meaning their cancer either disappeared completely or shrank by at least 30% according to standardised tumour-measurement rules called RECIST. The reported data shows that approximately 11% of participants met the definition for an objective response. When looking at the broader category of "disease control" — which also includes people whose cancer stayed stable and did not grow significantly — the reported figure was around 56%. Breaking this down further, roughly 0.7% of participants had a complete disappearance of detectable cancer, about 10% had a meaningful shrinkage (partial response), and about 45% had stable disease. Around 23% experienced disease progression (meaning their cancer grew), and 18% were not able to be evaluated. The reported data also shows that approximately 93% of participants either died or experienced disease progression during the study, and 81% died from any cause. The median time before disease progression or death — known as "progression-free survival" — was reported as 3.3 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01233687 · results posted 1 September 2016
According to the results reported on ClinicalTrials.gov, this trial tested a combination of two drugs — AMG 102 and erlotinib — in people with advanced non-small cell lung cancer (a type of lung cancer) who had already received prior treatment. The trial ran in two stages: a first stage involving 7 participants to work out the right dose to use, and a second stage involving 49 participants (of whom 45 were able to be assessed for their response to treatment). In total, 56 people took part across both stages. The reported data shows that in the first stage, none of the 7 participants experienced what the trial defined as a "dose-limiting toxicity" — meaning a side effect serious enough to prevent them receiving the planned dose — giving a reported rate of 0%. For the main measure in the second stage, the trial tracked what is called the "Disease Control Rate" — the proportion of participants whose cancer either shrank, partially shrank, or stayed stable rather than growing. The reported figure for this was 60% of assessed participants. On a narrower measure called the "Objective Response Rate" — which counted only those whose cancer partially shrank — the reported figure was 8.8%. The reported data also shows that the middle-point figure (known as the median, meaning half of participants fell above this and half below) for how long participants lived without their disease getting worse was 2.6 months, and the median length of time participants remained alive overall was 6.6 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01450761 · results posted 18 July 2016
According to the results reported on ClinicalTrials.gov, this trial involved 1,132 people in total — 566 in each group. Participants were randomly assigned to receive either ipilimumab (a type of immunotherapy) combined with standard chemotherapy (platinum and etoposide), or a placebo (an inactive dummy treatment) combined with the same chemotherapy. The trial was primarily measuring how long participants lived overall, and also looked at how long it was before their disease got worse or they passed away. The reported data shows that, among those who received at least one dose of the blinded study treatment, the median overall survival — that is, the midpoint time at which half of participants in each group had passed away — was approximately 10.97 months in the ipilimumab-plus-chemotherapy group and 10.94 months in the placebo-plus-chemotherapy group. When looking at all participants who were originally enrolled (not just those who received the blinded treatment), the reported median overall survival was 10.22 months in the ipilimumab group and 9.95 months in the placebo group. For the secondary measure of how long it was before the disease progressed or death occurred, the reported median was 4.63 months in the ipilimumab group and 4.44 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00982111 · results posted 27 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 315 people in the necitumumab plus pemetrexed plus cisplatin group, and 318 people in the pemetrexed plus cisplatin (chemotherapy only) group. The trial was looking at whether adding a medicine called necitumumab to a standard two-drug chemotherapy combination made a difference for people with a type of lung cancer called non-squamous non-small cell lung cancer. The main thing being measured was how long participants lived overall, and several other things were also tracked, including how long before the cancer started growing again, how many participants' tumours shrank, and how long participants stayed on treatment. The reported data shows that for overall survival — the time from entering the trial until death from any cause — the median (the midpoint value across all participants) was 11.3 months in the necitumumab plus chemotherapy group and 11.5 months in the chemotherapy-only group. For progression-free survival — the time until the cancer was seen to be growing or until death — both groups had a reported median of 5.6 months. When looking at tumour shrinkage, about 31.1% of participants in the necitumumab group and 32.1% in the chemotherapy-only group had their tumours shrink meaningfully. The time to treatment failure — how long before treatment stopped working or was stopped — was reported as 3.5 months in the necitumumab group and 4.3 months in the chemotherapy-only group. The reported data also shows that 37 participants in the necitumumab group were assessed for antibodies to the drug, of whom 18 were found to have developed them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01285609 · results posted 23 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 956 people in total — 479 were randomly assigned to receive ipilimumab alongside the chemotherapy drugs paclitaxel and carboplatin, while 477 received a placebo alongside the same chemotherapy. The trial was measuring how long participants lived overall (called "overall survival"), and how long they lived without their cancer getting worse (called "progression-free survival," meaning the time before the disease progressed or death occurred). The reported data shows that, among participants who received at least one dose of the blinded (unknown to them) study treatment, the median overall survival — that is, the midpoint in survival time across the group — was 13.37 months for those in the ipilimumab group and 12.42 months for those in the placebo group. When looking at all randomised participants together, the reported median overall survival figures were 10.94 months for the ipilimumab group and 10.74 months for the placebo group. For progression-free survival, the reported median was 5.55 months in the ipilimumab group and 5.59 months in the placebo group, among those who received at least one dose of blinded therapy. No other outcome figures were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00932451 · results posted 9 June 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT00932451) enrolled 1,066 people who all received crizotinib 250 mg twice daily. The trial was measuring how a tumour responded over time, including how long any response lasted, how quickly it appeared, and how long participants lived. Of the 1,066 people who started, 244 completed the study and 822 did not complete it (the reasons for not completing were not detailed in the data provided here). The reported data shows a range of measurements across the group. For how long a tumour response lasted (called "duration of response"), the figures reported were 11.8 months and 9.5 months — these likely represent different summary points for the same group, though the data does not clarify further. The time it took for a response to first appear was reported as approximately 6.1 to 6.3 weeks. When looking at whether the disease was controlled (meaning the tumour had shrunk or stopped growing) at 6 weeks and 12 weeks, the reported figures ranged from about 61% to 82% of participants, depending on the time point and the population measured. The reported data shows that the time before the disease worsened or a participant died (progression-free survival) was 8.4 months and 6.9 months. For overall survival — the time from starting treatment until death from any cause — the figures reported were 21.8 months and 16.9 months. The estimated probability of being alive at 6 months was reported as between 77.5% and 81.7%, and at 1 year as between 62.4% and 66.5%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00451906 · results posted 25 April 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,252 people, all of whom received a combination of bevacizumab and chemotherapy. Only 13 participants were recorded as having completed the study, while 2,239 did not complete it. The trial was primarily focused on tracking specific unwanted events (called adverse events) that had been identified as being of particular interest with this treatment, as well as serious unwanted events considered to be related to bevacizumab. It also measured how long participants lived overall and how long it was before their disease got worse. The reported data shows that, out of 2,252 participants, the numbers who experienced each of the specific adverse events of interest were: high blood pressure – 687; protein in the urine – 672; wound healing problems – 26; a hole or tear in the gut – 30; blood clot or arterial blockage events – 274; coughing up blood – 176; bleeding in the brain or spinal cord – 7; other bleeding events – 744; and heart failure – 17. A total of 283 participants experienced a serious adverse event considered to be related to bevacizumab. For the secondary measures, the reported data shows that the middle value (median) for overall survival — meaning the point at which half the participants had died and half were still alive — was 14.6 months. The median time before disease progression was recorded as 7.8 months. Regarding bleeding in the brain or nervous system among a specific subgroup, 12 and 16 participants were reported across two separate measurements (the data does not specify exactly how these two figures were divided). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00828139 · results posted 4 April 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 189 people with a form of ovarian cancer. Participants were divided into four groups based on how their cancer had previously responded to platinum-based chemotherapy: those whose cancer had responded (called "platinum-sensitive") and those whose cancer had not responded (called "platinum-refractory"). Within each of those two categories, people were randomly assigned to receive either the chemotherapy drug topotecan on its own, or topotecan combined with a second drug called ziv-aflibercept. The trial's main goal was to measure "progression-free survival" — that is, how long participants went before their cancer got worse or they experienced significant deterioration in their health. The reported data shows that progression-free survival — the main outcome being measured — was short across all four groups. In the platinum-sensitive groups, the reported figures were 1.8 months for those receiving the combination treatment and 1.3 months for those receiving topotecan alone. In the platinum-refractory groups, both the combination and the topotecan-alone groups reported 1.4 months. For overall survival (how long participants lived in total), the reported figures were 6.0 months, 4.6 months, 4.6 months, and 4.2 months for the four groups respectively. The reported data also shows that very few participants had their tumours shrink: roughly 2 in 100 participants in each combination-treatment group showed a measurable tumour response, while no measurable responses were recorded in either topotecan-alone group. A small number of participants across both treatment groups experienced serious side effects (graded 3 to 5) considered related to the study drugs, though the full breakdown of those events was not clearly separated in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01642004 · results posted 17 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 272 people with a type of lung cancer who were randomly assigned to receive either nivolumab (135 people) or docetaxel (137 people) — both are medicines given when the cancer has continued to grow after earlier treatment. The trial's main focus was on how long participants lived after joining the trial (called "overall survival"), and it also looked at whether tumours shrank and for how long. The reported data shows that the median overall survival — meaning the point in time by which half of participants in each group had died — was 9.23 months for the nivolumab group and 6.01 months for the docetaxel group. Looking at survival rates at set time points, the reported probability of still being alive at 6 months was about 64% for nivolumab and 51% for docetaxel; at 12 months, about 42% versus 24%; and at 18 months, about 28% versus 13%. In total, 86 deaths were recorded in the nivolumab group and 113 in the docetaxel group during the period measured. On the secondary measures, 20% of participants in the nivolumab group had their tumour shrink to a meaningful degree compared with 8.8% in the docetaxel group. Among those whose tumours did shrink, the response lasted a reported median of about 24.5 months for nivolumab and 8.4 months for docetaxel, with the time it took for a response to first appear being similar in both groups (around 2 months). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00257608 · results posted 15 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,145 people in an initial chemotherapy phase, where all participants received bevacizumab alongside one of several chemotherapy combinations. Of those, 769 completed that phase. Participants who responded well enough then moved into a second phase, where 373 people were assigned to bevacizumab plus a placebo and 370 were assigned to bevacizumab plus a drug called erlotinib. The trial's main goal was to measure how long people went without their disease getting worse (called "progression-free survival"). The reported data shows that, for the primary measure of progression-free survival, people in the bevacizumab-plus-placebo group went a median (meaning the midpoint figure — half went longer, half went shorter) of 3.7 months without their disease progressing, while people in the bevacizumab-plus-erlotinib group had a median of 4.8 months. Regarding the secondary measures, the reported data shows that during the post-chemotherapy phase, 319 out of 373 participants in the placebo group and 353 out of 370 in the erlotinib group experienced at least one adverse event (an unwanted medical occurrence). Numbers of participants who stopped treatment for reasons other than their disease getting worse, and counts of specific serious adverse events such as bleeding in the lungs, bowel perforations, and high blood pressure, were also recorded across both phases, with figures varying by group and event type as detailed in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01673867 · results posted 26 February 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01673867) enrolled 582 people with lung cancer — 292 assigned to receive nivolumab and 290 assigned to receive docetaxel (a chemotherapy medicine). The trial was designed to compare these two treatments in people whose cancer had continued to grow after earlier treatment. The main thing researchers measured was overall survival — that is, how long participants lived after joining the trial. Several secondary measures were also tracked, including how many people's tumours shrank, how quickly that happened, how long any shrinkage lasted, how long it took before the cancer worsened, and whether participants reported an improvement in their symptoms by week 12. The reported data shows that the middle (median) survival time — meaning the point at which half of participants in each group had died and half had not — was 12.19 months in the nivolumab group and 9.36 months in the docetaxel group. For the secondary measures, the reported data shows that 19.5% of nivolumab participants and 12.8% of docetaxel participants had their tumours shrink to a meaningful degree. Among those whose tumours did shrink, the median time before the tumour started growing again was reported as 17.15 months for nivolumab and 5.55 months for docetaxel. The median time until the cancer first showed signs of worsening (for all participants, not just those who responded) was 2.33 months for nivolumab and 4.44 months for docetaxel. Tumour shrinkage was first recorded at a median of 2.10 months for nivolumab and 2.73 months for docetaxel. Regarding symptom improvement by week 12, 17.8% of the nivolumab group and 19.7% of the docetaxel group reported a meaningful reduction in their symptom burden score on a standard lung cancer questionnaire. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00367601 · results posted 11 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people, and all 25 completed the study. Participants had an advanced form of lung cancer (non-small cell lung cancer) and were considered by their doctors to be in a relatively poor general state of health (referred to as "performance status 2," meaning day-to-day activities were noticeably affected by their illness). The trial used a single treatment group — there was no comparison group — and it set out to measure how many participants had disease that had not grown or spread after four months, as well as how long it took for the disease to progress and how long participants survived overall. The reported data shows that 28% of participants — roughly 1 in 4 — had disease that had not progressed at the four-month mark. For the secondary measures, the reported data shows that the middle value (median) for time until the disease got worse was 3.4 months, and the middle value for overall survival was 5.1 months. A median figure simply means that half of the participants in the group reached that point sooner, and half took longer. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00590902 · results posted 20 January 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 81 participants, all of whom received a treatment called OSI-774 (also known as erlotinib). Eighty of the 81 participants completed the study, with one person not completing it. The trial was measuring how tumours responded to the treatment, using a standard set of rules called RECIST criteria, which looks at whether tumours disappeared, shrank, stayed the same, or grew. The reported data shows four categories of tumour response among the participants. One participant had a complete response, meaning all measurable tumour lesions disappeared. Eighteen participants had a partial response, meaning their tumours shrank by at least 30%. Thirty-one participants had stable disease, meaning their tumours neither shrank enough to count as a partial response nor grew enough to count as progression. Thirty participants had progressive disease, meaning their tumours continued to grow. Results for any secondary outcome measures were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00686959 · results posted 26 November 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 301 people in one group and 297 in another — a total of 598 participants. The trial compared two different chemotherapy combinations, both given alongside radiation therapy, in people with a type of lung cancer. One group received pemetrexed plus cisplatin with radiation (Arm A), and the other received etoposide plus cisplatin with radiation (Arm B). The trial was primarily measuring how long participants lived overall, and also tracked how long they lived without their disease getting worse, how many showed a measurable reduction in tumour size, and their chances of surviving at one, two, and three years. The reported data shows that the median overall survival — that is, the point in time by which half the participants had died — was approximately 26.8 months in Arm A and approximately 25.0 months in Arm B. For progression-free survival (how long participants lived without their disease getting worse), the reported figures were approximately 11.4 months in Arm A and approximately 9.8 months in Arm B. When it came to tumour response, about 35.9% of participants in Arm A and 33.0% in Arm B showed a measurable reduction in tumour size. The reported survival probabilities at one, two, and three years were very similar between the two groups: roughly 76–77% of participants in both groups were estimated to be alive at one year, around 52% at two years, and approximately 40% (Arm A) and 37% (Arm B) at three years. The reported data also shows information about deaths that occurred while participants were on the study drug or within 30 days of stopping treatment, though the breakdown across the multiple reported categories was not straightforward to summarise from the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01193868 · results posted 18 November 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom