A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

Inclusion Criteria

• Adult (= or > 18 years old) with NSCLC
• Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
• Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
• Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• No active brain metastases
• Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria

• Mixed small-cell lung cancer and NSCLC histology
• Myocardial Infarction within 6 months of study Day 1
• Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
• Therapeutic or palliative radiation therapy within 2 weeks of study day 1
• Unable to take oral medication
• Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans