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

No results posted yet for this study

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

Cisplatin

Specified dose on specified days

DRUG

Adagrasib

Specified dose on specified days

DRUG

Pembrolizumab

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Placebo

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06875310 on ClinicalTrials.gov