Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

Prior treatment

• Previous treatment with a KRAS p.G12C inhibitor
• Subject has required a dose reduction or dose delay of either 5-fluorouracil (5-FU) or irinotecan in any prior chemotherapy regimen in the past for toxicity, to the investigator's knowledge

Other illness

• Leptomeningeal disease
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Other

• Active, untreated brain metastases

• Pathologically documented metastatic colorectal adenocarcinoma
• Central confirmation of KRAS p.G12C mutation
• Measurable disease per RECIST v1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation
• Age ≥ 18 years (or ≥ legal age within the country if it is more than 18 years)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
• Life expectancy of > 6 months, in the opinion of the investigator
• Adequate hematologic and end organ function
• Ability to take oral medications and willing to record daily adherence to investigational product
• Central laboratory detection of KRAS p.G12C mutation