completed the study with none dropping out. The trial tested a single treatment called RO4929097 and was primarily measuring how tumours responded to it, using a standard set of criteria called RECIST (Response Evaluation Criteria in Solid Tumours). In simple terms, RECIST is a set of rules that doctors use to measure whether tumours shrink, stay the same, or grow during treatment. The trial also aimed to look at certain biological markers in tumour tissue — such as "Notch pathway" proteins and stem cell markers — and how these related to the way tumours behaved. The reported data shows that, of the 6 participants, none had a complete response (meaning no one's tumours disappeared entirely) and none had a partial response (meaning no one had tumours shrink by at least 30%). The reported figures show that 100% of participants were recorded as having "stable disease," meaning their tumours neither shrank enough to count as a response nor grew enough to count as progression. No participants were recorded as having progressive disease (tumour growth). For the second primary outcome — measuring the percentage change in tumour size as a continuous number — no data was reported. Similarly, for all of the secondary outcome measures relating to tumour biological markers, no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01204697 · results posted 16 November 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01204697) enrolled 74 people in total — 36 in a group receiving a medicine called erlotinib on its own, and 38 in a group receiving erlotinib combined with another medicine called docetaxel. The trial was primarily looking at the proportion of participants who were free from their cancer getting worse (or who had not died) at the six-month mark. It also tracked a number of secondary measures, including how long it was before the disease progressed, how long participants survived overall, how many showed a measurable reduction in their cancer, and how many had their disease kept under some level of control. The reported data shows that for the primary measure — the percentage of participants free from disease progression or death at six months — the figure was 8.3% in the erlotinib-only group and 8.1% in the combination group. For the secondary measures: the median time before disease progressed was reported as approximately 2.33 months in the erlotinib-only group and 2.82 months in the combination group. Median overall survival was reported as 5.61 months and 8.95 months respectively. The percentage of participants whose cancer showed a measurable shrinkage (either a complete or partial response) was 2.8% in the erlotinib-only group and 8.1% in the combination group. Disease control (meaning the cancer either shrank or stayed stable) was reported in 41.7% and 37.8% of participants respectively. For how long responses lasted, the data was not reported for the erlotinib-only group; in the combination group it was reported as approximately 8.69 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00993499 · results posted 7 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00993499) enrolled 44 participants in total across six groups. Each group received a different combination of two medicines — afatinib and sirolimus — at varying doses. The trial was primarily looking at what are called "dose-limiting toxicities," meaning unwanted side effects serious enough to put a limit on how much of the medicines could be given. Participants went through a short run-in period and then continued into further treatment courses, though not everyone completed all stages. The reported data shows that across the six dose groups, the number of participants who experienced a dose-limiting toxicity ranged from 2 to 4 people per group. For tumour response, the trial used a standard measurement system to categorise how each participant's cancer appeared to change. The reported data shows that in most groups, 0% of participants had an objective response (meaning a measurable shrinkage of the tumour), with the exception of one group (afatinib 30mg + sirolimus 0.5mg) where approximately 8% did, another group (afatinib 30mg + sirolimus 0.5mg — noting the data as labelled) where 22% did, and one smaller group (afatinib 40mg + sirolimus 5mg, which had only 3 participants) where 66.7% did. When a broader measure called "disease control" was used — which includes tumour shrinkage or the cancer staying stable — the reported percentages ranged from 33.3% to 100% across the groups. Blood-level measurements of afatinib were reported for some groups but not all, and the genetic mutation analysis outcome was not analysed because, as noted in the submitted data, available data was too limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00769067 · results posted 21 August 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00769067) enrolled 94 participants in each of two groups — one group received a medicine called erlotinib and the other received a medicine called dacomitinib — giving 188 people in total. The trial was measuring quality of life (how participants felt day-to-day), skin-related wellbeing, and some biological markers in blood and tumour tissue in people with lung cancer. Notably, the reported data shows that zero participants in either group were recorded as having "completed" the study, meaning all participants left the study before it formally concluded, for reasons not detailed in this data. The reported data shows that for general quality of life (using a standard questionnaire called the EORTC QLQ-C30), roughly similar numbers of participants in each group were categorised as improved, stable, or worsened over the course of the trial. For a lung cancer–specific quality of life questionnaire (EORTC QLQ-LC13), the numbers were again broadly comparable between groups, though slightly more dacomitinib participants were categorised as improved on lung-specific symptoms (24 versus 18) and slightly more were also categorised as worsened (37 versus 24). A separate skin quality of life score (called the DLQI, where higher numbers mean greater impact on daily life from skin problems) started very low in both groups and rose over time; by later time points the dacomitinib group reported scores around 5.4–5.9 compared with around 3.6–4.1 in the erlotinib group. Blood protein levels and genetic marker data (such as EGFR and KRAS mutation status) were also collected and reported numerically, though the clinical meaning of those figures was not explained in this data submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00940875 · results posted 2 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people in total — 31 in a group receiving the chemotherapy drug gemcitabine on its own, and 23 in a group receiving gemcitabine combined with a second drug called erlotinib. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as how many participants responded to treatment, how many were still stable at certain time points, and how long participants lived overall. The reported data shows that when it came to disease getting worse or death — the main thing the trial was tracking — roughly 96% of participants in both groups experienced one of those events during the study period. The middle point (median) for how long participants went without their disease progressing was reported as 8.0 weeks for the gemcitabine-only group and 10.3 weeks for the combination group. For overall survival, the reported median time was 21.3 weeks in the gemcitabine-only group and 17.1 weeks in the combination group. Regarding tumour response, 7.1% of the gemcitabine-only group and 3.8% of the combination group were reported to have had a measurable reduction in tumour size. The reported data shows that at the 8-week mark, 50% of the gemcitabine-only group and 38.5% of the combination group had not progressed; by 16 weeks those figures were 25% and 11.5% respectively. The percentage of participants who died during the study was reported as 92.9% in the gemcitabine-only group and 76.9% in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00066365 · results posted 30 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in total — 31 in a group whose cancer had returned on one side (unilateral recurrence) and 18 in a group whose cancer had returned on both sides (bilateral recurrence). All participants received a drug called sargramostim along with surgery to remove the affected lung tissue (thoracotomy). The trial was measuring specific proteins found in tumour tissue samples — called FAS, FAS Ligand, and CD1a — both before and after chemotherapy. These proteins are thought to be involved in how the immune system responds to cancer cells. Only 8 participants in the first group and 4 in the second group completed the study; the remaining 37 did not complete it, though the reasons were not detailed in the reported data. The reported data shows the number of participants in whose tissue samples these proteins were detected, measured using a laboratory staining method. For FAS Ligand before chemotherapy, results were only reported for the bilateral group (Group 2), with measurements of 7, 5, 1, and 1 participants across different measurement categories. For FAS before chemotherapy, again only Group 2 data was reported, with 5, 5, 2, and 2 participants across categories. After chemotherapy, both groups had data reported: for FAS Ligand, the counts were 16, 4, 1, and 1 participants in Group 1, and 7, 2, 2, and 2 in Group 2. For FAS after chemotherapy, Group 1 showed counts of 14, 4, 1, and 3 participants, while Group 2 showed 5, 4, 0, and 4. For the CD1a protein before chemotherapy, only Group 2 data was reported, with 5 and 2 participants in each category. After chemotherapy, CD1a results for Group 1 showed 8 participants in one category and 12 in another, while Group 2 showed 5 and 2. It is worth noting that the reported data does not clearly label what each measurement category represents for these protein levels, so a precise plain-English description of each individual number is not possible from the information provided. The data also appears incomplete for some measures, with pre-chemotherapy results only reported for one of the two groups rather than both. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01121575 · results posted 30 March 2015
