Printed from Voxsanity (voxsanity.com.au) — NCT06530719 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06530719
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 aged 18 years or older.
- People who have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by laboratory tissue testing, classified as stage IB to IIIB according to standard cancer staging guidelines.
- People who had surgery to remove their lung cancer, then received a targeted therapy drug (an EGFR TKI — a type of tablet-based cancer treatment) after surgery, and whose cancer came back or got worse more than 3 months after finishing that adjuvant treatment course.
- People whose cancer was previously confirmed by a qualified laboratory test to have a specific genetic change called an EGFR sensitive mutation, found in either a tumour tissue sample or a blood sample.
- People who are generally well enough to carry out daily activities with little or no limitation (assessed using a standard medical scale called ECOG, scored 0 or 1), whose condition has not declined in the previous 2 weeks, and who are expected to live at least 12 weeks.
- People who have at least one tumour that can be clearly measured by CT or MRI scan — the tumour must be at least 10 mm at its longest point (or at least 15 mm for lymph nodes), and this measurement must be taken at least 14 days after any diagnostic biopsy if only one tumour is present.
- People whose blood clotting test results are within acceptable ranges within 7 days before starting treatment (specific values to be confirmed with the trial site).
- Women of childbearing potential who have had a negative pregnancy test before starting treatment, are not breastfeeding, and are willing to use appropriate contraception from the time of screening until 6 months after stopping the study treatment — or women who can be confirmed as post-menopausal or permanently sterilised based on specific medical criteria.
- Male participants who are willing to use barrier contraception (condoms) from the time of screening until 6 months after stopping the study treatment.
- People who voluntarily agree to take part and sign a written consent form.
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 who have already received any of the following treatments after their cancer progressed: platinum-based or other chemotherapy; another EGFR TKI targeted therapy; chest radiotherapy; any lung cancer immunotherapy; anti-angiogenic drugs such as bevacizumab; major surgery or significant injury within 4 weeks before the first study dose; or who are expected to need major surgery during the study; large-area or bone marrow radiotherapy (more than 30%) within 4 weeks before the first dose; or certain medications that strongly interact with a liver enzyme called CYP3A4 within 7 days before the first dose.
- People whose cancer has only come back in one local area and for whom standard radical chest radiotherapy and chemotherapy would be a suitable treatment option.
- People who have other serious medical conditions or a separate cancer requiring standard treatment or major surgery within 2 years of starting the study.
- People who have had serious heart or brain blood vessel problems within the 6 months before joining, including stroke, mini-stroke (TIA), heart attack, unstable angina, moderate-to-severe heart failure, or serious irregular heart rhythms that cannot be adequately controlled.
- People who have a history of scarring or inflammation of the lung tissue (interstitial lung disease), including lung damage caused by previous drugs or radiation treatment that required steroid therapy, or who currently show signs of active interstitial lung disease.
- People with wounds that are not healing, active stomach ulcers, or bone fractures.
- People who have had another type of cancer in the 5 years before joining the trial — except for certain fully treated early-stage cancers such as cervical carcinoma in situ, certain skin cancers, localised prostate cancer after radical surgery, or breast ductal carcinoma in situ.
- People who still have side effects from previous cancer treatment rated above a mild level (above grade 1 on a standard scale) that have not resolved before starting the study — except for hair loss or grade 2 nerve-related side effects from prior chemotherapy.
- People who have cancer that has spread to the spine or brain, unless it is causing no symptoms, is stable, and has not required steroid treatment for at least 2 weeks before starting the study.
- People with any serious or poorly controlled overall health condition, such as a tendency to bleed actively or an active infection, as assessed by the treating doctor.
- People who have ongoing severe nausea, vomiting, or digestive tract conditions, who are unable to swallow tablets, or who have had major bowel surgery that may prevent the study drug (osimertinib) from being properly absorbed.
- People whose heart electrical activity (ECG) test results show any of the following: an average corrected heart rhythm interval (QTc) above 470 milliseconds; significant abnormalities in heart rhythm or electrical conduction patterns; risk factors for abnormal heart rhythms such as heart failure, low potassium, inherited heart rhythm conditions, a family history of certain heart conditions, or use of medications that affect heart rhythm; or a measurement of the heart's pumping function (left ventricular ejection fraction) at or below 40%.
- People whose blood test results show that bone marrow, liver, or kidney function does not meet the required levels (specific thresholds to be confirmed with the trial site).
- Women who are breastfeeding or who have a positive pregnancy test within 3 days before the first study dose.
- People who have protein in their urine above a certain level, confirmed by a 24-hour urine collection test showing more than 1 gram of protein.
- People who have had an allergic reaction to osimertinib or to drugs that are chemically similar to it.
- People with serious or uncontrolled eye conditions that the treating doctor considers may increase safety risks.
- People who the investigator believes are unlikely to follow the study procedures and requirements.
- People who the investigator believes have any condition that could put their safety at risk or affect the reliability of the study results.
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.
Contact this trial
Phone: +86 18806529092
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jin Ying
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 May 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Objective remission rate evaluated by the investigator (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 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.