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RECRUITING

NCT04613596

PHASE2/PHASE3

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

Sponsor: Mirati Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

626

Start Date

2020-12-02

Completion Date

2029-10-31

Last Updated

2026-10-30

Healthy Volunteers

Conditions

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

Interventions

DRUG

Adagrasib

Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

DRUG

Adagrasib

Adagrasib 600 mg BID monotherapy (Cohort 1b)

DRUG

Adagrasib

adagrasib 400 mg BID in combination with pembrolizumab

DRUG

Adagrasib

Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV Q3W

Locations (770)

Local Institution - 007-556-A

Goodyear, Arizona, United States

USOR - Arizona Oncology - Prescott Valley

Prescott Valley, Arizona, United States

Local Institution - 007-568-A

Safford, Arizona, United States

Local Institution - 007-568-B

Safford, Arizona, United States

Local Institution - 007-568-C

Safford, Arizona, United States

Local Institution - 007-568-D

Safford, Arizona, United States

Local Institution - 007-568-E

Safford, Arizona, United States

Arizona Clinical Research Center

Tucson, Arizona, United States

Highlands Oncology Group - Springdale

Springdale, Arkansas, United States

Providence - Saint Joseph Home Health - Anaheim

Anaheim, California, United States

The Oncology Institute of Hope and Innovation - Corporate Office

Cerritos, California, United States

Local Institution - 007-777

Fountain Valley, California, United States

Local Institution - 007-778

Laguna Hills, California, United States

Local Institution - 007-898-B

Long Beach, California, United States

MemorialCare - Long Beach Medical Center

Long Beach, California, United States

TRIO - Cancer & Blood Specialty Clinic - Los Alamitos

Los Alamitos, California, United States

Local Institution - 007-579

Los Angeles, California, United States

Local Institution - Unk045

Rancho Mirage, California, United States

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Local Institution - 007-898-C

Santa Ana, California, United States

Providence Medical Group - Santa Rosa

Santa Rosa, California, United States

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

Stockton, California, United States

Local Institution - 007-898-A

Whittier, California, United States

Local Institution - 007-872-H

Aurora, Colorado, United States

Local Institution - 007-872-D

Boulder, Colorado, United States

Local Institution - 007-872-L

Centennial, Colorado, United States

Local Institution - 007-872-C

Colorado Springs, Colorado, United States

Local Institution - 007-872-K

Colorado Springs, Colorado, United States

Local Institution - 007-872-E

Denver, Colorado, United States

Local Institution - 007-872-I

Denver, Colorado, United States

Local Institution - 007-872-A

Lakewood, Colorado, United States

Local Institution - 007-872-J

Littleton, Colorado, United States

USOR - Rocky Mountain Cancer Centers - Lone Tree

Lone Tree, Colorado, United States

Local Institution - 007-872-G

Longmont, Colorado, United States

Local Institution - 007-872-B

Pueblo, Colorado, United States

Local Institution - 007-872-F

Thornton, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Local Institution - 007-5476

Washington D.C., District of Columbia, United States

GenesisCare USA

Aventura, Florida, United States

Bay Pines Veterans Affairs Healthcare System

Bay Pines, Florida, United States

Local Institution - 007-922-A

Bonita Springs, Florida, United States

Local Institution - 007-922-D

Bradenton, Florida, United States

Local Institution - 007-922-E

Cape Coral, Florida, United States

Local Institution - 007-896-A

Celebration, Florida, United States

Local Institution - 007-926-B

Daytona Beach, Florida, United States

Local Institution - 007-562-B

Fleming Island, Florida, United States

SCRI - Florida Cancer Specialists - South Region Research Office

Fort Myers, Florida, United States

Local Institution - 007-922-B

Fort Myers, Florida, United States

Local Institution - 007-922-C

Fort Myers, Florida, United States

21st Century Oncology of Jacksonville - North Lee Street