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

NCT05609578 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CA239-0010849-017
• Study Type: interventional
• Target: 90
• Locations: 14 countries
• Sites: 166

Brief 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

Conditions

Advanced NSCLC; Metastatic Lung Cancer

Keywords

KRAS G12C; NSCLC; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) for Cohort A and E

  Defined as the percent of patients documented to have a confirmed CR or PR

  30 months

• Progression-free Survival (PFS) at six months for Cohort C

  PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

  30 months

Secondary Outcomes (6)

• Adverse Events

  30 months

• Duration of Response (DOR)

  30 months

• Overall Survival (OS)

  30 months

• Progression-free Survival (PFS)

  30 months

• Population pharmacokinetic (PK) Model Derived AUC at Steady State (AUCtau,ss).

  Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months

Study Arms (3)

Cohort A: PD-L1 TPS≥ 1% (Closed)

EXPERIMENTAL

Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles

Drug: Adagrasib oral dose of 400 mg twice daily tablets

Cohort C

EXPERIMENTAL

Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles

Drug: Adagrasib oral dose of 400 mg twice daily tablets; Combination Product: Pembrolizumab; Combination Product: Chemotherapy: Pemetrexed; Combination Product: Cisplatin/Carboplatin

Cohort E

EXPERIMENTAL

Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)

Drug: Adagrasib oral dose of 400 mg twice daily tablets; Combination Product: Pembrolizumab; Combination Product: Chemotherapy: Pemetrexed; Combination Product: Cisplatin/Carboplatin

Interventions

Adagrasib oral dose of 400 mg twice daily tablets DRUG

oral dose of 400 mg twice daily tablets

Cohort A: PD-L1 TPS≥ 1% (Closed); Cohort C; Cohort E

Pembrolizumab COMBINATION_PRODUCT

IV infusion once every 3 weeks

Cohort C; Cohort E

Chemotherapy: Pemetrexed COMBINATION_PRODUCT

IV infusion once every 3 weeks

Cohort C; Cohort E

Cisplatin/Carboplatin COMBINATION_PRODUCT

IV infusion once every 3 weeks

Cohort C; Cohort E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
• Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
• Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
• Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
• Active brain metastases

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (166)

Local Institution - Unk025

Anchorage, Alaska, 99508, United States

ACTIVE NOT RECRUITING

Local Institution - 017-591

Glendale, Arizona, 85304, United States

WITHDRAWN

Local Institution - 017-821

Phoenix, Arizona, 85004, United States

WITHDRAWN

Local Institution - Unk047

Anaheim, California, 92805, United States

ACTIVE NOT RECRUITING

Local Institution - 017-936C

Fountain Valley, California, 92708, United States

NOT YET RECRUITING

MemorialCare - Orange Coast Medical Center

Fountain Valley, California, 92708, United States

RECRUITING

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

Fullerton, California, 92835, United States

RECRUITING

Local Institution - Unk004

Loma Linda, California, 92354, United States

ACTIVE NOT RECRUITING

Local Institution - 017-961

Los Angeles, California, 90095, United States

WITHDRAWN

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

RECRUITING

Local Institution - 017-872-I

Aurora, Colorado, 80012, United States

NOT YET RECRUITING

Local Institution - 017-872-G

Boulder, Colorado, 80303, United States

NOT YET RECRUITING

Local Institution - 017-872-D

Colorado Springs, Colorado, 80907, United States

NOT YET RECRUITING

Local Institution - 017-872-J

Colorado Springs, Colorado, 80920, United States

NOT YET RECRUITING

Local Institution - 017-872-B

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Local Institution - 017-872-F

