A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Hoffmann-La Roche
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, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Documentation of the presence of a KRAS G12C mutation * Documentation of known PD-L1 expression status in tumor tissue * Availability of a representative tumor specimen * Adequate end-organ function * Eligible to rec…
Interventions
- DrugDivarasib
Divarasib will be administered orally QD
- DrugPembrolizumab
Pembrolizumab will be administered via IV infusion Q3W
- DrugPemetrexed
Pemetrexed will be administered via IV infusion Q3W
- DrugCarboplatin
Carboplatin will be administered via IV infusion Q3W
- DrugCisplatin
Cisplatin will be administered via IV infusion Q3W
Locations (217)
- Alaska Oncology and HematologyAnchorage, Alaska
- City of Hope - PhoenixGoodyear, Arizona
- Marin Cancer Care IncGreenbrae, California
- Hoag Memorial HospitalNewport Beach, California
- Florida Cancer Specialists - SOUTH - SCRI - PPDSFort Myers, Florida
- BioResearch PartnerHialeah, Florida