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Phase 2Recruiting

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

Sponsored by Mirati Therapeutics Inc.

About this study

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score \<1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS \>=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and compa…

Where this study is enrolling (70)

  • USOR - Arizona Oncology - Prescott Valley

    Prescott Valley, Arizona

    Call 928-775-9430

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  • Arizona Clinical Research Center

    Tucson, Arizona

    Call 520-290-2510

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  • Highlands Oncology Group - Springdale

    Springdale, Arkansas

    Call 479-872-8130

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  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California

    Call 415-502-6959

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  • TRIO - Cancer & Blood Specialty Clinic - Los Alamitos

    Los Alamitos, California

    Call 562-706-6648

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Show all 70 locations

  • The Oncology Institute of Hope and Innovation - Corporate Office

    Cerritos, California

    Call 562-693-4477

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  • Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)

    Stockton, California

    Call 209-466-2626

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  • San Francisco Veterans Affairs Medical Center

    San Francisco, California

    Call 415-221-4810x23380

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  • Providence - Saint Joseph Home Health - Anaheim

    Anaheim, California

    Call 714-446-5900

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  • Providence Medical Group - Santa Rosa

    Santa Rosa, California

    Call 707-521-3830

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  • MemorialCare - Long Beach Medical Center

    Long Beach, California

    Call 562-997-4070

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  • USOR - Rocky Mountain Cancer Centers - Lone Tree

    Lone Tree, Colorado

    Call 303-430-2700

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  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut

    Call 860-886-8362

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  • USOR - Woodlands Medical Specialists

    Pensacola, Florida

    Call 850-696-4000

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  • Bay Pines Veterans Affairs Healthcare System

    Bay Pines, Florida

    Call 727-398-6661

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  • Cancer Specialists of North Florida - Southpoint

    Jacksonville, Florida

    Call 203-530-1728

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  • GenesisCare USA

    Aventura, Florida

    Call 239-938-9315

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  • SCRI - Florida Cancer Specialists - West Palm Beach

    West Palm Beach, Florida

    Call 407-933-2775

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  • James A. Haley Veterans Hospital

    Tampa, Florida

    Call 813-391-7763

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  • SCRI - Florida Cancer Specialists - Tallahassee Cancer Center

    Tallahassee, Florida

    Call 904-613-4275

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  • SCRI - Florida Cancer Specialists - South Region Research Office

    Fort Myers, Florida

    Call 239-274-9930

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  • AdventHealth Orlando

    Orlando, Florida

    Call 412-647-2811

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  • 21st Century Oncology of Jacksonville - North Lee Street

    Jacksonville, Florida

    Call 904-805-7061

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  • Miami Veterans Affairs Healthcare System

    Miami, Florida

    Call 305-575-7000

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  • Northwest Georgia Oncology Centers Wellstar - Marietta

    Marietta, Georgia

    I'm interested

  • University Cancer & Blood Center (UCBC) - Athens

    Athens, Georgia

    Call 706-353-2990

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  • Central Georgia Cancer Care - Macon

    Macon, Georgia

    Call 4787417145

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  • University of Chicago

    Chicago, Illinois

    I'm interested

  • USOR - Illinois Cancer Specialists - Niles

    Niles, Illinois

    Call 847-827-9060

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  • Advocate Medical Group Oncology

    Park Ridge, Illinois

    Call 000-000-0000

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  • Goshen Center for Cancer Care

    Goshen, Indiana

    Call 574-364-2848

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  • Cancer Center of Kansas - Wichita - Heritage Plaza

    Wichita, Kansas

    Call 316-262-4467

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  • MidAmerica Cancer Care - Research

    Merriam, Kansas

    Call 8162764700

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  • Lexington Medical Cancer Center Hematology/Oncology

    Lexington, Kentucky

    Call 859-260-6100

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  • Pontchartrain Cancer Center - Covington Office

    Covington, Louisiana

    Call 985-875-1202

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  • The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland

