Brief Summary
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advancedat a late stage, far along or metastatic non squamous 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: Pembrolizumab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
Inclusion Criteria
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of advanced or metastatic non squamous NSCLC that is not eligible for curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence and/or definitive chemoradiotherapy
- Measurable disease, as defined by RECIST v1.1
- No prior systemic treatment for advanced or metastatic NSCLC
- Documentation of the presence of a KRAS G12C mutation
- Documentation of known PD-L1 expression status in tumor tissuea group of cells that work together to perform a function
- Availability of a representative tumor specimena sample for investigating (e.g. blood, stools, urine, sputum etc.)
- Adequate end-organ function
- Eligible to receive a platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells regimen