Phase 3 Study of Taletrectinib vs Placebo as an Additional Treatment in ROS1 Positive Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Diagnosed with stage IB, II, or IIIA non-small cell lung cancer (NSCLC) based on specific medical criteria.
• Have a confirmed ROS1 genetic marker in the primary tumor.
• Provide a tumor sample for further testing.
• Be 18 years or older (or 20 years or older if required by local regulations).
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have had surgery to remove the lung tumor, with no remaining cancer at the edges of the removed tissue.
• Fully recovered from surgery, which must have been done at least 4 weeks but no more than 16 weeks ago if no additional chemotherapy was given, or at least 4 weeks but no more than 30 weeks ago if chemotherapy was given.
• If chemotherapy was given after surgery, the last dose must have been at least 7 days before starting the study, and any side effects must have resolved to baseline or mild levels.

Exclusion Criteria

• Have received certain cancer treatments before, such as radiation therapy after surgery or more than 4 cycles of standard chemotherapy.
• Have received any other additional cancer treatments for NSCLC, except for a limited amount of immune therapy.
• Have had major surgery within 4 weeks before starting the study.
• Have had only limited surgery for the lung tumor, unless specific conditions are met.
• Have received experimental treatments for other conditions within 6 months before starting the study.
• Have other specific genetic mutations in the cancer.
• Have had other cancers, unless they were treated and have not returned for over 3 years.
• Have significant heart disease or uncontrolled high blood pressure.
• Have ongoing heart rhythm problems or are taking medications that affect heart rhythm.
• Have active infections, including hepatitis or HIV.
• Have a history of lung diseases that required steroid treatment.
• Are using certain medications that affect how the body processes drugs within 14 days before starting the study.