According to the results reported on ClinicalTrials.gov, this trial tested two medicines — crizotinib and dacomitinib — given together at different dose combinations in people with cancer. A total of 70 participants took part across six groups: four groups tested different dose combinations in an early "escalation phase" (designed to find the right dose), and two further "expansion cohorts" tested the combination in a larger group once a dose had been identified. The trial was primarily measuring unwanted medical events (called adverse events) that occurred during treatment, as well as identifying whether any doses caused particularly serious reactions known as "dose-limiting toxicities" — meaning side effects serious enough to limit how much of the drug could be given. The reported data shows that in the escalation phase, all 33 participants across the four dose groups experienced at least one adverse event of any kind. Among those, between 3 and 9 participants in each group experienced more severe reactions (graded as serious or worse). In terms of adverse events considered directly related to the study treatment, between 3 and 8 participants per group in the escalation phase experienced these more severe, treatment-linked reactions. Dose-limiting toxicities were reported in only one participant — in the group receiving crizotinib 200 mg twice daily plus dacomitinib 45 mg once daily. In the expansion phase (37 participants across two cohorts), the reported data shows 22 and 11 participants respectively experienced adverse events of any kind, with 12 and 8 experiencing more severe reactions, and 3 and 2 deaths recorded across the two cohorts. As a secondary measure, the trial also recorded how many participants had "stable disease" — meaning their cancer neither shrank nor grew significantly for at least six weeks. The reported data shows this ranged from 2 to 10 participants across the four escalation dose groups, though the full breakdown of how long that stability lasted was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00124618 · results posted 17 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 58 participants, all of whom received a combination of cetuximab (a type of targeted medicine) and radiation therapy. Fifty-seven of the 58 participants completed the study. The trial was set up to measure whether patients were still alive at 11 months — a timepoint chosen because it was considered an improvement on what is typically seen with radiation treatment alone. It also tracked how long participants survived overall, how long it took for the disease to get worse, and whether tumours shrank. The reported data shows that 70% of participants were alive at the 11-month mark. The reported median survival time — meaning the point at which half the participants had passed away and half were still alive — was 15.1 months. The median time to disease progression — that is, the point at which the disease was recorded as getting worse — was 7.2 months. Regarding tumour response, the reported data shows that 15 participants had a confirmed tumour response (either the tumour shrinking significantly or disappearing), while no participants had a partial response recorded separately under the study's reporting categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00556322 · results posted 23 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 424 people in total — 221 in the comparator group and 203 in the erlotinib group. The trial was measuring overall survival, meaning how long participants lived from the time they were randomly assigned to a treatment group. Results were recorded up to a data cut-off date of 7 September 2010. The trial also looked at survival separately in people whose tumours tested positive or negative for a particular gene marker called EGFR (a protein found on the surface of some tumour cells). The reported data shows that, across all participants, around 81% of those in the comparator group and around 78% of those in the erlotinib group had died by the data cut-off date. The estimated midpoint survival time — the point at which roughly half of participants in each group had died — was reported as 5.5 months for the comparator group and 5.3 months for the erlotinib group. The estimated proportion of participants still alive at one year was reported as 24% in the comparator group and 26% in the erlotinib group. When looking separately at participants whose tumours tested positive for the EGFR marker, the estimated midpoint survival was 5.5 months (comparator) versus 5.6 months (erlotinib), and for those who tested negative it was 6.7 months (comparator) versus 5.4 months (erlotinib). The reported data shows that the one-year survival estimate in the EGFR-positive group was 27% (comparator) and 30% (erlotinib), while in the EGFR-negative group it was 28% (comparator) and 20% (erlotinib). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01183858 · results posted 23 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 313 people in total — 154 in a group receiving a standard 150 mg daily dose of erlotinib and 159 in a group receiving a higher 300 mg daily dose. The trial was comparing these two doses to see how long participants went without their disease getting worse (called "progression-free survival"), as well as how long they survived overall, how their tumours responded to treatment, and what unwanted effects they experienced. Very few participants — just 1 in the lower-dose group and 3 in the higher-dose group — completed the study, with the remainder not completing it for various reasons. The reported data shows that for the main measure — the time from starting treatment until the disease progressed or the participant died — the lower-dose group had a reported median (the midpoint value across all participants) of about 6.9 weeks, and the higher-dose group about 7.0 weeks. For overall survival (time from starting treatment until death from any cause), both groups had a reported median of around 6.8 months. When looking at tumour response, 0% of participants in either group showed a complete response (tumour disappearing entirely), while about 7% in the lower-dose group and 2.5% in the higher-dose group showed a partial response (tumour shrinking meaningfully). Around 40% of the lower-dose group and 37% of the higher-dose group had their disease reported as "controlled" (meaning it either shrank or stayed stable for a period of time). Regarding unwanted effects, the reported data shows that 130 of 154 participants in the lower-dose group and 141 of 158 in the higher-dose group experienced at least one adverse event (an unwanted or unintended health event during the study). Serious adverse events were reported in 29 participants in the lower-dose group and 35 in the higher-dose group. Events leading to withdrawal from treatment occurred in 18 and 15 participants respectively, and events that led to death were reported in 12 and 13 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00556712 · results posted 11 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 889 people in total — 451 received a placebo (an inactive treatment) and 438 received erlotinib at 150 milligrams per day. The trial was looking at people with cancer and was primarily measuring "progression-free survival" — that is, how long participants went without their disease getting worse or without dying. It also tracked how many participants were still alive and free of worsening disease at six months, and later recorded overall survival (how long participants lived in total). The reported data shows that, at the first data check (May 2008), the middle point ("median") time before disease worsening or death was 11.1 weeks in the placebo group and 12.3 weeks in the erlotinib group. At six months, approximately 15% of placebo participants and 25% of erlotinib participants were reported as still alive with no disease progression. The reported data also shows that around 89.5% of placebo participants and 79.9% of erlotinib participants had experienced disease worsening or death by that cutoff point. At a later data check (January 2012), the reported median overall survival — the middle point for how long participants lived — was 11.0 months in the placebo group and 12.4 months in the erlotinib group. By that time, 87.1% of placebo participants and 82.0% of erlotinib participants were reported to have died. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01190527 · results posted 14 January 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01190527) enrolled 42 participants, all of whom completed the study. The trial was looking at a type of radiation treatment called "adaptive radiation," which used specialised PET-CT scans (a type of imaging that shows how active tumour cells are) taken during the course of radiation therapy. The idea being tested was whether using these scans to guide a higher radiation dose to the most active parts of the tumour would affect local-regional tumour control (whether the tumour in and around the treated area was kept in check) and survival over two years. The reported data shows that, for the primary measure — the rate of local-regional tumour control at two years — 68% of participants had their tumour controlled in the treated area at that point. On the secondary measures, all 42 participants were reported to have been able to receive the higher, escalated radiation dose. The reported data also shows that 51% of participants were alive at the two-year mark. Regarding side effects that were tracked, the reported figures show that 8 participants experienced radiation-related lung toxicity, and 13 participants experienced inflammation of the oesophagus (the swallowing tube) rated as moderate or severe. It is worth noting that this was a single-group study with no comparison group, so all figures reflect only the one group of 42 people who received the adaptive radiation approach. