Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, 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: Pembrolizumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Pemetrexed
Inclusion Criteria:
- Confirmation of Biomarker eligibility
- Pre-treatment tumor tissuea group of cells that work together to perform a function along with an associated pathologythe study of disease report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) of 0 or 1
- Histologically or cytologically documented locally advanced unresectable or metastatic 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
- No prior systemic treatment for advanced unresectable or metastatic NSCLC
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1