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Advanced NSCLCPhase 2NCT05609578

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

A Phase 2 study testing Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab and Chemotherapy: Pemetrexed in people with Advanced NSCLC and Metastatic Lung Cancer, run by Mirati Therapeutics Inc. at 94 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced NSCLC, Metastatic Lung Cancer
What is being tested?
Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab and Chemotherapy: Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
94 sitesin 7 countries
Study dates
22 Nov 2022to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

94 sites in 7 countries.

94 sites in 7 countries

United States59 sites

  • Local Institution - 017-814-A

    Arlington, Virginia, 22205

  • Local Institution - 017-872-I

    Aurora, Colorado, 80012

  • Local Institution - 017-080

    Babylon, New York, 11702

  • Local Institution - 017-909

    Bellingham, Washington, 98225

  • Local Institution - 017-388

    Boston, Massachusetts, 02215

  • Local Institution - 017-808

    Boston, Massachusetts, 02215

  • Local Institution - 017-872-G

    Boulder, Colorado, 80303

  • Local Institution - 017-088

    Brooklyn, New York, 11210

  • Local Institution - 017-972

    Chicago, Illinois, 60637

  • Local Institution - 017-818

    Cleveland, Ohio, 44195

  • Local Institution - 017-872-D

    Colorado Springs, Colorado, 80907

  • Local Institution - 017-872-J

    Colorado Springs, Colorado, 80920

  • Local Institution - 017-879

    Dallas, Texas, 75246

  • Local Institution - 017-872-B

    Denver, Colorado, 80218

  • Local Institution - 017-872-F

    Denver, Colorado, 80220

  • Local Institution - 017-587

    East Syracuse, New York, 13057

  • Local Institution - 017-814

    Fairfax, Virginia, 22031

  • Local Institution - 017-820J

    Fairway, Kansas, 66205

  • Local Institution - 017-936C

    Fountain Valley, California, 92708

  • Local Institution - 017-936

    Fountain Valley, California, 92708

  • Local Institution - 017-851

    Fullerton, California, 92835

  • Local Institution - 017-814-B

    Gainesville, Virginia, 20155

  • Local Institution - 017-829

    Jacksonville, Florida, 32224

  • Local Institution - 017-820A

    Kansas City, Kansas, 66160

  • Local Institution - 017-820B

    Kansas City, Kansas, 66160

  • Local Institution - 017-820C

    Kansas City, Kansas, 66160

  • Local Institution - 017-820H

    Kansas City, Kansas, 66160

  • Local Institution - 017-820F

    Kansas City, Missouri, 64116

  • Local Institution - 017-820E

    Kansas City, Missouri, 64154

  • Local Institution - 017-898

    Lakeland, Florida, 33812

  • Local Institution - 017-872-A

    Lakewood, Colorado, 80228

  • Local Institution - 017-820D

    Lee's Summit, Missouri, 64064

  • Local Institution - 017-872-C

    Littleton, Colorado, 80218

  • Local Institution - 017-872

    Lone Tree, Colorado, 80124

  • Local Institution - 017-878

    Longview, Texas, 75601

  • Local Institution - 017-838B

    Minneapolis, Minnesota, 55404

  • Local Institution - 017-838C

    Minneapolis, Minnesota, 55404

  • Local Institution - 017-087

    New Hyde Park, New York, 11042

  • Local Institution - 017-085

    New York, New York, 10028

  • Local Institution - 017-820G

    North Kansas City, Missouri, 64116

  • Local Institution - 017-811

    Novi, Michigan, 48377

  • Local Institution - 017-820I

    Overland Park, Kansas, 66210

  • Local Institution - 017-878-B

    Palestine, Texas, 75801

  • Local Institution - 017-878-C

    Paris, Texas, 75460

  • Local Institution - 017-082

    Patchogue, New York, 11772

  • Local Institution - 017-086

    Port Jefferson, New York, 11776

  • Local Institution - 017-081

    Port Jefferson Station, New York, 11776

  • Local Institution - 017-535

    Port Jefferson Station, New York, 11776

  • Local Institution - 017-872-E

    Pueblo, Colorado, 81003

  • Local Institution - 017-814-C

    Reston, Virginia, 20190

  • Local Institution - 017-084

    Riverhead, New York, 11901

  • Local Institution - 017-830

    Rochester, Minnesota, 55905

  • Local Institution - 017-838

    Saint Louis Park, Minnesota, 55416

  • Local Institution - 017-838A

    Saint Louis Park, Minnesota, 55426-5000

  • Local Institution - 017-540

    San Francisco, California, 94158

  • Local Institution - 017-083

    The Bronx, New York, 10469

  • Local Institution - 017-872-H

    Thornton, Colorado, 80260

  • Local Institution - 017-878-A

    Tyler, Texas, 75702

  • Local Institution - 017-820

    Westwood, Kansas, 66205

Other trials in United States

France10 sites

  • Local Institution - 017-689

    Angers, 49055

  • Local Institution - 017-196

    Caen, 14076

  • Local Institution - 017-190

    Créteil, 94000

  • Local Institution - 017-192

    Dijon, 21079

  • Local Institution - 017-683