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01168973 · results posted 29 December 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01168973) enrolled 1,253 people with lung cancer — 628 in the group receiving ramucirumab combined with docetaxel (a chemotherapy medicine), and 625 in the group receiving a placebo (an inactive substance) combined with docetaxel. The trial was primarily measuring overall survival — that is, how long participants lived from the time they joined the study. It also measured a number of secondary outcomes, including how long it took for the cancer to grow or spread (called progression-free survival), how many participants' tumours shrank or disappeared, how many achieved disease control, and how participants rated their symptoms and quality of life using standardised questionnaires. The reported data shows that, on average, participants in the ramucirumab-plus-docetaxel group lived for 10.5 months from the start of the study, compared with 9.1 months in the placebo-plus-docetaxel group. For progression-free survival, the reported figures were 4.5 months in the ramucirumab group and 3.0 months in the placebo group. The reported data also shows that 22.9% of participants in the ramucirumab group had their tumours shrink or disappear (called an objective response), compared with 13.6% in the placebo group. Disease control — meaning tumours that shrank, disappeared, or stayed stable — was reported in 64.0% of the ramucirumab group and 52.6% of the placebo group. For the symptom and quality-of-life questionnaires, the reported data shows that both groups recorded similar scores. On the lung cancer symptom scale, the largest improvements seen over the course of the study were in a similar range for both groups (for example, around –10.9 mm versus –11.0 mm on one measure, with the full scale running to 100 mm, where a decrease means fewer symptoms reported). On the quality-of-life questionnaire completed at a follow-up visit 30 days after treatment, both groups reported a small decrease in their scores from where they started, with figures of –0.140 versus –0.126 on the health state index, and –5.9 versus –6.1 on the visual rating scale (where higher scores mean better health). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01813721 · results posted 24 December 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,007 patients receiving chemotherapy, with 943 completing the study and 64 not completing it. Rather than testing a drug or procedure, the trial was an observational study that asked doctors to record which factors they considered most important when judging a patient's risk of developing febrile neutropenia — a serious condition where chemotherapy lowers the body's infection-fighting white blood cells, causing fever. The study also looked at what factors doctors weighed up when deciding whether to prescribe a preventive medicine called G-CSF (a drug that stimulates white blood cell production). The reported data shows that, when doctors were asked to rank risk factors for febrile neutropenia, 88.3% of investigators listed the type of chemotherapy regimen as important, and 73.4% listed the patient's age as important. When the same question was looked at from the patient side — that is, for how many individual patients did doctors flag these factors — the type of chemotherapy was ranked as important for 92.6% of patients, while age was flagged for 39.4% of patients. Other factors that large proportions of investigators considered important included the patient's general health status (83.0%), prior history of febrile neutropenia (76.2%), and planned chemotherapy dose intensity (70.5%), among others listed in the data. The reported data also shows that, when doctors were deciding whether to prescribe preventive G-CSF treatment, the top factors they ranked as important included the chemotherapy regimen (88.7% of investigators), the patient's overall health status (79.7%), and the patient's age (73.8%). These findings reflect what doctors reported they were thinking about — not the outcomes patients experienced. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01523587 · results posted 21 November 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01523587) enrolled 398 people in the afatinib group and 397 people in the erlotinib group — a total of 795 participants. Both afatinib and erlotinib are tablet medicines used in lung cancer treatment. The trial was comparing how long people in each group went without their cancer growing or spreading (called "progression-free survival"), as well as several other measures such as overall survival, tumour shrinkage, and changes in symptoms like cough, breathlessness, and pain. The reported data shows that, on average, people in the afatinib group went approximately 2.63 months before their cancer progressed or they passed away, compared to approximately 1.94 months in the erlotinib group — both figures based on independent medical image reviews. For overall survival (time from the start of the trial until death), the reported average was approximately 7.82 months for the afatinib group and 6.77 months for the erlotinib group. When looking at tumour response, 22 out of 398 participants in the afatinib group and 11 out of 397 in the erlotinib group showed a measurable shrinkage in their tumours. Disease control (meaning tumours that shrank, stayed the same, or disappeared) was reported in 201 participants in the afatinib group and 157 in the erlotinib group. For tumour size changes overall, the reported data shows an average *increase* in tumour size in both groups (afatinib: +78.8 mm, erlotinib: +80.0 mm). The reported data also shows changes in symptoms over time. For cough, 147 people in the afatinib group and 120 in the erlotinib group showed an improvement. For breathlessness, 174 versus 150 people showed improvement. For pain, two separate measures were recorded: 138 versus 134, and 121 versus 96 participants showing improvement in each group respectively. Note that zero participants were recorded as having formally "completed" the study in either group, which likely reflects the nature of how trial completion was defined rather than meaning no one finished their treatment course — however, the specific reason was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01662635 · results posted 21 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 230 people, with 200 completing the study and 30 not completing it. The trial was looking at three different laboratory testing methods used to detect a genetic change called ALK — a particular alteration in a gene that can be found in some cancer tumours. The three methods tested were FISH (a technique that uses fluorescent tags to spot gene changes), IHC (a staining method that detects certain proteins in tissue), and RT-qPCR (a method that measures genetic material). The goal was to compare how these three tests performed against each other on the same samples. The reported data shows that all 200 completed samples were tested using the FISH method. From those 200 samples, 63 were also tested using IHC, and 48 were tested using RT-qPCR. According to the results reported on ClinicalTrials.gov, the FISH test returned 18 positive results and 182 negative results. The IHC test, run on the smaller group of 63 samples, returned 15 positive results and 48 negative results. The RT-qPCR test, run on 48 samples, returned 5 positive results and 43 negative results. No further breakdown or additional outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00806819 · results posted 20 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 713 people with lung cancer — 353 received nintedanib combined with pemetrexed (a chemotherapy drug), and 360 received a placebo combined with pemetrexed. The trial was primarily measuring "progression-free survival" — that is, how long participants went before their disease got worse or they passed away. It also tracked overall survival (how long participants lived from the start of the trial), tumour response (whether tumours shrank), and how long any shrinkage lasted. Very few participants were recorded as having "completed" the study in the traditional sense (7 in the nintedanib group and 2 in the placebo group), with the large majority not completing it — most likely due to disease progression or death, which is common in trials of this type. The reported data shows that for the primary measure — time until disease progression or death as assessed by an independent review panel — the median (the midpoint figure, where half of participants fared better and half fared worse) was 4.4 months in the nintedanib plus pemetrexed group and 3.6 months in the placebo plus pemetrexed group. For overall survival, the reported median was 12.0 months in the nintedanib group and 12.7 months in the placebo group. A follow-up analysis of progression-free survival gave similar figures: 4.4 months versus 3.4 months by independent review, and 5.3 months versus 4.3 months when assessed by the treating doctors. For tumour response, the reported data shows that approximately 9.1% of the nintedanib group and 8.3% of the placebo group had a confirmed response according to independent review; when assessed by the treating doctors, those figures were 15.0% and 13.3% respectively. The reported data also shows that among those who did have a confirmed tumour response, the median duration of that response was 6.9 months in the nintedanib group and 4.4 months in the placebo group (by independent review), and 6.5 months versus 7.2 months when assessed by the treating doctors. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00531960 · results posted 11 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 124 people in total — 61 in a group receiving bevacizumab combined with chemotherapy, and 63 in a group receiving bevacizumab combined with a targeted medicine called erlotinib. The trial was measuring how long participants went without their cancer getting worse (called progression-free survival), as well as other outcomes such as overall survival, tumour shrinkage, and disease control. The reported data shows that, for the primary outcomes, 72.1% of participants in the bevacizumab-plus-chemotherapy group and 76.2% in the bevacizumab-plus-erlotinib group experienced their disease getting worse or died during the study period. The median time until that point — meaning the point at which half the participants in each group had reached that outcome — was reported as 34.6 weeks for the chemotherapy group and 23.4 weeks for the erlotinib group. For secondary outcomes, 45.9% of participants in the chemotherapy group and 52.4% in the erlotinib group were reported to have died during the study. The median overall survival was not reported (listed as "NA") for the chemotherapy group, and was 16.4 months for the erlotinib group. Tumour shrinkage (a complete or partial response) was recorded in 44.3% of the chemotherapy group and 27.0% of the erlotinib group. Disease control — meaning the cancer shrank or stayed stable for at least four weeks — was reported in 85.2% of the chemotherapy group and 73.0% of the erlotinib group. It is worth noting that the data shows zero participants were recorded as having "completed" the study in either group, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01000025 · results posted 27 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 720 people in total — 480 received an experimental drug called PF-00299804, and 240 received