Phase 2 Study of VS-7375 for Patients with KRAS G12D-Mutated Non-Small Cell Lung Cancer

Inclusion Criteria

• Have advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
• Have cancer that can be measured using standard medical criteria.
• Have a confirmed KRAS G12D mutation in the cancer cells.
• 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 good organ function based on medical tests.
• Have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor for advanced cancer.
• Have cancer that has progressed during or after the last treatment.

For patients with 2nd or 3rd line treatment:

• Have received at least 1 but no more than 2 previous treatments for advanced NSCLC.

For patients with 2nd to 4th line treatment and brain metastases:

• Have received at least 1 but no more than 3 previous treatments for advanced NSCLC.
• Have brain metastases that are not causing symptoms and have not been treated.
• Have at least one untreated brain tumor that can be measured and is between 0.5 cm and 3 cm in size.

Exclusion Criteria

• Have other common RAS mutations in addition to KRAS G12D.
• Have received any cancer treatment within 4 weeks before starting the study treatment.
• Have had major surgery within 4 weeks before starting the study treatment.
• Have had radiation therapy within 1 week before starting the study treatment.
• Have a history of lung disease caused by medication.
• Have previously received a direct RAS inhibitor.
• Have untreated or symptomatic cancer spread to the brain.
• Are taking certain medications that affect liver enzymes or stomach acid within a specified time before starting the study treatment.
• Cannot swallow pills.
• Other specific criteria may apply as defined by the study protocol.