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KRYSTAL-7: Adagrasib for Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

This study is testing Adagrasib, alone or with Pembrolizumab (Keytruda®), for advanced or metastatic non-small cell lung cancer (NSCLC). Adagrasib targets a specific gene change called KRAS G12C, which must be present in your cancer for you to join. Pembrolizumab is an immunotherapy that helps your immune system fight cancer. The study aims to see how well Adagrasib works and if combining it with Pembrolizumab is more effective than Pembrolizumab alone. Researchers will measure how long people live and if their tumors shrink. This trial is for adults aged 18 and older.

Study design
This study plans to enroll 626 participants and has two parts: a Phase 2 part testing Adagrasib alone or with Pembrolizumab, and a Phase 3 part comparing Adagrasib plus Pembrolizumab to Pembrolizumab alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The Phase 2 part will measure outcomes for 22 months, and the Phase 3 part will measure outcomes for 36 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.

NCT04613596

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mirati Therapeutics Inc.
~626 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AdagrasibPembrolizumab

At a glance

Recruiting sites
377 of 770 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Measured over 22 months
+1 more outcome measured

Conditions

Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer

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Where it's being run

770 sites across 136 states
Florida39
Germany33
Texas24
Spain24
Italy23
India22
Turkey (Türkiye)21
France19

Study leadership

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

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
Phase 3: Presence of measurable disease per RECIST1.1
Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:

Exclusion

Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
Phase 2: Active brain metastases
Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

What this trial measures

  • Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.22 months

    Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  • Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab36 months

    Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival