Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation (202200050434)

June 18, 2026 updated by: Mirati Therapeutics Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • France
      • Angers, France, 49055
        • Local Institution - 017-689
      • Caen, France, 14076
        • Local Institution - 017-196
      • Créteil, France, 94000
        • Local Institution - 017-190
      • Dijon, France, 21079
        • Local Institution - 017-192
      • La Tronche, France, 38700
        • Local Institution - 017-683
      • Marseille, France, 13009
        • Local Institution - 017-199
      • Paris, France, 75020
        • Local Institution - 017-686
      • Suresnes, France, 92150
        • Local Institution - 017-667
      • Toulouse, France, 31059
        • Local Institution - 017-663
      • Villejuif, France, 94805
        • Local Institution - 017-202
  • Greece
      • Heraklion, Greece, 71110
        • Local Institution - 017-238
      • Larissa, Greece, 41110
        • Local Institution - 017-235
      • Piraeus, Greece, 185 47
        • Local Institution - 017-234
  • Hungary
      • Budapest, Hungary, 1121
        • Local Institution - 017-244
      • Budapest, Hungary, 1122
        • Local Institution - 017-241
      • Székesfehérvár, Hungary, 8000
        • Local Institution - 017-759
      • Törökbálint, Hungary, 2045
        • Local Institution - 017-240
  • Italy
      • Avellino, Italy, 83100
        • Local Institution - 017-292
      • Casale Monferrato, Italy, 15033
        • Local Institution - 017-773
      • Florence, Italy, 50134
        • Local Institution - 017-762
      • Milan, Italy, 20141
        • Local Institution - 017-278
      • Orbassano, Italy, 10043
        • Local Institution - 017-788
      • Ravenna, Italy, 48121
        • Local Institution - 017-767
      • Roma, Italy, 00144
        • Local Institution - 017-295
  • Poland
      • Lodz, Poland, 90-302
        • Local Institution - 017-757
      • Poznan, Poland, 60-639
        • Local Institution - 017-382
      • Warsaw, Poland, 04-349
        • Local Institution - 017-774
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 017-613
      • Madrid, Spain, 28007
        • Local Institution - 017-619
      • Madrid, Spain, 28046
        • Local Institution - 017-624
      • Majadahonda, Spain, 28222
        • Local Institution - 017-626
      • Palma de Mallorca, Spain, 07120
        • Local Institution - 017-602
      • Palma de Mallorca, Spain, 07198
        • Local Institution - 017-771
      • Seville, Spain, 41009
        • Local Institution - 017-772
      • Zaragoza, Spain, 50009
        • Local Institution - 017-603
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Local Institution - 017-936C
      • Fountain Valley, California, United States, 92708
        • Local Institution - 017-936
      • Fullerton, California, United States, 92835
        • Local Institution - 017-851
      • San Francisco, California, United States, 94158
        • Local Institution - 017-540
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Local Institution - 017-872-I
      • Boulder, Colorado, United States, 80303
        • Local Institution - 017-872-G
      • Colorado Springs, Colorado, United States, 80907
        • Local Institution - 017-872-D
      • Colorado Springs, Colorado, United States, 80920
        • Local Institution - 017-872-J
      • Denver, Colorado, United States, 80218
        • Local Institution - 017-872-B
      • Denver, Colorado, United States, 80220
        • Local Institution - 017-872-F
      • Lakewood, Colorado, United States, 80228
        • Local Institution - 017-872-A
      • Littleton, Colorado, United States, 80218
        • Local Institution - 017-872-C
      • Lone Tree, Colorado, United States, 80124
        • Local Institution - 017-872
      • Pueblo, Colorado, United States, 81003
        • Local Institution - 017-872-E
      • Thornton, Colorado, United States, 80260
        • Local Institution - 017-872-H
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 017-829
      • Lakeland, Florida, United States, 33812
        • Local Institution - 017-898
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 017-972
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Local Institution - 017-820J
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 017-820A
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 017-820B
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 017-820C
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 017-820H
      • Overland Park, Kansas, United States, 66210
        • Local Institution - 017-820I
      • Westwood, Kansas, United States, 66205
        • Local Institution - 017-820
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 017-388
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 017-808
    • Michigan
      • Novi, Michigan, United States, 48377
        • Local Institution - 017-811
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution - 017-838B
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution - 017-838C
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 017-830
      • Saint Louis Park, Minnesota, United States, 55416
        • Local Institution - 017-838
      • Saint Louis Park, Minnesota, United States, 55426-5000
        • Local Institution - 017-838A
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • Local Institution - 017-820F
      • Kansas City, Missouri, United States, 64154
        • Local Institution - 017-820E
      • Lee's Summit, Missouri, United States, 64064
        • Local Institution - 017-820D
      • North Kansas City, Missouri, United States, 64116
        • Local Institution - 017-820G
    • New York
      • Babylon, New York, United States, 11702
        • Local Institution - 017-080
      • Brooklyn, New York, United States, 11210
        • Local Institution - 017-088
      • East Syracuse, New York, United States, 13057
        • Local Institution - 017-587
      • New Hyde Park, New York, United States, 11042
        • Local Institution - 017-087
      • New York, New York, United States, 10028
        • Local Institution - 017-085
      • Patchogue, New York, United States, 11772
        • Local Institution - 017-082
      • Port Jefferson, New York, United States, 11776
        • Local Institution - 017-086
      • Port Jefferson Station, New York, United States, 11776
        • Local Institution - 017-081
      • Port Jefferson Station, New York, United States, 11776
        • Local Institution - 017-535
      • Riverhead, New York, United States, 11901
        • Local Institution - 017-084
      • The Bronx, New York, United States, 10469
        • Local Institution - 017-083
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 017-818
    • Texas
      • Dallas, Texas, United States, 75246
        • Local Institution - 017-879
      • Longview, Texas, United States, 75601
        • Local Institution - 017-878
      • Palestine, Texas, United States, 75801
        • Local Institution - 017-878-B
      • Paris, Texas, United States, 75460
        • Local Institution - 017-878-C
      • Tyler, Texas, United States, 75702
        • Local Institution - 017-878-A
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Local Institution - 017-814-A
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 017-814
      • Gainesville, Virginia, United States, 20155
        • Local Institution - 017-814-B
      • Reston, Virginia, United States, 20190
        • Local Institution - 017-814-C
    • Washington
      • Bellingham, Washington, United States, 98225
        • Local Institution - 017-909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.

  • Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received <4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
  • Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50%
  • Presence of measurable disease per RECIST v1.1

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A: PD-L1 TPS≥ 1% (Closed)
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
oral dose of 400 mg twice daily tablets
Experimental: Cohort C
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
oral dose of 400 mg twice daily tablets
Combination product: Pembrolizumab
IV infusion once every 3 weeks
Combination product: Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Combination product: Cisplatin/Carboplatin
IV infusion once every 3 weeks
Experimental: Cohort E
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
oral dose of 400 mg twice daily tablets
Combination product: Pembrolizumab
IV infusion once every 3 weeks
Combination product: Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Combination product: Cisplatin/Carboplatin
IV infusion once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) for Cohort A and E
Time Frame: 30 months
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
Time Frame: 30 months
PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 30 months
Defined as number of patients with treatment emergent AEs
30 months
Duration of Response (DOR)
Time Frame: 30 months
Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
30 months
Overall Survival (OS)
Time Frame: 30 months
Defined as time from date of first study treatment to date of death due to any cause
30 months
Progression-free Survival (PFS)
Time Frame: 30 months
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
30 months
Population pharmacokinetic (PK) Model Derived AUC at Steady State (AUCtau,ss).
Time Frame: Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months
Concentration data from this study will be pooled with other studies and exposure parameters derived using population PK methods. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed to report results from participants enrolled in the study and described in the Participant Flow module.
Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months
Cohorts C and E: DLTs during SLI (Safety Lead In)
Time Frame: 30 months
Defined as those patients in the SLI of the study who have received at least 80% of the assigned dose of adagrasib during the first cycle on study, or interrupted or discontinued study treatment during the first cycle due to a DLT.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirati Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA239-0010 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 849-017 (Other Identifier: Mirati Therapeutics Protocol ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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