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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAdagrasib oral dose of 400 mg twice daily tablets and Pembrolizumab

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?94 U.S. locations

Locations may change over time.

Who runs it?Mirati Therapeutics Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Mirati Therapeutics Inc.
Interventions being studied: Drug: Adagrasib oral dose of 400 mg twice daily tablets; Combination Product: Pembrolizumab; Combination Product: Chemotherapy: Pemetrexed; Combination Product: Cisplatin/Carboplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

KRAS→

Treatment approach

Immunotherapy→Targeted therapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 017-936CFountain Valley, California
Local Institution - 017-936Fountain Valley, California
Local Institution - 017-851Fullerton, California
Local Institution - 017-540San Francisco, California
Local Institution - 017-872-IAurora, Colorado
Local Institution - 017-872-GBoulder, Colorado
Local Institution - 017-872-DColorado Springs, Colorado
Local Institution - 017-872-JColorado Springs, Colorado
Local Institution - 017-872-BDenver, Colorado
Local Institution - 017-872-FDenver, Colorado
Local Institution - 017-872-ALakewood, Colorado
Local Institution - 017-872-CLittleton, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 23, 2026. Always confirm current availability with the study team.

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