a placebo (a dummy treatment with no active ingredient). The trial was studying people with a type of lung cancer, and its main goal was to measure how long participants lived overall (called "overall survival"). It also looked at a number of secondary goals, including survival in specific patient subgroups, how long it took for the cancer to progress, how many participants showed a measurable response to treatment, and how many experienced side effects. The reported data shows that the median overall survival — meaning the point at which half the participants had passed away and half were still alive — was 6.83 months for those in the PF-00299804 group and 6.31 months for those in the placebo group. For a subgroup of participants whose tumours had a particular genetic feature called "KRAS wild-type," the reported median survival figures were 7.00 months (PF-00299804) and 5.19 months (placebo). For another subgroup with a different genetic feature called an "EGFR mutation," the figures were 7.23 months and 7.52 months respectively. The reported median time before the cancer progressed (got worse) was 2.66 months for PF-00299804 and 1.58 months for placebo. When it came to measurable tumour responses, 7.1% of participants in the PF-00299804 group showed a response, compared with 1.3% in the placebo group. Finally, the reported data shows that 467 out of 480 participants in the PF-00299804 group and 223 out of 240 in the placebo group had recorded side effects, though the data does not provide a breakdown of what those side effects were or how serious they were considered to be. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00362882 · results posted 2 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people in total — 40 in Arm 1 and 41 in Arm 2. All 81 participants completed the study with no drop-outs recorded. The trial was measuring how tumours responded to treatment, how long participants lived overall, how many had their disease controlled or stabilised, and how many were still free from their cancer worsening at the six-month mark. The reported data shows that for the main measure — the proportion of participants whose tumours shrank by a meaningful amount or disappeared entirely — both Arm 1 and Arm 2 had the same result: 10% of participants in each group met that criterion. For overall survival (how long participants lived from the start of the trial), the reported figures were 13.3 months for Arm 1 and 7.8 months for Arm 2. When looking at disease control — meaning tumours that either shrank or stayed stable for at least two treatment cycles — the reported data shows 50% of participants in Arm 1 and 49% in Arm 2 met that measure. Finally, for the proportion of participants whose disease had not worsened at six months, the reported figures were 30% in Arm 1 and 17% in Arm 2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00661778 · results posted 10 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people, all of whom received a combination of three medicines: bevacizumab, cisplatin, and docetaxel. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as other outcomes including how many people's disease responded to treatment, how long any response lasted, and how long participants lived overall. The reported data shows that none of the 50 participants were recorded as having "completed" the study, meaning all 50 left the study before its formal completion — the reasons for this are not detailed in the submitted data. The reported data shows that, on average, participants went approximately 8.95 months before their disease progressed or they passed away. For overall survival — meaning the time from the first dose of treatment until death — the reported average figure was approximately 12.74 months. When looking at one-year survival, the reported data shows that around 53.46% of participants were estimated to still be alive at the one-year mark. In terms of response to treatment, the reported data shows that approximately 67.39% of participants had a measurable reduction in their disease (either a complete disappearance or a significant shrinkage, confirmed on at least two separate check-ups). The duration of how long those responses lasted was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01998919 · results posted 9 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people in total — 79 in the placebo-plus-chemotherapy group and 74 in the erlotinib-plus-chemotherapy group (with slight adjustments after formal randomisation). The trial was measuring whether adding erlotinib (a targeted medicine) to standard chemotherapy made a difference in how people's cancer responded to treatment, compared with adding a placebo (dummy pill) to the same chemotherapy. The main thing the researchers were looking at was how many participants' cancer had not grown or spread by week 8 of treatment. The reported data shows that at week 8, approximately 76.9% of participants in the placebo-plus-chemotherapy group and 80.3% in the erlotinib-plus-chemotherapy group had not experienced disease progression (meaning their cancer had not grown or spread, or had shrunk). For the secondary measures — things the trial also tracked but were not the main focus — the reported data shows that at week 16, non-progression was seen in about 53.8% of the placebo group and 64.5% of the erlotinib group. When looking at participants whose tumours visibly shrank or disappeared, the figures were 24.4% in the placebo group and 36.8% in the erlotinib group. The reported data also shows figures for how long responses lasted and how long it took for the cancer to progress. In the placebo group, the average duration of response was reported as 24.1 weeks, compared with 38.4 weeks in the erlotinib group. The time until the cancer progressed was reported as 24.1 weeks (placebo) versus 31.4 weeks (erlotinib), and progression-free survival — the time until either progression or death — was reported as 23.4 weeks (placebo) versus 30.4 weeks (erlotinib). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00995761 · results posted 3 March 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 participants, all of whom completed the study (none dropped out). The trial was looking at a treatment schedule involving two chemotherapy medicines — docetaxel and cisplatin — given every two weeks to people with a form of lung cancer called unresectable non-small cell lung cancer (meaning the cancer could not be removed by surgery). The trial was designed to measure how many participants' tumours responded to the treatment, as well as how long it took for the disease to progress and how long participants survived overall. The reported data shows that the main result measured was the "response rate" — meaning the proportion of participants whose tumours either disappeared completely or shrank by at least 30% according to scans (CT or MRI). According to the results reported on ClinicalTrials.gov, 64.6% of participants fell into this combined response category. Tumour assessments were carried out using imaging scans every two treatment cycles throughout the study. For the other outcomes the trial set out to measure — specifically how long it took for the disease to progress and how long participants survived overall — the reported data shows that no numerical results were submitted to ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00596830 · results posted 3 December 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 342 people in the figitumumab plus chemotherapy group and 339 people in the chemotherapy-only group — a total of 681 participants. The trial was measuring whether adding a drug called figitumumab (a targeted medicine) to a standard two-drug chemotherapy combination (paclitaxel and carboplatin) made a difference for people with a type of lung cancer. The main thing the trial was set up to measure was how long participants lived overall (called "overall survival"). Several secondary things were also measured, including how long it took for the cancer to get worse, how many participants' tumours shrank or disappeared, and participants' quality of life. The reported data shows that the median overall survival — meaning the point at which half of participants in each group had passed away — was 8.6 months in the figitumumab-plus-chemotherapy group and 9.8 months in the chemotherapy-only group. For progression-free survival (how long it was before the cancer got worse or a participant died), the reported figures were 4.7 months in the figitumumab group and 4.6 months in the chemotherapy-only group. The reported data also shows that 33.0% of participants in the figitumumab group and 34.5% in the chemotherapy-only group had their tumour shrink or disappear by a measurable amount. For the three quality-of-life measures included in the trial, no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00855894 · results posted 1 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people, all of whom received a combination of two drugs: pertuzumab and erlotinib. Eight participants were recorded as completing the study, while 33 did not complete it. The trial was primarily measuring whether a special type of scan — an FDG-PET scan, which looks at how active tumour cells are — showed a reduction in activity after 56 days of treatment. It also looked at how long participants went without their disease getting worse (progression-free survival), how long they lived overall, and what proportion showed a measurable reduction in tumour size or had their disease stay stable. The reported data shows that across all 41 participants, 19.5% showed a PET scan response at day 56 (meaning their scan activity dropped by at least 20%). When the participants were split into two subgroups based on a genetic feature of their tumour (called EGFR mutation status), the reported response rate was 66.7% in one subgroup and 8.7% in the other — though it is not specified in the data which figure belongs to which subgroup. For the secondary outcomes, the reported data shows that the median time before disease progression was 1.9 months, and the median overall survival was 8.7 months. Around 7.3% of participants had a measurable reduction in tumour size meeting the study's definition of an objective response, and 31.7% had their disease remain stable or better at day 56. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01100931 · results posted 4 April 2013
