Brief Summary
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advancedat a late stage, far along or metastatic non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (NSCLC).
Intervention / Treatment
- Drug: Divarasib
- Drug: Sotorasib
- Drug: Adagrasib
Inclusion Criteria:
- Unequivocal histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of metastatic or locally advanced NSCLC not amenable to treatment with surgical resectionsurgical removal of tissue or part/all of an organ or combined chemoradiation
- Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Documentation of the presence of a KRAS G12C mutation
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathologythe study of disease report
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Life expectancy of >= 12 weeks