Study on Adagrasib and SRS for Patients with KRAS G12C-Mutated Lung Cancer with Untreated Brain Metastases

Inclusion Criteria

• Must provide written consent and authorization for the release of personal health information.
• Must be 18 years or older.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have stage IV non-small cell lung cancer (NSCLC) or metastatic recurrence after earlier treatment.
• Must have a KRAS G12C mutation, confirmed by local testing.
• Must have brain metastases with at least one untreated lesion measuring at least 2mm, no more than 10 brain metastases, and no single metastasis larger than 3 cm.
• Must have brain metastases that can be treated with SRS or have already been treated with SRS within 3 weeks prior to the study.
• Must not have contraindications to SRS and must be able to pause anticoagulation if needed.
• May have received up to 2 prior lines of systemic therapy.
• Must have adequate organ function as shown by specific blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
• Men must agree to use effective contraception if sexually active with women of childbearing potential.
• HIV-positive patients must have an undetectable viral load.
• Patients with hepatitis B or C must have the virus under control or cured.
• Must be able to understand and comply with study procedures.

Exclusion Criteria

• Previous treatment with a KRAS G12C inhibitor.
• Active infection requiring treatment, except for controlled HIV or hepatitis.
• Uncontrolled or significant recent illness.
• Prolonged QTc interval or history of Long QT Syndrome.
• Currently receiving radiation for non-brain lesions.
• Need for medications that strongly affect the CYP3A enzyme and cannot be changed.
• Treatment with an investigational drug within 28 days before the study.
• Pregnant or breastfeeding women.
• Other cancers that could interfere with the study.