A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
NCT06875310 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630
Last updated 2026-05-13
Summary
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
Specified dose on specified days
- DRUG
-
Adagrasib
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Pemetrexed
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Mirati Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-24
- Primary Completion
- 2029-09-07
- Completion
- 2032-04-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Croatia
- France
- Germany
- Greece
- Hong Kong
- Hungary
- India
- Ireland
- Israel
- Italy
- Japan
- Mexico
- Netherlands
- Poland
- Portugal
- Romania
- Saudi Arabia
- South Korea
- Spain
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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