Denver, Colorado, 80220, United States

NOT YET RECRUITING

Local Institution - 017-872-A

Lakewood, Colorado, 80228, United States

NOT YET RECRUITING

Local Institution - 017-872-C

Littleton, Colorado, 80218, United States

NOT YET RECRUITING

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

Lone Tree, Colorado, 80124, United States

RECRUITING

Local Institution - 017-872-E

Pueblo, Colorado, 81003, United States

NOT YET RECRUITING

Local Institution - 017-872-H

Thornton, Colorado, 80260, United States

NOT YET RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

The Oncology Institute of Hope and Innovation - Lakeland

Lakeland, Florida, 33812, United States

RECRUITING

Local Institution - Unk076

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

Local Institution - Unk055

Orlando, Florida, 32803, United States

ACTIVE NOT RECRUITING

Local Institution - Unk062

Chicago, Illinois, 60612, United States

ACTIVE NOT RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Local Institution - 017-820J

Fairway, Kansas, 66205, United States

NOT YET RECRUITING

Local Institution - 017-820A

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Local Institution - 017-820B

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Local Institution - 017-820C

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Local Institution - 017-820H

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Local Institution - 017-820I

Overland Park, Kansas, 66210, United States

NOT YET RECRUITING

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

Westwood, Kansas, 66205, United States

RECRUITING

Local Institution - 017-965

Lexington, Kentucky, 40503, United States

WITHDRAWN

Local Institution - Unk009

Baltimore, Maryland, 21201, United States

ACTIVE NOT RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Local Institution - Unk039

Burlington, Massachusetts, 01803, United States

ACTIVE NOT RECRUITING

Local Institution - Unk069

Detroit, Michigan, 48201, United States

ACTIVE NOT RECRUITING

Local Institution - Unk018

Lansing, Michigan, 488912, United States

ACTIVE NOT RECRUITING

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

RECRUITING

Local Institution - 017-838B

Minneapolis, Minnesota, 55404, United States

NOT YET RECRUITING

Local Institution - 017-838C

Minneapolis, Minnesota, 55404, United States

NOT YET RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Local Institution - 017-838A

Saint Louis Park, Minnesota, 55426-5000, United States

NOT YET RECRUITING

Local Institution - 017-820F

Kansas City, Missouri, 64116, United States

NOT YET RECRUITING

Local Institution - 017-820E

Kansas City, Missouri, 64154, United States

NOT YET RECRUITING

Local Institution - 017-820D

Lee's Summit, Missouri, 64064, United States

NOT YET RECRUITING

Local Institution - 017-820G

North Kansas City, Missouri, 64116, United States

NOT YET RECRUITING

Local Institution - Unk008

Osage Beach, Missouri, 65065, United States

ACTIVE NOT RECRUITING

Local Institution - Unk058

Springfield, Missouri, 65807, United States

ACTIVE NOT RECRUITING

Local Institution - 017-080

Babylon, New York, 11702, United States

NOT YET RECRUITING

Local Institution - 017-088

Brooklyn, New York, 11210, United States

NOT YET RECRUITING

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

East Syracuse, New York, 13057, United States

RECRUITING

Local Institution - 017-087

New Hyde Park, New York, 11042, United States

NOT YET RECRUITING

Local Institution - 017-085

New York, New York, 10028, United States

NOT YET RECRUITING

Local Institution - 017-082

Patchogue, New York, 11772, United States

NOT YET RECRUITING

Local Institution - 017-086

Port Jefferson, New York, 11776, United States

NOT YET RECRUITING

Local Institution - 017-081

Port Jefferson Station, New York, 11776, United States

NOT YET RECRUITING

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

Port Jefferson Station, New York, 11776, United States

RECRUITING

Local Institution - 017-084

Riverhead, New York, 11901, United States

NOT YET RECRUITING

Local Institution - 017-945

The Bronx, New York, 10467, United States

WITHDRAWN

Local Institution - 017-083

The Bronx, New York, 10469, United States

NOT YET RECRUITING

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

Local Institution - 017-836

Kettering, Ohio, 45429, United States

WITHDRAWN

Local Institution - 017-916

Memphis, Tennessee, 38104, United States

WITHDRAWN

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

Dallas, Texas, 75246, United States

RECRUITING

Local Institution - Unk056

Dallas, Texas, 75390, United States

ACTIVE NOT RECRUITING

Local Institution - 017-848

Houston, Texas, 77030, United States

WITHDRAWN

Local Institution - 017-999

Irving, Texas, 75063, United States

NOT YET RECRUITING

USOR - Texas Oncology Northeast Texas - Longview Cancer Center

Longview, Texas, 75601, United States

RECRUITING

Local Institution - 017-878-B

Palestine, Texas, 75801, United States

NOT YET RECRUITING

Local Institution - 017-878-C

Paris, Texas, 75460, United States

NOT YET RECRUITING

Local Institution - 017-878-A

Tyler, Texas, 75702, United States

NOT YET RECRUITING

Local Institution - Unk010

Salt Lake City, Utah, 84106, United States

ACTIVE NOT RECRUITING

Local Institution - 017-814-A

Arlington, Virginia, 22205, United States

NOT YET RECRUITING

Local Institution - Unk066

Fairfax, Virginia, 22031, United States

ACTIVE NOT RECRUITING

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, 22031, United States

RECRUITING

Local Institution - 017-814-B

Gainesville, Virginia, 20155, United States

NOT YET RECRUITING

Local Institution - 017-814-C

Reston, Virginia, 20190, United States

NOT YET RECRUITING

PeaceHealth St. Joseph Medical Center

Bellingham, Washington, 98225, United States

RECRUITING

Local Institution - Unk036

Huntington, West Virginia, 25705, United States

ACTIVE NOT RECRUITING

Local Institution - 017-458

Natal, Rio Grande do Norte, 59062-000, Brazil

WITHDRAWN

Local Institution - 017-446

Ijuí, Rio Grande do Sul, 98700-000, Brazil

WITHDRAWN

Local Institution - 017-453

Itajaí, Santa Catarina, 88301-220, Brazil

WITHDRAWN

Local Institution - 017-457

Barretos, 14784-400, Brazil

WITHDRAWN

Local Institution - 017-442

Curitiba, 81520-060, Brazil

WITHDRAWN

Local Institution - 017-452

Fortaleza, 60810-180, Brazil

WITHDRAWN

Local Institution - 017-455

Jaú, 17210-180, Brazil

WITHDRAWN

Local Institution - 017-454

Rio de Janeiro, 22250-905, Brazil

WITHDRAWN

Local Institution - 017-456

São Paulo, 01246-000, Brazil

WITHDRAWN

Local Institution - 017-695

Viña del Mar, Región de Valparaíso, 2520612, Chile

WITHDRAWN

Local Institution - 017-697

Providencia, 7500006, Chile

WITHDRAWN

Local Institution - 017-696

Santiago, 0, Chile

WITHDRAWN

Local Institution - 017-698

Temuco, 4810469, Chile

WITHDRAWN

Institut de Cancerologie de lOuest - Angers

Angers, 49055, France

RECRUITING

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

Centre Hospitalier Intercommunal de Creteil

Créteil, 94000, France

RECRUITING

Centre Georges Francois Leclerc

Dijon, 21079, France

RECRUITING

Hopital Michallon

La Tronche, 38700, France

RECRUITING

Local Institution - 017-688

Lille, 59000, France

WITHDRAWN

Local Institution - Unk078

Lyon, 69008, France

ACTIVE NOT RECRUITING

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Local Institution - Unk067

Marseille, 13015, France

ACTIVE NOT RECRUITING

Local Institution - 017-200

Montpellier, 34090, France

WITHDRAWN

Local Institution - Unk029

Paris, 75018, France

ACTIVE NOT RECRUITING

Hopital Tenon

Paris, 75020, France

RECRUITING

Local Institution - 017-664

Paris, 75248, France

WITHDRAWN

Local Institution - 017-198

Saint-Herblain, 44805, France

WITHDRAWN

Hopital Foch

Suresnes, 92150, France

RECRUITING

Hopital Larrey

Toulouse, 31059, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Local Institution - 017-790

