Study Comparing Lorlatinib and Crizotinib for First-Time Treatment in ALK-Positive Lung Cancer Patients

Inclusion Criteria

• Diagnosed with advanced ALK-positive non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery.
• Have at least one tumor outside the brain that can be measured and has not been treated with radiation.
• Brain metastases are allowed if they are not causing symptoms and do not require steroid treatment.
• Must provide a previous tumor tissue sample for analysis.
• No prior treatment for NSCLC.
• Be in good overall health with an ECOG performance status of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Be 18 years or older.
• Have adequate bone marrow, liver, kidney, and pancreatic function as determined by specific tests.
• Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

• Have spinal cord compression unless it is well-controlled.
• Have had major surgery within the last 4 weeks.
• Have received radiation therapy within the last 2 weeks, or whole brain radiation within the last 4 weeks.
• Have an active infection that requires treatment.
• Have significant heart disease or irregular heart rhythms within the last 3 months.
• Have a history of severe lung disease or lung scarring.
• Have another active cancer within the last 3 years, except for certain types of skin, cervical, thyroid, or localized prostate cancers.
• Are taking certain medications that affect how lorlatinib or crizotinib work within 12 days before starting the study.
• Have any severe medical or psychiatric conditions that could interfere with the study.
• Are participating in another clinical trial with investigational drugs within the last 2 weeks.
• Are a staff member or family member of someone involved in the study.