About this trial
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, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
Measurable disease, as defined by RECIST v1.1
No prior systemic treatment for advanced or metastatic NSCLC
Disqualifiers
Known concomitant second oncogenic driver with available targeted treatment
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
History of leptomeningeal disease
Trial design
Treatments tested in this trial
- Divarasib
- Pembrolizumab
- Pemetrexed
- Carboplatin
- Cisplatin
Treatment groups
Locations
251Sponsors and collaborators
Hoffmann-La Roche
Lead sponsor
Chugai Pharmaceutical
Collaborator