    La Tronche, 38700

  • Local Institution - 017-199

    Marseille, 13009

  • Local Institution - 017-686

    Paris, 75020

  • Local Institution - 017-667

    Suresnes, 92150

  • Local Institution - 017-663

    Toulouse, 31059

  • Local Institution - 017-202

    Villejuif, 94805

Other trials in France

Spain8 sites

  • Local Institution - 017-613

    A Coruña, 15006

  • Local Institution - 017-619

    Madrid, 28007

  • Local Institution - 017-624

    Madrid, 28046

  • Local Institution - 017-626

    Majadahonda, 28222

  • Local Institution - 017-602

    Palma de Mallorca, 07120

  • Local Institution - 017-771

    Palma de Mallorca, 07198

  • Local Institution - 017-772

    Seville, 41009

  • Local Institution - 017-603

    Zaragoza, 50009

Other trials in Spain

Italy7 sites

  • Local Institution - 017-292

    Avellino, 83100

  • Local Institution - 017-773

    Casale Monferrato, 15033

  • Local Institution - 017-762

    Florence, 50134

  • Local Institution - 017-278

    Milan, 20141

  • Local Institution - 017-788

    Orbassano, 10043

  • Local Institution - 017-767

    Ravenna, 48121

  • Local Institution - 017-295

    Roma, 00144

Other trials in Italy

Hungary4 sites

  • Local Institution - 017-244

    Budapest, 1121

  • Local Institution - 017-241

    Budapest, 1122

  • Local Institution - 017-759

    Székesfehérvár, 8000

  • Local Institution - 017-240

    Törökbálint, 2045

Other trials in Hungary

Greece3 sites

  • Local Institution - 017-238

    Heraklion, 71110

  • Local Institution - 017-235

    Larissa, 41110

  • Local Institution - 017-234

    Piraeus, 185 47

Other trials in Greece

Poland3 sites

  • Local Institution - 017-757

    Lodz, 90-302

  • Local Institution - 017-382

    Poznan, 60-639

  • Local Institution - 017-774

    Warsaw, 04-349

Other trials in Poland

About this study

Official title: 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

Being tested
Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab, Chemotherapy: Pemetrexed, Cisplatin/Carboplatin
Keywords
KRAS G12C, NSCLC, Non Small Cell Lung Cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adagrasib oral dose of 400 mg twice daily tabletsDrug

    oral dose of 400 mg twice daily tablets

  • PembrolizumabCombination product

    IV infusion once every 3 weeks

  • Chemotherapy: PemetrexedCombination product

    IV infusion once every 3 weeks

  • Cisplatin/CarboplatinCombination product

    IV infusion once every 3 weeks

Study groups in NCT05609578
Study groupRoleWhat they receive
Cohort A: PD-L1 TPS≥ 1% (Closed)ExperimentalAdagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Receives: Drug: Adagrasib oral dose of 400 mg twice daily tablets
Cohort CExperimentalAdagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Receives: Drug: Adagrasib oral dose of 400 mg twice daily tablets; Combination Product: Pembrolizumab; Combination Product: Chemotherapy: Pemetrexed; Combination Product: Cisplatin/Carboplatin
Cohort EExperimentalAdagrasib 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)
Receives: Drug: Adagrasib oral dose of 400 mg twice daily tablets; Combination Product: Pembrolizumab; Combination Product: Chemotherapy: Pemetrexed; Combination Product: Cisplatin/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) for Cohort A and E

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

    Measured: 30 months

  2. 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.

    Measured: 30 months

Secondary outcomes (6)

  1. Adverse Events

    Defined as number of patients with treatment emergent AEs

    Measured: 30 months

  2. Duration of Response (DOR)

    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.

    Measured: 30 months

  3. Overall Survival (OS)

    Defined as time from date of first study treatment to date of death due to any cause

    Measured: 30 months

  4. Progression-free Survival (PFS)

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

    Measured: 30 months

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

    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.

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

  6. Cohorts C and E: DLTs during SLI (Safety Lead In)

    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.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start22 Nov 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609578
Sponsor's protocol ID
CA239-0010
Other IDs
849-017, CA239-0010
Status last verified
Jun 2026
First submitted
1 Nov 2022
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab and Chemotherapy: Pemetrexed in people with Advanced NSCLC and Metastatic Lung Cancer, run by Mirati Therapeutics Inc. at 94 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, France, Spain, Italy, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) for Cohort A and E (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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