RecruitingPhase 2NCT05609578

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Sponsor

Mirati Therapeutics Inc.

Enrollment

90 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Lung Cancer Advanced NSCLC

Summary

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combinations of a targeted drug called adagrasib for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C. Different cohorts are testing adagrasib with immunotherapy, chemotherapy, or other combinations depending on your prior treatment history. **You may be eligible if...** - You have confirmed KRAS G12C-mutated advanced or metastatic NSCLC - Depending on the cohort: you may be untreated with specific PD-L1 expression levels, OR have completed 4 cycles of first-line chemotherapy plus immunotherapy (pembrolizumab) - Your tumor must be non-squamous (for some cohorts) or squamous (for others) **You may NOT be eligible if...** - Your tumor does not carry the KRAS G12C mutation - You do not meet the PD-L1 expression threshold for the relevant cohort - You have not yet completed the required prior treatment (for certain cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdagrasib oral dose of 400 mg twice daily tablets

oral dose of 400 mg twice daily tablets

COMBINATION_PRODUCTPembrolizumab

IV infusion once every 3 weeks

COMBINATION_PRODUCTChemotherapy: Pemetrexed

IV infusion once every 3 weeks

COMBINATION_PRODUCTCisplatin/Carboplatin

IV infusion once every 3 weeks

Locations(166)

Local Institution - Unk025

Anchorage, Alaska, United States

Local Institution - 017-591

Glendale, Arizona, United States

Local Institution - 017-821

Phoenix, Arizona, United States

Local Institution - Unk047

Anaheim, California, United States

Local Institution - 017-936C

Fountain Valley, California, United States

MemorialCare - Orange Coast Medical Center

Fountain Valley, California, United States

Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton

Fullerton, California, United States

Local Institution - Unk004

Loma Linda, California, United States

Local Institution - 017-961

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Local Institution - 017-872-I

Aurora, Colorado, United States

Local Institution - 017-872-G

Boulder, Colorado, United States

Local Institution - 017-872-D

Colorado Springs, Colorado, United States

Local Institution - 017-872-J

Colorado Springs, Colorado, United States

Local Institution - 017-872-B

Denver, Colorado, United States

Local Institution - 017-872-F

Denver, Colorado, United States

Local Institution - 017-872-A

Lakewood, Colorado, United States

Local Institution - 017-872-C

Littleton, Colorado, United States

USOR - Rocky Mountain Cancer Centers - Lone Tree - Sky Ridge Medical Center

Lone Tree, Colorado, United States

Local Institution - 017-872-E

Pueblo, Colorado, United States

Local Institution - 017-872-H

Thornton, Colorado, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

The Oncology Institute of Hope and Innovation - Lakeland

Lakeland, Florida, United States

Local Institution - Unk076

Miami, Florida, United States

Local Institution - Unk055

Orlando, Florida, United States

Local Institution - Unk062

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Local Institution - 017-820J

Fairway, Kansas, United States

Local Institution - 017-820A

Kansas City, Kansas, United States

Local Institution - 017-820B

Kansas City, Kansas, United States

Local Institution - 017-820C

Kansas City, Kansas, United States

Local Institution - 017-820H

Kansas City, Kansas, United States

Local Institution - 017-820I

Overland Park, Kansas, United States

University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion

Westwood, Kansas, United States

Local Institution - 017-965

Lexington, Kentucky, United States

Local Institution - Unk009

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Local Institution - Unk039

Burlington, Massachusetts, United States

Local Institution - Unk069

Detroit, Michigan, United States

Local Institution - Unk018

Lansing, Michigan, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Local Institution - 017-838B

Minneapolis, Minnesota, United States

Local Institution - 017-838C

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

Saint Louis Park, Minnesota, United States

Local Institution - 017-838A

Saint Louis Park, Minnesota, United States

Local Institution - 017-820F

Kansas City, Missouri, United States

Local Institution - 017-820E

Kansas City, Missouri, United States

Local Institution - 017-820D

Lee's Summit, Missouri, United States

Local Institution - 017-820G

North Kansas City, Missouri, United States

Local Institution - Unk008

Osage Beach, Missouri, United States

Local Institution - Unk058

Springfield, Missouri, United States

Local Institution - 017-080

Babylon, New York, United States

Local Institution - 017-088

Brooklyn, New York, United States

Hematology-Oncology Associates of Central New York - Brittonfield - East Syracuse

East Syracuse, New York, United States

Local Institution - 017-087

New Hyde Park, New York, United States

Local Institution - 017-085

New York, New York, United States

Local Institution - 017-082

Patchogue, New York, United States

Local Institution - 017-086

Port Jefferson, New York, United States

Local Institution - 017-081

Port Jefferson Station, New York, United States

New York Cancer & Blood Specialists - Cancer Center - Research Headquarters

Port Jefferson Station, New York, United States

Local Institution - 017-084

Riverhead, New York, United States

Local Institution - 017-945

The Bronx, New York, United States

Local Institution - 017-083

The Bronx, New York, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Local Institution - 017-836

Kettering, Ohio, United States

Local Institution - 017-916

Memphis, Tennessee, United States

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

Dallas, Texas, United States

Local Institution - Unk056

Dallas, Texas, United States

Local Institution - 017-848

Houston, Texas, United States

Local Institution - 017-999

Irving, Texas, United States

USOR - Texas Oncology Northeast Texas - Longview Cancer Center

Longview, Texas, United States

Local Institution - 017-878-B

Palestine, Texas, United States

Local Institution - 017-878-C

Paris, Texas, United States

Local Institution - 017-878-A

Tyler, Texas, United States

Local Institution - Unk010

Salt Lake City, Utah, United States

Local Institution - 017-814-A

Arlington, Virginia, United States

Local Institution - Unk066

Fairfax, Virginia, United States

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States

Local Institution - 017-814-B

Gainesville, Virginia, United States

Local Institution - 017-814-C

Reston, Virginia, United States

PeaceHealth St. Joseph Medical Center

Bellingham, Washington, United States

Local Institution - Unk036

Huntington, West Virginia, United States

Local Institution - 017-458

Natal, Rio Grande do Norte, Brazil

Local Institution - 017-446

Ijuí, Rio Grande do Sul, Brazil

Local Institution - 017-453

Itajaí, Santa Catarina, Brazil

Local Institution - 017-457

Barretos, Brazil

Local Institution - 017-442

Curitiba, Brazil

Local Institution - 017-452

Fortaleza, Brazil

Local Institution - 017-455

Jaú, Brazil

Local Institution - 017-454

Rio de Janeiro, Brazil

Local Institution - 017-456

São Paulo, Brazil

Local Institution - 017-695

Viña del Mar, Valparaiso, Chile

Local Institution - 017-697

Providencia, Chile

Local Institution - 017-696

Santiago, Chile

Local Institution - 017-698

Temuco, Chile

Institut de Cancerologie de lOuest - Angers

Angers, France

Centre Francois Baclesse

Caen, France

Centre Hospitalier Intercommunal de Creteil

Créteil, France

Centre Georges Francois Leclerc

Dijon, France

Hopital Michallon

La Tronche, France

Local Institution - 017-688

Lille, France

Local Institution - Unk078

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Local Institution - Unk067

Marseille, France

Local Institution - 017-200

Montpellier, France

Local Institution - Unk029

Paris, France

Hopital Tenon

Paris, France

Local Institution - 017-664

Paris, France

Local Institution - 017-198

Saint-Herblain, France

Hopital Foch

Suresnes, France

Hopital Larrey

Toulouse, France

Gustave Roussy

Villejuif, France

Local Institution - 017-790

Batumi, Georgia

Local Institution - 017-789

Tbilisi, Georgia

Local Institution - 017-794

Tbilisi, Georgia

Local Institution - 017-791

Tbilisi, Georgia

Local Institution - 017-792

Tbilisi, Georgia

Local Institution - 017-793

Tbilisi, Georgia

University General Hospital of Heraklion (PAGNI)

Heraklion, Greece

University General Hospital of Larissa

Larissa, Greece

Metropolitan Hospital

Piraeus, Greece

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, Hungary

Local Institution - 017-767 - B

Faenza, Ravenna, Italy

Local Institution - 017-767 - A

Lugo, Ravenna, Italy

Azienda Ospedaliera San Giuseppe Moscati - Avellino

Avellino, Italy

Local Institution - 017-274

Aviano, Italy

Ospedale Santo Spirito

Casale Monferrato, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Italy

Local Institution - 017-297

Padova, Italy

Ospedale Santa Maria delle Croci di Ravenna

Ravenna, Italy

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Italy

Local Institution - 017-280

Roma, Italy

Local Institution - 017-076

Kota Bharu, Kelantan, Malaysia

Local Institution - 017-075

Kuantan, Pahang, Malaysia

Local Institution - 017-073

Kuala Lumpur, Malaysia

Local Institution - 017-072

Putrajaya, Malaysia

Local Institution - 017-381

Konin, Poland

Instytut MSF

Lodz, Poland

Med Polonia Sp. z o. o. - Obornicka

Poznan, Poland

Wojskowy Instytut Medyczny

Warsaw, Poland

Local Institution - 017-692

Belgrade, Serbia

Local Institution - 017-693

Belgrade, Serbia

Local Institution - 017-690

Belgrade, Serbia

Local Institution - 017-691

Kamenitz, Serbia

Local Institution - 017-694

Kragujevac, Serbia

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Spain

Local Institution - Unk001

Málaga, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Hospital Son Llatzer

Palma de Mallorca, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Local Institution - 017-395

Geneva, Switzerland

Local Institution - 017-132

Bang Phlat, Thailand

Local Institution - 017-136

Bangkok, Thailand

Local Institution - 017-135

Chom Thong, Thailand

Local Institution - 017-137

Khon Kaen, Thailand

View Full Details on ClinicalTrials.gov

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NCT05609578

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