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Phase 2 Study of Adagrasib Combinations for Advanced NSCLC with KRAS G12C Mutation

This study is testing new combinations of medicines for advanced non-small cell lung cancer (NSCLC) that has a specific change in the KRAS gene called G12C. It's looking at whether adagrasib, given as a pill twice daily, works well when combined with pembrolizumab (an immunotherapy given by IV) and/or chemotherapy (pemetrexed and cisplatin/carboplatin, also given by IV). The study aims to see how many patients respond to the treatment (Objective Response Rate) and how long they live without their cancer growing (Progression-free Survival). You might be able to join if you have advanced NSCLC with the KRAS G12C mutation and specific levels of a biomarker called PD-L1. The study is currently unclear on its recruitment status and plans to enroll about 90 people.

Study design
This is a Phase 2, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll about 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes for up to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05609578

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Mirati Therapeutics Inc.
~90 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Adagrasib oral dose of 400 mg twice daily tabletsPembrolizumabChemotherapy: PemetrexedCisplatin/Carboplatin

At a glance

Recruiting sites
0 of 94 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) for Cohort A and E
Measured over 30 months
+1 more outcome measured

Conditions

Advanced NSCLC
Metastatic Lung Cancer

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Where it's being run

94 sites across 20 states
Colorado11
New York11
France10
Spain8
Kansas7
Italy7
Minnesota5
Texas5

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
Active brain metastases

What this trial measures

  • Objective Response Rate (ORR) for Cohort A and E30 months

    Defined as the percent of patients documented to have a confirmed CR or PR

  • Progression-free Survival (PFS) at six months for Cohort C30 months

    PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.