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

NCT05609578 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CA239-0010849-017
• Study Type: interventional
• Target: 90
• Locations: 7 countries
• Sites: 94

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 (94)

Local Institution - 017-936C

Fountain Valley, California, 92708, United States

Location

Local Institution - 017-936

Fountain Valley, California, 92708, United States

Location

Local Institution - 017-851

Fullerton, California, 92835, United States

Location

Local Institution - 017-540

San Francisco, California, 94158, United States

Location

Local Institution - 017-872-I

Aurora, Colorado, 80012, United States

Location

Local Institution - 017-872-G

Boulder, Colorado, 80303, United States

Location

Local Institution - 017-872-D

Colorado Springs, Colorado, 80907, United States

Location

Local Institution - 017-872-J

Colorado Springs, Colorado, 80920, United States

Location

Local Institution - 017-872-B

Denver, Colorado, 80218, United States

Location

Local Institution - 017-872-F

Denver, Colorado, 80220, United States

Location

Local Institution - 017-872-A

Lakewood, Colorado, 80228, United States

Location

Local Institution - 017-872-C

Littleton, Colorado, 80218, United States

Location

Local Institution - 017-872

Lone Tree, Colorado, 80124, United States

Location

Local Institution - 017-872-E

Pueblo, Colorado, 81003, United States

Location

Local Institution - 017-872-H

Thornton, Colorado, 80260, United States

Location

Local Institution - 017-829

Jacksonville, Florida, 32224, United States

Location

Local Institution - 017-898

Lakeland, Florida, 33812, United States

Location

Local Institution - 017-972

Chicago, Illinois, 60637, United States

Location

Local Institution - 017-820J

Fairway, Kansas, 66205, United States

Location

Local Institution - 017-820A

Kansas City, Kansas, 66160, United States

Location

Local Institution - 017-820B

Kansas City, Kansas, 66160, United States

Location

Local Institution - 017-820C

Kansas City, Kansas, 66160, United States

Location

Local Institution - 017-820H

Kansas City, Kansas, 66160, United States

Location

Local Institution - 017-820I

Overland Park, Kansas, 66210, United States

Location

Local Institution - 017-820

Westwood, Kansas, 66205, United States

Location

Local Institution - 017-388

Boston, Massachusetts, 02215, United States

Location

Local Institution - 017-808

Boston, Massachusetts, 02215, United States

Location

Local Institution - 017-811

Novi, Michigan, 48377, United States

Location

Local Institution - 017-838B

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 017-838C

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 017-830

Rochester, Minnesota, 55905, United States

Location

Local Institution - 017-838

Saint Louis Park, Minnesota, 55416, United States

Location

Local Institution - 017-838A

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

Location

Local Institution - 017-820F

Kansas City, Missouri, 64116, United States

Location

Local Institution - 017-820E

Kansas City, Missouri, 64154, United States

Location

Local Institution - 017-820D

Lee's Summit, Missouri, 64064, United States

Location

Local Institution - 017-820G

North Kansas City, Missouri, 64116, United States

Location

Local Institution - 017-080

Babylon, New York, 11702, United States

Location

Local Institution - 017-088

Brooklyn, New York, 11210, United States

Location

Local Institution - 017-587

East Syracuse, New York, 13057, United States

Location

Local Institution - 017-087

New Hyde Park, New York, 11042, United States

Location

Local Institution - 017-085

New York, New York, 10028, United States

Location

Local Institution - 017-082

Patchogue, New York, 11772, United States

Location

Local Institution - 017-086

Port Jefferson, New York, 11776, United States

Location

Local Institution - 017-081

Port Jefferson Station, New York, 11776, United States

Location

Local Institution - 017-535

Port Jefferson Station, New York, 11776, United States

Location

Local Institution - 017-084

Riverhead, New York, 11901, United States

Location

Local Institution - 017-083

The Bronx, New York, 10469, United States

Location

Local Institution - 017-818

Cleveland, Ohio, 44195, United States

Location

Local Institution - 017-879

Dallas, Texas, 75246, United States

Location

Local Institution - 017-878

Longview, Texas, 75601, United States

Location

Local Institution - 017-878-B

Palestine, Texas, 75801, United States

Location

Local Institution - 017-878-C

Paris, Texas, 75460, United States

Location

Local Institution - 017-878-A

Tyler, Texas, 75702, United States

Location

Local Institution - 017-814-A

Arlington, Virginia, 22205, United States

Location

Local Institution - 017-814

Fairfax, Virginia, 22031, United States

Location

Local Institution - 017-814-B

Gainesville, Virginia, 20155, United States

Location

Local Institution - 017-814-C

Reston, Virginia, 20190, United States

Location

Local Institution - 017-909

Bellingham, Washington, 98225, United States

Location

Local Institution - 017-689

Angers, 49055, France

Location

Local Institution - 017-196

Caen, 14076, France

Location

Local Institution - 017-190

Créteil, 94000, France

Location

Local Institution - 017-192

Dijon, 21079, France

Location

Local Institution - 017-683

La Tronche, 38700, France

Location

Local Institution - 017-199

Marseille, 13009, France

Location

Local Institution - 017-686

Paris, 75020, France

Location

Local Institution - 017-667

Suresnes, 92150, France

Location

Local Institution - 017-663

Toulouse, 31059, France

Location

Local Institution - 017-202

Villejuif, 94805, France

Location

Local Institution - 017-238

Heraklion, 71110, Greece

Location

Local Institution - 017-235

Larissa, 41110, Greece

Location

Local Institution - 017-234

Piraeus, 185 47, Greece

Location

Local Institution - 017-244

Budapest, 1121, Hungary

Location

Local Institution - 017-241

Budapest, 1122, Hungary

Location

Local Institution - 017-759

Székesfehérvár, 8000, Hungary

Location

Local Institution - 017-240

Törökbálint, 2045, Hungary

Location

Local Institution - 017-292

Avellino, 83100, Italy

Location

Local Institution - 017-773

Casale Monferrato, 15033, Italy

Location

Local Institution - 017-762

Florence, 50134, Italy

Location

Local Institution - 017-278

Milan, 20141, Italy

Location

Local Institution - 017-788

Orbassano, 10043, Italy

Location

Local Institution - 017-767

Ravenna, 48121, Italy

Location

Local Institution - 017-295

Roma, 00144, Italy

Location

Local Institution - 017-757

Lodz, 90-302, Poland

Location

Local Institution - 017-382

Poznan, 60-639, Poland

Location

Local Institution - 017-774

Warsaw, 04-349, Poland

Location

Local Institution - 017-613

A Coruña, 15006, Spain

Location

Local Institution - 017-619

Madrid, 28007, Spain

Location

Local Institution - 017-624

Madrid, 28046, Spain

Location

Local Institution - 017-626

Majadahonda, 28222, Spain

Location

Local Institution - 017-602

Palma de Mallorca, 07120, Spain

Location

Local Institution - 017-771

Palma de Mallorca, 07198, Spain

Location

Local Institution - 017-772

Seville, 41009, Spain

Location

Local Institution - 017-603

Zaragoza, 50009, Spain

Location

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

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): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

PL (3); IT (7); GR (3); ES (8); US (59); FR (10); HU (4)