Phase 3 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 a type of lung cancer called non-small cell lung cancer (NSCLC), confirmed by a laboratory test on tissue.
• After surgery, your cancer was classified as Stage IB to IIIB (a specific stage called T3N2M0), and the surgeon was able to remove all visible cancer (a "complete resection").
• You have fully recovered from your surgery and any standard follow-up treatment before joining the trial.
• A central laboratory has confirmed that your tumor has a specific genetic marker called "ALK positive."
• Your doctor expects you to live for at least one more year.
• You are generally healthy enough to carry out daily activities with little or no limitation (measured by a standard scale called ECOG, scoring 0 or 1).
• Your blood counts, liver function, kidney function, and blood clotting results all meet the required levels set by the trial (confirm specific numbers with the trial site).
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the trial.

Who may not be able to join:

• You are currently taking part in another clinical trial involving an experimental drug or device within the past 4 weeks (observation-only studies may be allowed — confirm with trial site).
• Your cancer could not be fully removed by surgery, or there were cancer cells left at the edges of the removed tissue, cancer spread beyond the lymph nodes, or you only had a small portion of lung removed (such as a wedge or segment).
• Your tumor is located at the very top of the lung in a specific area called the superior sulcus (also known as a Pancoast tumor).
• You had surgery to remove your entire right lung.
• You have had another type of cancer in the past 5 years, unless it is a cancer that has been or is expected to be fully cured.
• You have previously received cancer treatments such as chemotherapy, radiation, targeted therapy, or immunotherapy for your lung cancer — except for standard platinum-based chemotherapy given after surgery.
• You had a major operation within 3 weeks before starting the trial.
• You have taken certain traditional Chinese medicines with anti-tumor properties within the past 14 days (confirm with trial site).
• You have taken certain medications that strongly affect how the body processes drugs (specific enzyme inhibitors or inducers called CYP3A-related drugs) within the past 14 days (confirm with trial site).
• You have a serious heart or cardiovascular condition.
• You have a known allergy to a yellow food dye called Tartrazine, which is used in the 100mg capsules in this trial.
• You have a serious active infection, a lung inflammation condition (such as interstitial lung disease), or another serious illness within the past 2 weeks.
• You have an active HIV infection or a positive test for syphilis.
• You have active hepatitis B, hepatitis C, or active tuberculosis.
• You have a significant stomach or gut condition that could affect how your body absorbs the study medication.
• Your doctor or the trial team feels there are other reasons you may not be suitable for this trial (confirm with trial site).

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