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Study of Adagrasib, Pembrolizumab, and Chemotherapy for KRAS G12C Non-Small Cell Lung Cancer

This study is for people with non-small cell lung cancer (NSCLC) that has a specific change called a KRAS G12C mutation and has not been treated before. It's testing a combination of three medicines: adagrasib, pembrolizumab, and chemotherapy (carboplatin and pemetrexed). Some participants will receive this combination, while others will receive pembrolizumab and chemotherapy along with a placebo (an inactive substance). The goal is to see if adding adagrasib helps people live longer without their cancer growing (progression-free survival) and improves overall survival. To join, your cancer must be locally advanced or have spread, and you need to have the KRAS G12C mutation. The study plans to enroll about 630 participants.

Study design
This is an interventional study comparing two treatment combinations in approximately 630 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 7 years to measure how long they live without their cancer growing and their overall survival.

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

NCT06875310

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Mirati Therapeutics Inc.
~630 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:AdagrasibPembrolizumabCarboplatinPemetrexedPlaceboCisplatin

At a glance

Recruiting sites
282 of 351 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Measured over Up to 7 years
+1 more outcome measured

Conditions

Carcinoma, Non-Small-Cell Lung

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Where it's being run

351 sites across 198 states
Florida11
Japan8
France7
Turkey (Türkiye)7
Germany6
Romania6
Texas5
Guangdong5

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

Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
Locally advanced or metastatic disease.
Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
No prior systemic anti-cancer therapy given for advanced or metastatic disease.
Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.

Exclusion

Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.

What this trial measures

  • Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)Up to 7 years
  • Overall Survival (OS)Up to 7 years