Phase 2 Lung Cancer Trial, Completed NCT00454194 Sponsor: Alliance for Clinical Trials in Oncology Condition: Lung Cancer
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Trial 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

According to the results reported on ClinicalTrials.gov, this trial enrolled 98 people in total — 47 in a group that received a combination of two drugs (pemetrexed plus sorafenib) and 51 in a group that received pemetrexed alone. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as a number of other outcomes including how long participants lived overall, how long before treatment had to be stopped, how long any tumour shrinkage lasted, and how many participants had serious side effects. The reported data shows that, for the main outcome, the combination group went a median of 3.4 months without their disease progressing, compared with 4.1 months in the pemetrexed-alone group. (Median simply means half the participants had a longer time and half had a shorter time.) For overall survival — how long participants lived from the time they joined the trial — the reported figures were 9.3 months for the combination group and 10.4 months for the pemetrexed-alone group. The time until treatment had to be stopped was reported as 2.0 months for the combination group and 3.1 months for the pemetrexed-alone group. For those whose tumours shrank, that shrinkage lasted a reported 7.4 months in the combination group and 8.5 months in the pemetrexed-alone group. Regarding serious side effects (graded "severe" or worse on a standard medical scale), 43 out of 47 participants in the combination group and 27 out of 51 in the pemetrexed-alone group were reported to have experienced at least one such event. The reported data shows that the proportion of participants whose tumours shrank meaningfully (a "confirmed response") was 12.8% in the combination group and 9.8% in the pemetrexed-alone group. Stable disease (tumour neither growing significantly nor shrinking enough to count as a response) was reported in 38.3% of the combination group and 45.1% of the pemetrexed-alone group, while disease that progressed despite treatment was recorded in 23.4% and 35.3% respectively. A small proportion — 25.5% in the combination group and 9.8% in the pemetrexed-alone group — were not able to be evaluated for response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Lung Cancer Trial, Completed

NCT00454194
Completed Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility 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

Who may be able to join

  • People diagnosed with a specific type of lung cancer called non-squamous cell non-small cell lung cancer (NSCLC), confirmed by lab testing of tissue or cell samples, that is at an advanced stage (Stage IIIB or IV). A mixed type called adenosquamous is also allowed, but pure squamous cell carcinoma is not.
  • People whose cancer can be measured on scans — meaning at least one tumour that is large enough to be tracked over time (at least 2 cm using standard imaging, or at least 1 cm using a spiral CT scan).
  • People who have already received one prior chemotherapy treatment for their lung cancer. Prior chemotherapy given after surgery (adjuvant chemotherapy) is allowed and does not count as that one regimen.
  • People with brain tumours that have spread from the lung cancer, as long as those were previously treated with whole brain radiation or gamma knife surgery, and steroids were stopped more than 4 weeks ago.
  • People who are generally well enough to carry out light activity (performance status 0–1 on a standard medical scale) and have a life expectancy of at least 12 weeks.
  • People whose blood test results meet specific minimum levels for white blood cells, platelets, haemoglobin, kidney function, and liver function (confirm exact values with trial site).
  • People who are able to swallow pills and take folic acid, a B12 supplement (cyanocobalamin), and a steroid called dexamethasone as part of the study.
  • People who are not pregnant or breastfeeding, and who have had a negative pregnancy test. People who could become pregnant must agree to use effective contraception during treatment and for 2 weeks after finishing.
  • People with a history of certain other treated cancers may still be eligible — including cervical carcinoma in situ, non-melanoma skin cancer, low-grade localised prostate cancer (Gleason score 6 or below), or a treated form of early breast cancer called DCIS (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose only cancer findings on scans are considered "non-measurable," such as bone lesions, fluid around the brain or spinal cord (leptomeningeal disease), fluid build-up in the abdomen (ascites), fluid around the lungs or heart, certain abdominal masses, or cyst-like lesions.
  • People who have a significant fluid build-up around the lungs that is causing breathing difficulty (grade 2 or higher) and cannot be drained before joining the study.
  • People who have previously been treated with the drugs sorafenib or pemetrexed.
  • People who have previously received treatments that specifically target a protein called VEGF or its receptor (other than bevacizumab, which is allowed).
  • People with an active serious infection.
  • People known to be HIV positive.
  • People with a history of bleeding disorders or blood clotting problems.
  • People with serious wounds, ulcers, or bone fractures that have not healed.
  • People who have had a significant injury in the past 4 weeks, or who have experienced a notable bleeding episode (grade 2 or higher, except for minor surface bleeding called petechiae) in the past 4 weeks.
  • People with uncontrolled high blood pressure despite medication, chest pain (angina), a recent heart attack (within 6 months), heart failure (within 3 months unless heart function meets a specific threshold), or an irregular heartbeat.
  • People with diabetes.
  • People who are coughing up blood (active haemoptysis).
  • People currently taking blood-thinning medication for treatment purposes (low-dose preventive anticoagulation for a port or line is allowed if blood test requirements are met).
  • People currently taking St. John's Wort, or consuming grapefruit or grapefruit juice.
  • People taking high doses of aspirin (1.3 grams or more per day for 10 or more days before or after treatment).
  • People who have not sufficiently recovered from side effects of previous treatments (hair loss is an exception).
  • People who have had major surgery in the past 4 weeks, minor surgery in the past 2 weeks, full-field radiotherapy in the past 4 weeks, or limited-field radiotherapy in the past 2 weeks.
  • People currently receiving any other cancer treatment, steroids, antiretroviral therapy, or colony-stimulating factor injections.
  • People with any other serious health condition that, in the opinion of the trial doctor, would make participation unsafe or too difficult.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2007
Est. completion
1 July 2010

Where this trial was run

🇺🇸 United States

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Progression-free Survival

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov