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New drug cocktail targets Hard-to-Treat lung cancer mutation

NCT ID NCT05609578

Disease control Sponsor: Mirati Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether combining the targeted drug adagrasib with immunotherapy (pembrolizumab) and chemotherapy can shrink tumors or delay progression in people with advanced non-small cell lung cancer that has a specific KRAS G12C mutation. The study enrolls adults whose cancer has not been treated before and whose tumors show at least some PD-L1 protein. Researchers will measure how many patients respond and how long the benefit lasts, while monitoring side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adagrasib
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with a specific genetic subtype of advanced lung cancer.
What could go wrong
This is an early-phase trial with a small number of participants. The drug combination may cause significant side effects, and results may not lead to a widely approved therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lung neoplasm metastatic malignant neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced NSCLC Metastatic lung cancer

Contacts and locations

Locations

  • Local Institution - 017-080

    Babylon, New York, 11702, United States

  • Local Institution - 017-081

    Port Jefferson Station, New York, 11776, United States

  • Local Institution - 017-082

    Patchogue, New York, 11772, United States

  • Local Institution - 017-083

    The Bronx, New York, 10469, United States

  • Local Institution - 017-084

    Riverhead, New York, 11901, United States

  • Local Institution - 017-085

    New York, New York, 10028, United States

  • Local Institution - 017-086

    Port Jefferson, New York, 11776, United States

  • Local Institution - 017-087

    New Hyde Park, New York, 11042, United States

  • Local Institution - 017-088

    Brooklyn, New York, 11210, United States

  • Local Institution - 017-190

    Créteil, 94000, France

  • Local Institution - 017-192

    Dijon, 21079, France

  • Local Institution - 017-196

    Caen, 14076, France

  • Local Institution - 017-199

    Marseille, 13009, France

  • Local Institution - 017-202

    Villejuif, 94805, France

  • Local Institution - 017-234

    Piraeus, 185 47, Greece

  • Local Institution - 017-235

    Larissa, 41110, Greece

  • Local Institution - 017-238

    Heraklion, 71110, Greece

  • Local Institution - 017-240

    Törökbálint, 2045, Hungary

  • Local Institution - 017-241

    Budapest, 1122, Hungary

  • Local Institution - 017-244

    Budapest, 1121, Hungary

  • Local Institution - 017-278

    Milan, 20141, Italy

  • Local Institution - 017-292

    Avellino, 83100, Italy

  • Local Institution - 017-295

    Roma, 00144, Italy

  • Local Institution - 017-382

    Poznan, 60-639, Poland

  • Local Institution - 017-388

    Boston, Massachusetts, 02215, United States

  • Local Institution - 017-535

    Port Jefferson Station, New York, 11776, United States

  • Local Institution - 017-540

    San Francisco, California, 94158, United States

  • Local Institution - 017-587

    East Syracuse, New York, 13057, United States

  • Local Institution - 017-602

    Palma de Mallorca, 07120, Spain

  • Local Institution - 017-603

    Zaragoza, 50009, Spain

  • Local Institution - 017-613

    A Coruña, 15006, Spain

  • Local Institution - 017-619

    Madrid, 28007, Spain

  • Local Institution - 017-624

    Madrid, 28046, Spain

  • Local Institution - 017-626

    Majadahonda, 28222, Spain

  • Local Institution - 017-663

    Toulouse, 31059, France

  • Local Institution - 017-667

    Suresnes, 92150, France

  • Local Institution - 017-683

    La Tronche, 38700, France

  • Local Institution - 017-686

    Paris, 75020, France

  • Local Institution - 017-689

    Angers, 49055, France

  • Local Institution - 017-757

    Lodz, 90-302, Poland

  • Local Institution - 017-759

    Székesfehérvár, 8000, Hungary

  • Local Institution - 017-762

    Florence, 50134, Italy

  • Local Institution - 017-767

