Study on Osimertinib and Savolitinib for Advanced Lung Cancer with Specific Genetic Changes

Inclusion Criteria

• Must be 18 years or older (20 years or older in Japan).
• Have advanced non-small cell lung cancer (NSCLC) with specific genetic changes (EGFR mutation) that cannot be cured with surgery or radiation.
• Cancer must have worsened after taking osimertinib.
• Have a genetic change called MET amplification or overexpression confirmed by specific tests.
• Provide a tumor sample for testing or be willing to provide a new sample.
• Have at least one measurable tumor that has not been treated with radiation or biopsied recently.
• Have only received osimertinib as prior treatment for advanced cancer.
• Have adequate blood cell counts and organ function.
• Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
• Women must use effective contraception and not be pregnant or breastfeeding.
• Men must use barrier contraception if their partner is of childbearing potential.

Exclusion Criteria

• Have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
• Have digestive issues that affect medication absorption.
• Have certain heart conditions or uncontrolled high blood pressure.
• Have had recent major surgery or radiation therapy.
• Have severe or uncontrolled diseases or infections.
• Have other active cancers or a history of invasive cancer within the last 5 years, except for certain non-threatening cancers.
• Have brain or spinal cord issues unless stable and not requiring steroids.
• Have a history of lung disease requiring steroids.
• Have liver disease or cirrhosis.
• Have been treated with other similar drugs before osimertinib.
• Are taking medications that affect the liver enzyme CYP3A4 or CYP1A2.
• Are participating in another clinical trial with similar treatments.
• Have allergies to the study drugs or similar medications.