According to the results reported on ClinicalTrials.gov, this trial involved two phases and a total of 41 participants — 22 people in Phase I and 19 people in Phase II. The trial was testing a drug delivered through a continuous drip into a vein over 72 hours, repeated every 21 days. Phase I was designed to find the highest dose that could be given without causing too many serious side effects (called the "maximum tolerated dose"), while Phase II looked at how many participants' tumours shrank or disappeared in response to that dose. The reported data shows that in Phase I, the research team tested six increasing dose levels, ranging from 3.6 mg/m² up to 12 mg/m². The maximum tolerated dose — meaning the highest dose considered manageable based on side effects seen in the first treatment cycle — was reported as 10 mg/m², and this became the dose used in Phase II. For Phase II, the primary measure of tumour response showed that 0 participants had a complete response (full disappearance of measurable tumour) and 2 participants had a partial response (tumours shrinking by at least 30%). Regarding adverse events (unwanted or unexpected health effects), the reported data shows that all 22 participants in Phase I and all 19 participants in Phase II experienced at least one adverse event, though the detailed breakdown of what those events were is listed separately in the adverse events section of the trial record and is not reproduced here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00064350 · results posted 28 November 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 342 participants across three groups. Two groups — 59 people and 46 people respectively — went through an initial treatment phase and were then randomly assigned to receive either sorafenib (a tablet-based treatment) or a placebo (a dummy pill with no active ingredient). A third, larger group of 237 people received only the initial induction treatment and were not part of the random assignment. The trial was measuring how many people's cancer remained stable or showed a response two months after being randomly assigned, and also tracked how long people lived without their disease getting worse, and how long they survived overall. The reported data shows that for the main (primary) outcome — the number of people whose disease was stable or had responded two months after random assignment — 27 out of 50 people in the sorafenib group and 7 out of 31 people in the placebo group met this measure. For the secondary outcomes, the reported data shows that the median time before the disease progressed or death occurred (known as "progression-free survival") was 3.3 months in the sorafenib group and 2.0 months in the placebo group. The median overall survival — meaning the point at which half the participants in each group had died and half were still alive — was reported as 13.7 months for the sorafenib group and 9.0 months for the placebo group. In terms of best overall response recorded during the trial, 1 person in each group showed a partial response (some shrinkage), 28 in the sorafenib group and 6 in the placebo group had stable disease, and 20 in the sorafenib group and 24 in the placebo group had progressive disease. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00094094 · results posted 16 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, all of whom received a medicine called axitinib. None of the 32 participants were recorded as having "completed" the study — all 32 were listed under "not completed," though the data does not explain the reasons for this in the results section. The trial was primarily measuring how many participants showed an "objective response" — meaning their tumours either disappeared entirely or shrank by at least 30% and stayed that way for at least four weeks, as assessed by standard imaging criteria. The reported data shows that approximately 9.4% of participants met the criteria for an objective response to axitinib. For the secondary measures, the reported data shows that the middle point for progression-free survival (the time before a participant's cancer grew or they passed away) was 148 days. Among those who did show a response, the reported duration of that response was 252 days on average. The reported overall survival figure — the time from starting treatment until death from any cause — was 450 days. Two additional measurements related to drug levels in the blood and certain proteins in the blood were planned but no results were reported in the data for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00871403 · results posted 16 February 2012
According to the results reported on ClinicalTrials.gov, this trial compared three treatment combinations in people with a type of cancer (likely lung cancer based on the medicines used). A total of 106 participants entered the main combination treatment phase: 9 received pazopanib 600 mg plus pemetrexed, 62 received pazopanib 800 mg plus pemetrexed, and 35 received cisplatin plus pemetrexed. The trial's main goal was to measure "progression-free survival" — that is, how long participants went without their disease getting worse or dying. It is worth noting that the trial was stopped early before it finished enrolling its planned number of participants, which the researchers acknowledged affected what could be learned from the results. The reported data shows that, for the main measure, participants in the pazopanib 800 mg plus pemetrexed group went a median (middle value across the group) of 25.0 weeks before their disease progressed or they died, compared with 22.9 weeks in the cisplatin plus pemetrexed group. For the secondary measure looking at tumour response, the reported data shows that 14 out of 62 participants (about 14%) in the pazopanib 800 mg group and 12 out of 35 participants (about 12% as reported) in the cisplatin group had their tumour shrink by at least 30% or disappear completely. No participants in either group had a complete disappearance of all target tumour areas. Overall survival — how long participants lived in total — was not able to be estimated because the trial closed earlier than planned, so that data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00923949 · results posted 14 February 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant in the pioglitazone group, and that same one participant completed the study. The trial was set up to look at whether pioglitazone — a medication — had any measurable effect on certain biological markers (chemical signals measured in tissue samples) in tumour and surrounding tissue, as well as on the metabolic activity of tumours using a type of scan called a PET scan. The reported data shows that for most of the outcomes the trial set out to measure — including changes in tumour tissue markers, pre-cancerous tissue markers, and scan-based activity — no numerical results were submitted to ClinicalTrials.gov. In other words, those figures were not reported. The only number provided was for the secondary outcome tracking adverse events (unexpected health changes noted during the trial): the reported data shows that 1 out of 1 participant had at least one adverse event recorded, though the specific details of those events sit in a separate section of the trial record that was not included in the data provided here. Because only a single person took part and most outcome data was not reported, the information available from this trial record is very limited and does not allow for any broader conclusions to be drawn. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00723957 · results posted 17 October 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 197 people with cancer — 98 in a group receiving a drug combination of ixabepilone plus carboplatin, and 99 in a group receiving paclitaxel plus carboplatin. The trial was primarily measuring "progression-free survival" — that is, how long participants went without their disease getting worse or dying — specifically in those whose tumours tested positive for a protein called βIII-tubulin. The trial also looked at the same measure in people whose tumours tested negative for that protein, across all participants combined, and at other measures such as tumour response rates and side effects. The reported data shows that in the main focus group (those with βIII-tubulin positive tumours), the median time without disease progression was 4.27 months in both the ixabepilone group and the paclitaxel group. In participants whose tumours tested negative for that protein, the reported figures were 5.78 months for the ixabepilone group and 5.32 months for the paclitaxel group. Across all participants combined, the reported figures were 5.29 months and 5.13 months respectively. For tumour response (the proportion of participants whose tumours shrank meaningfully or disappeared), the reported data shows varying percentages across different subgroups, ranging from approximately 17% to 29% depending on the group and subgroup examined. The reported data also shows that during the trial, 85 participants in the ixabepilone group and 87 in the paclitaxel group experienced adverse events (unwanted symptoms or medical problems) considered possibly related to the study drugs. Serious adverse events were reported in 27 and 28 participants respectively, and nerve-related side effects (peripheral neuropathy) were recorded in 35 participants in the ixabepilone group and 54 in the paclitaxel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00148798 · results posted 4 October 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,125 people with cancer — 557 in a group that received cetuximab (a targeted medicine) combined with chemotherapy, and 568 who received chemotherapy alone. The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked a number of secondary measures including how long it took for the disease to get worse, how many participants' tumours shrank or disappeared, disease control rates, and participants' own ratings of their quality of life. The reported data shows that the median overall survival — that is, the point in time by which half the participants in each group had passed away — was 11.3 months in the cetuximab plus chemotherapy group and 10.1 months in the chemotherapy-alone group. For progression-free survival (how long until the disease worsened or death occurred), both groups reported the same figure of 4.8 months. The proportion of participants whose tumours showed a confirmed shrinkage or disappearance was reported as 36.4% in the cetuximab combination group and 29.2% in the chemotherapy-alone group. Disease control (which also includes those whose disease stayed stable) was reported at 72.5% and 71.5% respectively. The reported data also shows quality-of-life