NCT06793215

A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Cancer
• KRAS G12C Lung Cancer

Interventions

Type	Name	Description
DRUG	Divarasib	Divarasib will be administered orally QD
DRUG	Pembrolizumab	Pembrolizumab will be administered via IV infusion Q3W
DRUG	Pemetrexed	Pemetrexed will be administered via IV infusion Q3W
DRUG	Carboplatin	Carboplatin will be administered via IV infusion Q3W
DRUG	Cisplatin	Cisplatin will be administered via IV infusion Q3W

Timeline

• Start date: 2025-10-24
• Primary completion: 2028-11-30
• Completion: 2030-10-31
• First posted: 2025-01-27
• Last updated: 2026-04-13

Locations

217 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study