Phase 2 Lung Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who are 18 years of age or older, of any gender, who are willing to take part and able to follow the study requirements
• People who have been diagnosed with advanced or spread (stage IIIB, IIIC, or IV) non-small cell lung cancer (NSCLC) that cannot be removed by surgery or treated with combined chemotherapy and radiation
• People whose lung cancer has a specific genetic change called an EGFR mutation (specifically a deletion in exon 19, or an L858R change in exon 21), confirmed by laboratory testing
• People whose cancer got worse after receiving a type of targeted therapy called an EGFR-TKI, and who either responded to that treatment or had stable disease for more than 6 months on it
• People who have received no more than one chemotherapy regimen (in addition to EGFR-TKI therapy) before joining
• People whose cancer shows a specific genetic change called c-Met amplification, confirmed by either a blood test or a tumour tissue test after the most recent treatment stopped working
• People who are in reasonably good general health, as measured by a standard medical scale (ECOG score of 0 or 1), meaning they are fully active or restricted in strenuous activity but able to carry out light work
• People who have at least one measurable area of cancer that can be tracked on scans, as assessed by the study doctor
• People whose blood test results fall within acceptable ranges for blood cell counts, liver function, kidney function, and other markers as specified by the trial
• People with an expected survival of at least 3 months
• People who are able to use effective contraception from the time of signing the consent form until 3 months after the last dose of the study drug (this applies to men who could father a child and women who could become pregnant)
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose (this does not apply to women who have been surgically sterilised or have gone through menopause)

Who may not be able to join:

• People whose lung cancer has specific genetic changes called ALK fusion or ROS1 fusion
• People who have cancer that has spread to the fluid around the brain and spinal cord (leptomeningeal metastasis), or who have cancer that has spread to the brain and is causing symptoms that require increasing doses of steroids to control (note: people with brain metastases that have been stabilised may still be considered — confirm with trial site)
• People who have or have had another type of cancer, unless it was a skin cancer that was fully removed, a carcinoma-in-situ that was fully removed, or another cancer that was treated with curative intent and has been in full remission for at least 3 years
• People who received certain traditional Chinese herbal or patent medicines with anti-cancer effects within 1 week before the first dose
• People who received radiation to the lungs or whole brain within 4 weeks before the first dose, or radiation to other areas within 2 weeks before the first dose (routine palliative radiation to bones is generally excluded from this restriction — confirm with trial site)
• People who had major surgery within 4 weeks before the first dose, or who have not yet recovered from a recent major surgery
• People who have not yet recovered from the side effects of previous cancer treatments (side effects must have reduced to a mild level or resolved, except for permanent hair loss or lasting radiation damage)
• People who need to take certain strong medications that interfere with how the study drug is processed by the body (strong inhibitors or inducers of a liver enzyme called CYP3A4), within 1 week before or during the study
• People with serious uncontrolled health conditions, including uncontrolled high blood pressure, active HIV infection, active hepatitis C, or hepatitis B with high viral levels, active eye surface disease (keratitis), active tuberculosis, or serious active infection requiring antibiotics within 2 weeks before the first dose
• People with certain heart problems, including abnormal heart rhythms, a heart pump function below 50%, heart failure classified as moderately severe or severe (NYHA class 3 or above), or an abnormal measurement on a heart tracing (QTc interval above 470 ms)
• People with a history of serious lung scarring or inflammation (interstitial lung disease), or who have had radiation-related lung inflammation requiring steroid treatment
• People who have problems with blood clotting or a tendency to bleed
• People who have difficulty swallowing, have active digestive conditions, or have had major surgery on the stomach or bowel that may affect how the study drug is absorbed
• People who have had fluid build-up around the lungs, heart, or in the abdomen requiring drainage within 4 weeks before the first dose
• People with significant ongoing medical conditions judged by the study doctor to make participation unsuitable, including certain thyroid conditions, organ transplant history, serious psychiatric history, or issues with drug or alcohol use
• People with a history of pancreatitis (inflammation of the pancreas), pancreatic surgery, or known risk factors for pancreatitis
• People currently receiving clot-dissolving (thrombolytic) therapy (people on stable anticoagulant/blood-thinning medication for at least 1 week before the first dose may still be considered — confirm with trial site)
• People with a known allergy to the study drug or any of its ingredients
• Women who are pregnant or breastfeeding
• People currently enrolled in another clinical trial, or who received another experimental treatment within 2 weeks before the first dose
• People with cognitive difficulties that may limit their ability to understand or sign the consent form
• People with any other condition that the study doctor considers may make participation unsafe or unsuitable

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