    Ravenna, 48121, Italy

  • Local Institution - 017-771

    Palma de Mallorca, 07198, Spain

  • Local Institution - 017-772

    Seville, 41009, Spain

  • Local Institution - 017-773

    Casale Monferrato, 15033, Italy

  • Local Institution - 017-774

    Warsaw, 04-349, Poland

  • Local Institution - 017-788

    Orbassano, 10043, Italy

  • Local Institution - 017-808

    Boston, Massachusetts, 02215, United States

  • Local Institution - 017-811

    Novi, Michigan, 48377, United States

  • Local Institution - 017-814

    Fairfax, Virginia, 22031, United States

  • Local Institution - 017-814-A

    Arlington, Virginia, 22205, United States

  • Local Institution - 017-814-B

    Gainesville, Virginia, 20155, United States

  • Local Institution - 017-814-C

    Reston, Virginia, 20190, United States

  • Local Institution - 017-818

    Cleveland, Ohio, 44195, United States

  • Local Institution - 017-820

    Westwood, Kansas, 66205, United States

  • Local Institution - 017-820A

    Kansas City, Kansas, 66160, United States

  • Local Institution - 017-820B

    Kansas City, Kansas, 66160, United States

  • Local Institution - 017-820C

    Kansas City, Kansas, 66160, United States

  • Local Institution - 017-820D

    Lee's Summit, Missouri, 64064, United States

  • Local Institution - 017-820E

    Kansas City, Missouri, 64154, United States

  • Local Institution - 017-820F

    Kansas City, Missouri, 64116, United States

  • Local Institution - 017-820G

    North Kansas City, Missouri, 64116, United States

  • Local Institution - 017-820H

    Kansas City, Kansas, 66160, United States

  • Local Institution - 017-820I

    Overland Park, Kansas, 66210, United States

  • Local Institution - 017-820J

    Fairway, Kansas, 66205, United States

  • Local Institution - 017-829

    Jacksonville, Florida, 32224, United States

  • Local Institution - 017-830

    Rochester, Minnesota, 55905, United States

  • Local Institution - 017-838

    Saint Louis Park, Minnesota, 55416, United States

  • Local Institution - 017-838A

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

  • Local Institution - 017-838B

    Minneapolis, Minnesota, 55404, United States

  • Local Institution - 017-838C

    Minneapolis, Minnesota, 55404, United States

  • Local Institution - 017-851

    Fullerton, California, 92835, United States

  • Local Institution - 017-872

    Lone Tree, Colorado, 80124, United States

  • Local Institution - 017-872-A

    Lakewood, Colorado, 80228, United States

  • Local Institution - 017-872-B

    Denver, Colorado, 80218, United States

  • Local Institution - 017-872-C

    Littleton, Colorado, 80218, United States

  • Local Institution - 017-872-D

    Colorado Springs, Colorado, 80907, United States

  • Local Institution - 017-872-E

    Pueblo, Colorado, 81003, United States

  • Local Institution - 017-872-F

    Denver, Colorado, 80220, United States

  • Local Institution - 017-872-G

    Boulder, Colorado, 80303, United States

  • Local Institution - 017-872-H

    Thornton, Colorado, 80260, United States

  • Local Institution - 017-872-I

    Aurora, Colorado, 80012, United States

  • Local Institution - 017-872-J

    Colorado Springs, Colorado, 80920, United States

  • Local Institution - 017-878

    Longview, Texas, 75601, United States

  • Local Institution - 017-878-A

    Tyler, Texas, 75702, United States

  • Local Institution - 017-878-B

    Palestine, Texas, 75801, United States

  • Local Institution - 017-878-C

    Paris, Texas, 75460, United States

  • Local Institution - 017-879

    Dallas, Texas, 75246, United States

  • Local Institution - 017-898

    Lakeland, Florida, 33812, United States

  • Local Institution - 017-909

    Bellingham, Washington, 98225, United States

  • Local Institution - 017-936

    Fountain Valley, California, 92708, United States

  • Local Institution - 017-936C

    Fountain Valley, California, 92708, United States

  • Local Institution - 017-972

    Chicago, Illinois, 60637, United States

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