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Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

NCT05609578 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-17

No results posted yet for this study

Summary

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation

Conditions

  • Advanced NSCLC
  • Metastatic Lung Cancer

Interventions

DRUG

Adagrasib oral dose of 400 mg twice daily tablets

oral dose of 400 mg twice daily tablets

COMBINATION_PRODUCT

Pembrolizumab

IV infusion once every 3 weeks

COMBINATION_PRODUCT

Chemotherapy: Pemetrexed

IV infusion once every 3 weeks

COMBINATION_PRODUCT

Cisplatin/Carboplatin

IV infusion once every 3 weeks

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-06-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • France
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Malaysia
  • Poland
  • Serbia
  • Spain
  • Switzerland
  • Thailand

Study Locations

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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 NCT05609578 on ClinicalTrials.gov