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NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2029-10-31

Brief Summary

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The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.

The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Detailed Description

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The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score \<1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab

The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS \>=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and comparator arms. Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and tolerability, adagrasib PK, PROs, and correlative genomic biomarkers for the combination regimen in the study population.

MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Conditions

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Advanced Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer

Keywords

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KRAS G12C Non-small cell lung cancer NSCLC Metastatic Non-Small Cell Lung Cancer Adagrasib Krazati TPS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

MRTX849 Monotherapy, MRTX849 in Combination with Pembrolizumab and Pembrolizumab alone

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Pembrolizumab 200 mg IV Q3W

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Pembrolizumab Pembrolizumab Pemrolizumab

Eligibility Criteria

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Inclusion Criteria

* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50%
* Phase 3: Presence of evaluable or measurable disease per RECIST
* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:

1. No evidence of brain metastases
2. Untreated brain metastases not needing immediate local therapy
3. Previously treated brain metastases not needing immediate local therapy

Exclusion Criteria

* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
* Phase 2: Active brain metastases
* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:

1. Any untreated brain lesions \> 1.0 cm in size
2. Any brainstem lesions
3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
* Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Identifier Type: OTHER

Identifier Source: secondary_id

849-007

Identifier Type: OTHER

Identifier Source: secondary_id

CA239-0009

Identifier Type: -

Identifier Source: org_study_id

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Phase 2 Cohort 1a: PD-L1 TPS <1%

Adagrasib

Phase 2 Cohort 1b: PD-L1 TPS <1%

Adagrasib

Phase 2 Cohort 2: PD-L1 TPS ≥1%

Adagrasib

Phase 3 Cohort 3 Investigational Arm

Adagrasib

Phase 3 Cohort 4 Comparator Arm

Pembrolizumab

Interventions

Adagrasib

Adagrasib

Adagrasib

Adagrasib

Pembrolizumab

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Mirati Therapeutics Inc.

Responsible Party

Principal Investigators

Bristol-Myers Squibb

Locations

Local Institution - 007-777

Local Institution - 007-778

Local Institution - 007-898-B

MemorialCare - Long Beach Medical Center

TRIO - Cancer & Blood Specialty Clinic - Los Alamitos

Local Institution - 007-579

Local Institution - Unk045

San Francisco Veterans Affairs Medical Center

UCSF Helen Diller Family Comprehensive Cancer Center

Local Institution - 007-898-C

Providence Medical Group - Santa Rosa

Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)

Local Institution - 007-898-A

Local Institution - 007-872-H

Local Institution - 007-872-D

Local Institution - 007-872-L

Local Institution - 007-872-C

Local Institution - 007-872-K

Local Institution - 007-872-E

Local Institution - 007-872-I

Local Institution - 007-872-A

Local Institution - 007-872-J

USOR - Rocky Mountain Cancer Centers - Lone Tree

Local Institution - 007-872-G

Local Institution - 007-872-B

Local Institution - 007-872-F

Local Institution - 007-942-B

Local Institution - 007-942-D

Local Institution - 007-942-E

Local Institution - 007-942-F

Local Institution - 007-942-G

Eastern Connecticut Hematology and Oncology Associates

Local Institution - 007-942-H

MidAmerica Cancer Care - Research

Local Institution - 007-942-I

Local Institution - 007-942-J

Local Institution - 007-942-K

Local Institution - 007-5476

GenesisCare USA

Bay Pines Veterans Affairs Healthcare System

Local Institution - 007-922-A

Local Institution - 007-922-D

Local Institution - 007-922-E

Local Institution - 007-896-A

Local Institution - 007-926-B