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Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

NCT04613596 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2026-05-20

No results posted yet for this study

Summary

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.

The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Conditions

Interventions

DRUG

Adagrasib

Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

DRUG

Adagrasib

Adagrasib 600 mg BID monotherapy (Cohort 1b)

DRUG

Adagrasib

adagrasib 400 mg BID in combination with pembrolizumab

DRUG

Adagrasib

Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV Q3W

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2032-06-09
Completion
2032-06-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04613596 on ClinicalTrials.gov