Recruiting
Phase 2
Phase 3

Adagrasib & Pembrolizumab

Sponsor:

Mirati Therapeutics Inc.

Code:

NCT04613596

Conditions

Advanced Non-Small Cell Lung Cancer

Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adagrasib

Adagrasib

Adagrasib

Adagrasib

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Advanced Non-Small Cell Lung Cancer

Metastatic Non-Small Cell Lung Cancer

Study ID

NCT04613596

Start date

Dec 2, 2020

Status verified date

Aug, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

626 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%

Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab

experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%

Cohort 1b: Adagrasib BID monotherapy

experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%

Cohort 2: Adagrasib BID in combination with pembrolizumab

experimental: Phase 3 Cohort 3 Investigational Arm

Adagrasib BID in combination with pembrolizumab

active comparator: Phase 3 Cohort 4 Comparator Arm

Pembrolizumab

Interventions

Adagrasib

Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

Adagrasib

Adagrasib 600 mg BID monotherapy (Cohort 1b)

Adagrasib

adagrasib 400 mg BID in combination with pembrolizumab

Adagrasib

Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

Pembrolizumab

Pembrolizumab 200 mg IV Q3W

Primary outcome measure

  • Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC. [ Time Frame: 22 months ]
  • Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

USOR - Arizona Oncology - Prescott Valley

Recruiting

Prescott Valley, Arizona, United States, 86301

Contacts

Allan Espinosa Morazan, Site 007-556

928-775-9430

Arizona Clinical Research Center

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Manuel Modiano, Site 007-568

520-290-2510

Highlands Oncology Group - Springdale

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Eric Schaefer, Site 007-978

479-872-8130

Providence - Saint Joseph Home Health - Anaheim

Recruiting

Anaheim, California, United States, 92805

Contacts

Giribala Patel, Site 007-899

714-446-5900

The Oncology Institute of Hope and Innovation - Corporate Office

Recruiting

Cerritos, California, United States, 90703

Contacts

Omkar Marathe, Site 007-898

562-693-4477

MemorialCare - Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Nilesh Vora, Site 007-936

562-997-4070

TRIO - Cancer & Blood Specialty Clinic - Los Alamitos

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Nihal Abdulla, Site 007-779

562-706-6648

San Francisco Veterans Affairs Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Sunny Wang, Site 007-581

415-221-4810x23380

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Collin Blakely, Site 007-540

415-502-6959

Providence Medical Group - Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Manasa Vulchi, Site 007-858

707-521-3830

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

Recruiting

Stockton, California, United States, 95219

Contacts

Sunny K. Philip, Jr., Site 007-582

209-466-2626

USOR - Rocky Mountain Cancer Centers - Lone Tree

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Robert Jotte, Site 007-872

303-430-2700

Eastern Connecticut Hematology and Oncology Associates

Recruiting

Norwich, Connecticut, United States, 06360

Contacts

Dennis Slater, Site 007-949

860-886-8362

GenesisCare USA

Recruiting

Aventura, Florida, United States, 33180

Contacts

Edgardo Santos, Site 007-552

239-938-9315

Bay Pines Veterans Affairs Healthcare System

Recruiting

Bay Pines, Florida, United States, 33744

Contacts

Ryan Burri, Site 007-593

727-398-6661

SCRI - Florida Cancer Specialists - South Region Research Office

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Fadi Kayali, Site 007-922

239-274-9930

21st Century Oncology of Jacksonville - North Lee Street

Recruiting

Jacksonville, Florida, United States, 32204

Contacts

Troy Guthrie, Site 007-853

904-805-7061

Cancer Specialists of North Florida - Southpoint

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Gaurav Trikha, Site 007-562

203-530-1728

Miami Veterans Affairs Healthcare System

Recruiting

Miami, Florida, United States, 33125-1624

Contacts

Gregory Holt, Site 007-594

305-575-7000

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Mark Socinski, Site 007-896

412-647-2811

USOR - Woodlands Medical Specialists

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Michael Poiesz, Site 007-877

850-696-4000

SCRI - Florida Cancer Specialists - Tallahassee Cancer Center

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Augusto Villegas, Site 007-924

904-613-4275

James A. Haley Veterans Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

John Accomando, Site 007-937

813-391-7763

SCRI - Florida Cancer Specialists - West Palm Beach

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Barry Berman, Site 007-926

407-933-2775

University Cancer & Blood Center (UCBC) - Athens

Recruiting

Athens, Georgia, United States, 30607

Contacts

Gustavo Westin, Site 007-941

706-353-2990

Central Georgia Cancer Care - Macon

Recruiting

Macon, Georgia, United States, 31201

Contacts

Bradley Sumrall, Site 007-5478

4787417145

Northwest Georgia Oncology Centers Wellstar - Marietta

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Steven McCune, Site 007-786

770-281-5162

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

USOR - Illinois Cancer Specialists - Niles

Recruiting

Niles, Illinois, United States, 60714

Contacts

David Hakimian, Site 007-883

847-827-9060

Advocate Medical Group Oncology

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Jason Macklis, Site 007-567

000-000-0000

Goshen Center for Cancer Care

Recruiting

Goshen, Indiana, United States, 46526

Contacts

Ebenezer Kio, Site 007-943

574-364-2848

MidAmerica Cancer Care - Research

Recruiting

Merriam, Kansas, United States, 66204

Contacts

Jaswinder Singh, Site 007-5484

8162764700

Cancer Center of Kansas - Wichita - Heritage Plaza

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Shaker Dakhil, Site 007-942

316-262-4467

Lexington Medical Cancer Center Hematology/Oncology

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Firas Badin, Site 007-965

859-260-6100

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Pontchartrain Cancer Center - Covington Office

