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
NCT06793215 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2026-05-11
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
- DRUG
-
Divarasib
Divarasib will be administered orally QD
- DRUG
-
Pembrolizumab will be administered via IV infusion Q3W
- DRUG
-
Pemetrexed
Pemetrexed will be administered via IV infusion Q3W
- DRUG
-
Carboplatin will be administered via IV infusion Q3W
- DRUG
-
Cisplatin will be administered via IV infusion Q3W
Sponsors & Collaborators
-
Chugai Pharmaceutical
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-24
- Primary Completion
- 2028-11-30
- Completion
- 2030-10-31
- FDA Drug
- Yes
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
Study Locations
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