Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with non-small cell lung cancer (NSCLC) that has a specific gene change called a "sensitizing EGFR mutation," and your cancer has gotten worse while on a drug called osimertinib (alone or combined with other treatments) as your most recent treatment — any number of prior treatments is allowed.
• Your cancer has been tested (using a tissue sample or blood test) and found to have a change called "MET amplification," and that testing was done after your cancer worsened on osimertinib, in a certified laboratory.
• You have been assigned to this specific sub-study (called S1900G) through the LUNGMAP master protocol.
• Your cancer can be seen and measured or tracked on a CT or MRI scan, with scans completed within the required time window before joining.
• You have had a brain CT or MRI scan within about 6 weeks before joining to check for cancer spread to the brain.
• If you have brain metastases with symptoms, your neurological condition must be stable, and any steroid doses must be stable or decreasing for at least 5 days before joining.
• You have mostly recovered from side effects of previous treatments (side effects must be mild or gone), except for hair loss or skin colour changes, which are allowed.
• You are able to swallow tablets whole.
• Your blood counts and organ function (blood cells, liver, kidneys, and pancreas) are within acceptable levels based on recent blood tests taken within about 4 weeks before joining.
• Your heart rhythm (measured on an ECG) shows a specific reading (QTcF) of 470 milliseconds or less, tested within 4 weeks before joining.
• Your overall health and ability to carry out daily activities is rated at a good level (score of 0 or 1 on a standard medical scale) within 4 weeks before joining.
• A urine test shows little to no protein in your urine within 4 weeks before joining.
• Your blood clotting levels are within an acceptable range within 4 weeks before joining (unless you are already on blood-thinning medication).
• If you are living with HIV, you must be on effective HIV treatment and have an undetectable viral load within the past 6 months.
• Your heart function is rated at an acceptable level (Class 2B or better on a standard heart health scale).
• You are willing to have blood samples taken for cancer DNA testing and may be asked to contribute additional samples to a research bank (with your permission).
• You have been fully informed about the study and have signed a consent form; if you have difficulty making decisions, a legally authorised representative may sign on your behalf, as long as your condition does not make safe participation impossible.

Who may not be able to join:

• You have previously received a type of medication that targets blood vessel growth (anti-VEGF or VEGFR inhibitor) or a MET inhibitor drug.
• You have received any anti-cancer drug (other than osimertinib) within 3 weeks before joining — note that osimertinib may be continued up until the day before starting study treatment.
• You have received radiation therapy within 2 weeks before joining.
• You are planning to receive other cancer treatments (chemotherapy, immunotherapy, biological therapy, or hormonal therapy) at the same time as this study's treatment.
• You have had major surgery within 2 weeks before joining, or have not fully recovered from a previous surgery.
• You have received a live vaccine within 4 weeks before joining (standard approved COVID-19 vaccines are acceptable).
• You are currently taking, or have taken within the past week, certain medications or supplements that can interfere with how the study drugs work in your body — including St. John's Wort — or drugs known to affect heart rhythm (confirm with trial site for the full list).
• You have uncontrolled high blood pressure within 4 weeks before joining.
• You have or have had another cancer that could interfere with the safety or results of this study, in your doctor's opinion.
• You are pregnant or breastfeeding; if you could become pregnant or father a child, you must agree to use effective contraception during the study.

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