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Phase 3Recruiting

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)

Sponsored by Mirati Therapeutics Inc.

About this study

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

Where this study is enrolling (29)

  • Helios Clinical Research

    Long Beach, California

    Call 562-693-4477

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  • Providence Medical Foundation

    Fullerton, California

    Call 714-446-5900

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  • National Jewish Health Medical Center

    Denver, Colorado

    Call 303-388-4461

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  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware

    Call 302-366-1200

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  • Cancer Care Centers of Brevard, Inc.

    Palm Bay, Florida

    Call 111-111-1111

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Show all 29 locations

  • Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala

    Ocala, Florida

    Call 352-732-4938

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  • Florida Clinical Trials Group.

    Tamarac, Florida

    Call 561-447-0614

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  • Florida Clinical Trials Group.

    Plantation, Florida

    Call 561-447-0614

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  • Mid Florida Hematology and Oncology Center

    Orange City, Florida

    Call 407-353-1915

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  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida

    Call 813-745-6895

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  • Cancer Specialists of North Florida

    Jacksonville, Florida

    Call 904-538-4488

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  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia

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  • Illinois Cancer Specialists

    Arlington Heights, Illinois

    Call 847-827-9060

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  • Springfield Clinic Main Campus

    Springfield, Illinois

    Call 205-919-3812

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  • Parkview Research Center at Parkview Regional Medical Center

    Fort Wayne, Indiana

    Call 260-266-7100

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  • Northwest Cancer Centers, P.C.

    Dyer, Indiana

    Call 219-924-8178

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  • The University of Louisville, James Graham Brown Cancer Center

    Louisville, Kentucky

    Call 502-562-4358

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  • Saint Elizabeth Medical Center Edgewood

    Edgewood, Kentucky

    Call 859-301-4000

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  • Mercy Health-Paducah Medical Oncology and Hematology

    Paducah, Kentucky

    Call 000-000-0000

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  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana

    Call 318-813-3061

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  • Maryland Oncology Hematology - Columbia

    Columbia, Maryland

    Call 817-837-8660

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  • White Plains Hospital

    White Plains, New York

    Call 914-849-7600

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  • Ellis Hospital

    Schenectady, New York

    Call 517-331-4405

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  • WellSpan Oncology Research

    York, Pennsylvania

    Call 717-339-2560

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  • St Francis Cancer Center

    Greenville, South Carolina

    Call 864-603-6327

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  • SCRI Oncology Partners

    Nashville, Tennessee

    Call 615-320-5090

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  • Texas Oncology - San Antonio

    San Antonio, Texas

    Call 210-656-7177

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  • Texas Oncology - Northeast Texas

    Tyler, Texas

    Call 903-727-2200

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  • Texas Oncology Sammons Cancer Center

    Dallas, Texas

    Call 214-370-1000

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.