    Call 410-550-1711

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  • Dana-Farber Brigham and Womens Cancer Center at Milford Regional

    Milford, Massachusetts

    Call 7813379091

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 617-632-6036

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  • Dana-Farber Cancer Institute - Merrimack Valley

    Methuen, Massachusetts

    Call 9786202020

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  • Dana-Farber Brigham Cancer Center at South Shore Health

    South Weymouth, Massachusetts

    Call 7816244800

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  • Brigham and Womens/Mass General Health Care Center at Foxborough

    Foxborough, Massachusetts

    Call 7344536970

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  • Jackson Oncology Associates - The Hederman Cancer Center

    Jackson, Mississippi

    Call 601-355-2485

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  • Nebraska Cancer Specialists - Midwest Cancer Center - Legacy

    Omaha, Nebraska

    Call 531-329-3667

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  • OptumCare Nevada

    Las Vegas, Nevada

    Call 000-000-0000

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  • John Theurer Cancer Center

    Hackensack, New Jersey

    Call 954-267-7700

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  • Holy Name Medical Center

    Teaneck, New Jersey

    Call 201-227-6008

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  • Astera Cancer Care - East Brunswick

    East Brunswick, New Jersey

    Call 301-435-5332

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  • New York Oncology Hematology - Albany Medical Center

    Albany, New York

    Call 518-489-2607

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  • Montefiore Medical Center

    The Bronx, New York

    Call 718-405-8404

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  • Duke University Medical Center

    Durham, North Carolina

    Call 919-613-2000

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  • Kettering Health Cancer Center - Main Campus

    Kettering, Ohio

    Call 855-500-2873

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  • Tricounty Hematology and Oncology - Massillon

    Massillon, Ohio

    Call 3302686167

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  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio

    Call 216-286-6505

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  • USOR - Oncology Hematology Care - Blue Ash

    Cincinnati, Ohio

    Call 513-751-2273

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  • Mark H. Zangmeister Cancer Center

    Columbus, Ohio

    Call 502-561-7301

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  • USOR - Willamette Valley Cancer Institute and Research Center - Eugene

    Eugene, Oregon

    Call 541-683-5001

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  • Oregon Oncology Specialists

    Salem, Oregon

    Call 708-327-3180

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  • Veterans Affairs Pittsburgh Healthcare System - University Drive Campus

    Pittsburgh, Pennsylvania

    Call 4126237769

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  • Avera Cancer Institute

    Sioux Falls, South Dakota

    Call 605-322-6900

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  • Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

    Nashville, Tennessee

    Call 615-329-7274

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  • West Cancer Center & Research Institute - East Campus

    Germantown, Tennessee

    Call 901-683-0055

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  • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Odessa West Texas Cancer Center

    Odessa, Texas

    Call 000-000-0000

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  • USOR - Texas Oncology - Dallas Fort Worth (DFW) - South Austin

    Austin, Texas

    Call 512-427-9400

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  • USOR - Texas Oncology Northeast Texas - Denison

    Denison, Texas

    Call 000-000-0000

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  • USOR - Texas Oncology - San Antonio Medical Center

    Fredericksburg, Texas

    Call 210-595-5300

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  • USOR - Texas Oncology - The Woodlands

    The Woodlands, Texas

    Call 281-296-0365

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  • Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas

    Call 214-370-1000

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  • Virginia Cancer Institute - West End

    Richmond, Virginia

    Call 804-287-3000

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  • USOR - Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia

    Call 703-280-5390

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  • USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center

    Vancouver, Washington

    Call 503-885-5411

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Who can participate

Inclusion criteria

  • ✓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:
  • ✓1. No evidence of brain metastases
  • ✓2. Untreated brain metastases not needing immediate local therapy
  • ✓3. Previously treated brain metastases not needing immediate local therapy

Exclusion criteria

  • ✕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:
  • ✕1. Any untreated brain lesions \> 2.0 cm in size
  • ✕2. Any brainstem lesions
  • ✕3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
  • ✕4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
  • ✕Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

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.