Phase 3 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 aged 18 years or older and under 80 years old, of any gender.
• People diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC), confirmed through a tissue or cell sample test.
• People whose cancer has a specific type of gene change in the EGFR gene (such as exon 19 deletions or L858R mutations, either alone or alongside other EGFR changes).
• People who have not yet received any systemic treatment (such as chemotherapy, targeted therapy, or immunotherapy) for their locally advanced or metastatic NSCLC.
• People who have at least one measurable area of cancer that can be tracked using standard imaging criteria.
• People who are in reasonably good general health, able to carry out daily activities with little or no limitation, whose condition has been stable for at least 2 weeks before the study, and whose life expectancy is at least 3 months.
• People with adequate bone marrow, liver, kidney, and blood clotting function.
• People who are willing and able to use reliable contraception from the time of signing consent until 3 months after the last dose of the study drug; women who could become pregnant must have a negative pregnancy test within 7 days before the first dose.
• People who have recovered from most side effects of any previous cancer treatments (with minor exceptions for hair loss and certain nerve-related side effects from platinum-based therapy).
• People who are able to understand and voluntarily sign a consent form agreeing to take part.
• People who are able to follow all study requirements.

Who may not be able to join:

• People who have previously been treated with an EGFR inhibitor (a targeted drug that blocks the EGFR protein).
• People who have previously received any systemic anti-cancer therapy, including targeted therapy, biological therapy, or immunotherapy.
• People who received standard chemotherapy within 28 days before the first study dose, or traditional Chinese medicine cancer treatments within 7 days before the first study dose.
• People who received radiation therapy covering more than 30% of the bone marrow, or extensive radiation therapy, within 28 days before the first study dose; or limited-field radiation therapy or palliative bone radiation within 7 days before the first study dose.
• People with fluid build-up around the lungs or abdomen that cannot be adequately controlled.
• People who had major surgery within 28 days before the first study dose.
• People who are currently taking, or have taken within 14 days before the first dose, certain medications or herbal supplements known to strongly affect how the body processes the study drug (specifically, strong inhibitors or inducers of a liver enzyme called CYP3A4) (confirm with trial site).
• People who are taking medications known to affect the heart's electrical rhythm (QTc interval) or that may cause a fast heartbeat, and who would need to continue these during the study.
• People who have taken part in another clinical trial within 28 days before the first study dose (non-interventional studies may be excepted — confirm with trial site).
• People whose NSCLC is confirmed to be, or predominantly made up of, a type called squamous cell carcinoma.
• People who have brain or membrane-lining metastases (cancer spread to the brain or surrounding tissue) that are causing symptoms.
• People who have spinal cord compression caused by their tumour.
• People with serious digestive system problems that may affect the ability to swallow, absorb, or process the study drug.
• People with certain heart conditions, including a prolonged QTc interval on three separate heart tracings, significant abnormal heart rhythms, other factors that increase risk of heart rhythm problems, or a weakened heart pump function (ejection fraction below 50%).
• People with active HIV, syphilis, hepatitis C, or hepatitis B infection (people who carry hepatitis B or C without symptoms may be assessed separately — confirm with trial site).
• People with a history of a type of lung scarring condition (interstitial lung disease), drug-related lung damage, or radiation-related lung inflammation that required steroid treatment, or who currently show signs of active lung inflammation of this type.
• People who have previously had an allogeneic bone marrow transplant (a transplant using donor bone marrow).
• People who are pregnant or breastfeeding.
• People with any other unstable medical condition that could affect safety or ability to follow the study requirements.
• People with a known allergy or sensitivity to the study drug or similar compounds or their ingredients.

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