Recruiting

Covington, Louisiana, United States, 70433

Contacts

David Oubre, Site 007-994

985-875-1202

The Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Kristen Marrone, Site 007-944

410-550-1711

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Pasi Janne, Site 007-808

617-632-6036

Dana-Farber Cancer Institute at St. Elizabeths Medical Center

Recruiting

Brighton, Massachusetts, United States, 02135

Brigham and Womens/Mass General Health Care Center at Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Naeem Tahir, Site 007-5480

7344536970

Dana-Farber Cancer Institute - Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Contacts

Pedro Sanz-Altamira, Site 007-5482

9786202020

Dana-Farber Brigham and Womens Cancer Center at Milford Regional

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Alexandra Bailey, Site 007-5479

7813379091

Dana-Farber Brigham Cancer Center at South Shore Health

Recruiting

South Weymouth, Massachusetts, United States, 02190

Contacts

Randi Carhart, Site 007-5481

7816244800

USOR - Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Jackson Oncology Associates - The Hederman Cancer Center

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Natale Sheehan, Site 007-588

601-355-2485

Nebraska Cancer Specialists - Midwest Cancer Center - Legacy

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Mary Wells, Site 007-590

531-329-3667

OptumCare Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Russell Gollard, Site 007-938

000-000-0000

Astera Cancer Care - East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Bruno Fang, Site 007-975

301-435-5332

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Martin Gutierrez, Site 007-854

954-267-7700

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Yadyra Rivera, Site 007-784

201-227-6008

New York Oncology Hematology - Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Makenzi Evangelist, Site 007-861

518-489-2607

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Balazs Halmos, Site 007-945

718-405-8404

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Thomas Stinchcombe, Site 007-946

919-613-2000

USOR - Oncology Hematology Care - Blue Ash

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Patrick Ward, Site 007-893

513-751-2273

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Melinda Hsu, Site 007-849

216-286-6505

Mark H. Zangmeister Cancer Center

Recruiting

Columbus, Ohio, United States, 43219

Contacts

Jorge Rios-perez, Site 007-930

502-561-7301

Kettering Health Cancer Center - Main Campus

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Alejandro Calvo, Site 007-836

855-500-2873

Tricounty Hematology and Oncology - Massillon

Recruiting

Massillon, Ohio, United States, 44646

Contacts

Noman Rafique, Site 007-5486

3302686167

USOR - Willamette Valley Cancer Institute and Research Center - Eugene

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Bo Wang, Site 007-889

541-683-5001

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

Contacts

Janelle Meyer, Site 007-967

708-327-3180

Veterans Affairs Pittsburgh Healthcare System - University Drive Campus

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

James Herman, Site 007-5477

4126237769

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Benjamin Solomon, Site 007-940

605-322-6900

West Cancer Center & Research Institute - East Campus

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Ramakrishna Battini, Site 007-916

901-683-0055

Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Johnson, Site 007-928

615-329-7274

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

Recruiting

Austin, Texas, United States, 78745

Contacts

James Uyeki, Site 007-892

512-427-9400

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

Recruiting

Dallas, Texas, United States, 75246

Contacts

Kartik Konduri, Site 007-879

214-370-1000

USOR - Texas Oncology Northeast Texas - Denison

Recruiting

Denison, Texas, United States, 75020

Contacts

Amir Faridi, Site 007-890

000-000-0000

USOR - Texas Oncology - San Antonio Medical Center

Recruiting

Fredericksburg, Texas, United States, 78624

Contacts

Angel Mier-Hicks, Site 007-927

210-595-5300

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

Recruiting

Odessa, Texas, United States, 79761

Contacts

Pankaj Khandelwal, Site 007-554

000-000-0000

USOR - Texas Oncology - The Woodlands

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Kruti Sheth Nair, Site 007-894

281-298-8907

USOR - Virginia Cancer Specialists - Fairfax Office

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Alexander Spira, Site 007-814

703-280-5390

Virginia Cancer Institute - West End

Recruiting

Richmond, Virginia, United States, 23229

Contacts

Thomas Weart, Site 007-539

804-287-3000

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

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Anthony Van Ho, Site 007-885

503-885-5411

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Quincy Chu, Site 007-488

7804328248

British Columbia Cancer Agency - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Janessa Laskin, Site 007-480

111-111-1111

Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Nicholas Garth, Site 007-481

6137377700

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Penelope Bradbury, Site 007-482

4169463544

More Information

Sponsor

Mirati Therapeutics Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • KRAS G12C
  • Non-small cell lung cancer
  • NSCLC
  • Metastatic Non-Small Cell Lung Cancer
  • Adagrasib
  • Krazati
  • TPS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mirati Therapeutics Inc. on 2026-08-25.