Batumi, 6000, Georgia

WITHDRAWN

Local Institution - 017-789

Tbilisi, 0144, Georgia

WITHDRAWN

Local Institution - 017-794

Tbilisi, 0159, Georgia

WITHDRAWN

Local Institution - 017-791

Tbilisi, 0177, Georgia

WITHDRAWN

Local Institution - 017-792

Tbilisi, 0259, Georgia

WITHDRAWN

Local Institution - 017-793

Tbilisi, 380077, Georgia

WITHDRAWN

University General Hospital of Heraklion (PAGNI)

Heraklion, 71110, Greece

RECRUITING

University General Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

Metropolitan Hospital

Piraeus, 185 47, Greece

RECRUITING

Orszagos Koranyi Pulmonologiai Intezet

Budapest, 1121, Hungary

RECRUITING

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

RECRUITING

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

RECRUITING

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

RECRUITING

Local Institution - 017-767 - B

Faenza, Ravenna, 48018, Italy

NOT YET RECRUITING

Local Institution - 017-767 - A

Lugo, Ravenna, 48022, Italy

NOT YET RECRUITING

Azienda Ospedaliera San Giuseppe Moscati - Avellino

Avellino, 83100, Italy

RECRUITING

Local Institution - 017-274

Aviano, 33081, Italy

NOT YET RECRUITING

Ospedale Santo Spirito

Casale Monferrato, 15033, Italy

RECRUITING

Azienda Ospedaliero - Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Local Institution - 017-297

Padua, 35128, Italy

WITHDRAWN

Ospedale Santa Maria delle Croci di Ravenna

Ravenna, 48121, Italy

RECRUITING

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

RECRUITING

Local Institution - 017-280

Roma, 00168, Italy

ACTIVE NOT RECRUITING

Local Institution - 017-076

Kota Bharu, Kelantan, 15586, Malaysia

WITHDRAWN

Local Institution - 017-075

Kuantan, Pahang, 25100, Malaysia

WITHDRAWN

Local Institution - 017-073

Kuala Lumpur, 50586, Malaysia

WITHDRAWN

Local Institution - 017-072

Putrajaya, 62250, Malaysia

WITHDRAWN

Local Institution - 017-381

Konin, 62-500, Poland

WITHDRAWN

Instytut MSF

Lodz, 90-302, Poland

RECRUITING

Med Polonia Sp. z o. o. - Obornicka

Poznan, 60-693, Poland

RECRUITING

Wojskowy Instytut Medyczny

Warsaw, 04-349, Poland

RECRUITING

Local Institution - 017-692

Belgrade, 11000, Serbia

WITHDRAWN

Local Institution - 017-693

Belgrade, 11000, Serbia

WITHDRAWN

Local Institution - 017-690

Belgrade, 11080, Serbia

WITHDRAWN

Local Institution - 017-691

Kamenitz, 21204, Serbia

WITHDRAWN

Local Institution - 017-694

Kragujevac, 34000, Serbia

WITHDRAWN

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

RECRUITING

Local Institution - Unk001

Málaga, 29010, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Hospital Son Llatzer

Palma de Mallorca, 07198, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Local Institution - 017-395

Geneva, 1205, Switzerland

WITHDRAWN

Local Institution - 017-132

Bang Phlat, 10700, Thailand

WITHDRAWN

Local Institution - 017-136

Bangkok, 10400, Thailand

WITHDRAWN

Local Institution - 017-135

Chom Thong, 50200, Thailand

WITHDRAWN

Local Institution - 017-137

Khon Kaen, 40002, Thailand

WITHDRAWN

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 22, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); PL (4); CH (1); IT (12); SE (5); GR (3); TH (4); ES (9); MY (4); BR (9); US (84); FR (17); HU (4); CL (4)