scores, measured using a standard questionnaire where higher numbers indicate better wellbeing, were recorded at multiple time points during the trial. Overall health status scores across the time points ranged from roughly 46 to 55 out of 100 in the cetuximab combination group and from roughly 46 to 52 in the chemotherapy-alone group. Social functioning scores ranged from approximately 58 to 67 in the cetuximab combination group and from approximately 65 to 67 in the chemotherapy-alone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00457392 · results posted 2 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 960 people with cancer — 480 in each group. One group received a combination of two medicines (sunitinib plus erlotinib) and the other received erlotinib alone. The trial was primarily measuring how long participants lived overall, and also tracked a number of secondary measures including how long it took for the cancer to get worse, whether tumours shrank, how long any shrinkage lasted, the chance of surviving one year, and participants' self-reported quality of life. The reported data shows that, for overall survival (how long participants lived from the start of the study), the sunitinib-plus-erlotinib group had a reported median of 9.0 months, compared with 8.5 months for the erlotinib-alone group. (A "median" means half the participants in that group lived longer than this figure and half lived shorter.) For progression-free survival — the time before the cancer worsened or death occurred — the reported figures were 15.5 weeks for the combination group and 8.7 weeks for the erlotinib-alone group. The reported data shows that around 10.6% of participants in the combination group and 6.9% in the erlotinib-alone group had their tumours shrink to a measurable degree. Among those whose tumours did shrink, that response lasted a reported 39.6 weeks in the combination group and 32.3 weeks in the erlotinib-alone group. The reported one-year survival probability was 40% for the combination group and 37% for the erlotinib-alone group. Quality-of-life scores (measured on a scale where 1.000 is the best possible health state) were also reported but varied across different time points; baseline scores were reported as 0.750 and 0.716, with later scores of 0.615 and 0.598 for the combination and erlotinib-alone groups respectively. It is worth noting that no participants were recorded as having formally "completed" the study, and the data does not explain why — this detail was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00664105 · results posted 22 March 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people, all of whom received a combination of chemotherapy and radiotherapy. The trial was measuring how long participants lived overall, how their tumours responded to treatment, how long it took for the disease to get worse, and what unwanted side effects occurred. Of the 63 people who started, 39 completed the study and 24 did not. The reported data shows that the median overall survival — meaning the point at which half the participants had passed away and half were still alive — was 11 months. For tumour response, the results reported 6 participants whose tumours disappeared completely, 33 whose tumours shrank by 30% or more, 5 whose tumours neither shrank enough to count as a response nor grew enough to count as worsening, and 13 whose tumours grew by 20% or more. The reported median time to disease progression — that is, the midpoint at which half the participants' disease had begun to worsen — was 5 months. Regarding unwanted events, the reported data shows that 11 participants experienced mild (Grade 1) events, 19 experienced moderate (Grade 2) events, 35 experienced severe (Grade 3) events, 12 experienced life-threatening (Grade 4) events, and 3 experienced events graded as death related to an adverse event (Grade 5). Note that individual participants may have experienced events across more than one grade, so these numbers reflect the count of participants at each severity level rather than separate individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00609518 · results posted 15 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 111 people in total — 54 in one group and 57 in the other. Both groups received a chemotherapy medicine called pemetrexed, but they differed in how the supporting vitamins and steroids (medicines given alongside chemotherapy to reduce side effects) were scheduled: one group followed a standard schedule and the other followed a simplified schedule. The trial was comparing these two approaches, mainly by looking at how many participants experienced serious or severe unwanted effects linked to the drug. The reported data shows that, for the primary measure — the number of participants who experienced severe or life-threatening drug-related side effects (graded 3 or 4 on a scale where 3 is severe and 4 is life-threatening) — 15 out of 54 people were recorded in the standard schedule group, and 18 out of 57 in the simplified schedule group. For the secondary measures, the reported data shows that the proportion of participants whose tumours showed a measurable response (either complete or partial shrinkage) was about 12% in the standard group and about 6% in the simplified group. The reported median overall survival — that is, the midpoint of how long participants lived from the start of the study — was 8.2 months in the standard group and 9.2 months in the simplified group. The reported median time before the disease progressed or worsened (progression-free survival) was 3.7 months in the standard group and 3.8 months in the simplified group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00549328 · results posted 27 January 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom received a daily oral dose of pazopanib (800 mg). The trial was designed to look at how a cancer medication called pazopanib affected people's tumours, specifically measuring whether tumours shrank or disappeared, how long participants went without their disease getting worse, how long participants lived overall, and changes in certain proteins in the blood and tumour tissue that might respond to the medication. The reported data shows that no results were actually recorded for any of the outcome measures — neither the main measure (whether tumours shrank or disappeared) nor any of the additional measures (disease control, time without progression, overall survival, or biomarker levels). According to the results reported on ClinicalTrials.gov, this was because the study was ended early. All 14 participants who started the trial did not complete it, and the trial organisers stated that no formal analyses were carried out as a result of the early termination. Because the study closed before it could be completed, the reported data shows no numerical findings to describe for any of the planned measurements. The reasons for early termination are not detailed in the submitted results data, and any biomarker protein levels that were intended to be collected were also not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00494026 · results posted 17 November 2009
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two chemotherapy drugs — pemetrexed and carboplatin — given to people with a type of cancer being treated in this study. Only 4 people were enrolled in the single treatment group. None of the 4 participants completed the study, and all 4 were recorded as not having completed it. The trial was measuring how many patients' tumours shrank or disappeared (called the overall response rate), as well as how long participants lived without their disease getting worse, how long they survived overall, and how long any response to treatment lasted. The reported data shows that no results were recorded for the main outcome — the proportion of patients whose tumours shrank or disappeared — or for the secondary outcomes measuring survival time, time without disease progression, or duration of response. These figures were simply not reported in the data submitted to ClinicalTrials.gov. The only numbers provided relate to a measure called "pharmacology toxicity," which tracked side effects using a grading scale from 0 to 5. The reported data shows individual values of 1 recorded across 10 separate toxicity categories, each for 1 participant, though the specific types of side effects linked to these scores were not detailed in the submitted data. Because so few people took part and the trial did not complete as planned, the dataset is very limited. The reported data shows that most of the outcomes the trial set out to measure were never submitted with numerical results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00363415 · results posted 6 October 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 453 people in the pemetrexed plus carboplatin group and 455 people in the etoposide plus carboplatin group — a total of 908 participants. The trial was comparing two different chemotherapy combinations in people with a type of lung cancer called small cell lung cancer. The main thing the trial was measuring was how long participants lived overall (called "overall survival"). It also measured how long it took before the cancer showed signs of growing again, and how participants rated their own quality of life using a standard questionnaire. The reported data shows that, on average, participants in the pemetrexed plus carboplatin group lived for 8.1 months from the time they enrolled, while those in the etoposide plus carboplatin group lived for 10.6 months. When looking at how long it was before the cancer appeared to progress, the reported figures were 3.8 months for the pemetrexed plus carboplatin group and 5.4 months for the etoposide plus carboplatin group. For quality of life, both groups started with similar scores on the questionnaire (around 87–88 out of a possible 136, where higher means better). The reported changes from that starting score across treatment cycles were small in both groups — generally less than 2 points in either direction — which is below the 5-point threshold the researchers described as a meaningful difference. The reported data also includes results broken down by subgroups such as sex, age, and other baseline characteristics, with overall survival figures varying across these subgroups. For two particular subgroups, the statistical analysis could not be fully completed for the etoposide plus carboplatin group, so only participant numbers were reported for those. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.