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Clinical Trials in the USA / NCT06875310
Recruiting Phase 3

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)

NCT06875310 · tracked via the Priya Life Science USA tracker
Sponsor
Mirati Therapeutics Inc.
Phase
Phase 3
Started
2025-04-24
Last updated
2026-09-01

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

AdagrasibPembrolizumabCarboplatinPemetrexedPlaceboCisplatin

Adagrasib: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Carboplatin: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Placebo: Specified dose on specified days

Cisplatin: Specified dose on specified days

Study summary

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (351)

FacilityCityRegionStatus
Local Institution - 0347 Birmingham Alabama Not Yet Recruiting
Local Institution - 0686 Springdale Arkansas Not Yet Recruiting
Providence Medical Foundation Fullerton California Recruiting
Local Institution - 0682 Loma Linda California Not Yet Recruiting
Helios Clinical Research Long Beach California Recruiting
National Jewish Health Medical Center Denver Colorado Recruiting
Medical Oncology Hematology Consultants, PA Newark Delaware Recruiting
Local Institution - 0694 Clearwater Florida Not Yet Recruiting
Cancer Specialists of North Florida Jacksonville Florida Recruiting
Local Institution - 0696 Miami Florida Not Yet Recruiting
Local Institution - 0680 Ocala Florida Not Yet Recruiting
Mid Florida Hematology and Oncology Center Orange City Florida Recruiting
Cancer Care Centers of Brevard, Inc. Palm Bay Florida Recruiting
Florida Clinical Trials Group. Plantation Florida Recruiting
Local Institution - 0695 St. Petersburg Florida Not Yet Recruiting
Florida Clinical Trials Group. Tamarac Florida Recruiting
Local Institution - 0647 Tampa Florida Not Yet Recruiting
Local Institution - 0699 Tampa Florida Not Yet Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
Local Institution - 0676 Chicago Illinois Not Yet Recruiting
Springfield Clinic Main Campus Springfield Illinois Recruiting
Northwest Cancer Centers, P.C. Dyer Indiana Recruiting
Parkview Research Center at Parkview Regional Medical Center Fort Wayne Indiana Recruiting
Local Institution - 0423 Munster Indiana Withdrawn
Mercy Medical Center Cedar Rapids Iowa Recruiting
Saint Elizabeth Medical Center Edgewood Edgewood Kentucky Recruiting
Local Institution - 0566 Louisville Kentucky Not Yet Recruiting
Owensboro Medical Health System Owensboro Kentucky Recruiting
Mercy Health-Paducah Medical Oncology and Hematology Paducah Kentucky Recruiting
Louisiana State University Health Sciences Shreveport Shreveport Louisiana Recruiting
Local Institution - 0702 Annapolis Maryland Not Yet Recruiting
Maryland Oncology Hematology - Columbia Columbia Maryland Recruiting
Local Institution - 0019 Boston Massachusetts Not Yet Recruiting
Local Institution - 0293 Detroit Michigan Not Yet Recruiting
Local Institution - 0685 Fenton Missouri Not Yet Recruiting
Local Institution - 0678 Cooperstown New York Not Yet Recruiting
Ellis Hospital Schenectady New York Recruiting
White Plains Hospital White Plains New York Recruiting
Local Institution - 0624 Asheville North Carolina Not Yet Recruiting

+ 311 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Mirati Therapeutics Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875310 on ClinicalTrials.gov ↗ ← All trials in the USA