Study on Zipalertinib vs. Placebo for Early Stage Non-Small Cell Lung Cancer with Uncommon EGFR Mutations After Tumor Removal

Inclusion Criteria

• Diagnosed with primary non-small cell lung cancer (NSCLC) with non-squamous cell type.
• Have uncommon EGFR mutations confirmed by a certified laboratory test.
• Had a brain scan (MRI or CT) before or after surgery.
• Complete surgical removal of the lung cancer, with no remaining cancerous tissue.
• Classified as Stage IB, IIA, IIB, or IIIA after surgery.
• Fully recovered from surgery at the time of joining the study.
• In good general health with an ECOG performance status of 0 or 1.
• Have a tumor tissue sample available for testing.

Exclusion Criteria

• Currently participating in another clinical trial or receiving an investigational drug.
• Have taken zipalertinib or any other EGFR inhibitor before.
• Have had radiation therapy for the current lung cancer.
• Have received any prior systemic cancer treatment for NSCLC.
• Have had major surgery within 4 weeks before starting the study treatment.
• Taking medications that affect the liver enzyme CYP3A4 within 7 days before starting the study.
• Have only had segmentectomies or wedge resections.
• Have a history of lung disease or inflammation.
• Have significant heart problems.
• Cannot swallow tablets or have digestive issues affecting absorption.
• Have a history of other cancers, except for certain treated skin or in-situ cancers.
• Have unstable or untreated hepatitis B, C, or HIV.
• Have active bleeding disorders.
• Have allergies to the study drugs or their components.
• Cannot take certain supplements during treatment.