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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.
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
2026-08-25
Healthy Volunteers
No
Interventions
Adagrasib
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
Adagrasib
Adagrasib 600 mg BID monotherapy (Cohort 1b)
Adagrasib
adagrasib 400 mg BID in combination with pembrolizumab
Adagrasib
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
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
Jacksonville, Florida, United States
Local Institution - 007-562-D
Jacksonville, Florida, United States
Local Institution - 007-562-E
Jacksonville, Florida, United States
Local Institution - 007-562-G
Jacksonville, Florida, United States
Local Institution - 007-829
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States
Local Institution - 007-562-C
Jacksonville, Florida, United States
Local Institution - 007-562-F
Jacksonville Beach, Florida, United States
Miami Veterans Affairs Healthcare System
Miami, Florida, United States
Local Institution - 007-922-F
Naples, Florida, United States
Local Institution - 007-922-G
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
USOR - Woodlands Medical Specialists
Pensacola, Florida, United States
Local Institution - 007-922-H
Port Charlotte, Florida, United States
Local Institution - 007-562-A
Saint Augustine, Florida, United States
Local Institution - 007-922-I
Sarasota, Florida, United States
Local Institution - 007-922-J
Sarasota, Florida, United States
Local Institution - 007-926-D
Stuart, Florida, United States
Local Institution - 007-924-A
Tallahassee, Florida, United States
SCRI - Florida Cancer Specialists - Tallahassee Cancer Center
Tallahassee, Florida, United States
James A. Haley Veterans Hospital
Tampa, Florida, United States
Local Institution - Unk065
Tampa, Florida, United States
Local Institution - 007-922-L
Venice, Florida, United States
Local Institution - 007-922-K
Venice, Florida, United States
Local Institution - 007-926-C
Vero Beach, Florida, United States
Local Institution - 007-926-A
Wellington, Florida, United States
SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach, Florida, United States
Local Institution - Unk072
Weston, Florida, United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States
Local Institution - Unk052
Atlanta, Georgia, United States
Local Institution - 007-786-C
Carrollton, Georgia, United States
Local Institution - 007-786-A
Cartersville, Georgia, United States
Local Institution - 007-786-D
Douglasville, Georgia, United States
Local Institution - 007-786-B
Hiram, Georgia, United States
Central Georgia Cancer Care - Macon
Macon, Georgia, United States
Northwest Georgia Oncology Centers Wellstar - Marietta
Marietta, Georgia, United States
Local Institution - 007-897
Honolulu, Hawaii, United States
Local Institution - Unk005
Honolulu, Hawaii, United States
Local Institution - 007-883-A
Arlington Heights, Illinois, United States
Local Institution - 007-955
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
USOR - Illinois Cancer Specialists - Niles
Niles, Illinois, United States
Advocate Medical Group Oncology
Park Ridge, Illinois, United States
Local Institution - Unk061
Peoria, Illinois, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Local Institution - 007-942-B
Chanute, Kansas, United States
Local Institution - 007-942-D
El Dorado, Kansas, United States
Local Institution - 007-942-E
Independence, Kansas, United States
Local Institution - 007-942-F
Kingman, Kansas, United States
Local Institution - 007-942-G
Liberal, Kansas, United States
Local Institution - 007-942-H
McPherson, Kansas, United States
MidAmerica Cancer Care - Research
Merriam, Kansas, United States
Local Institution - 007-942-I
Newton, Kansas, United States
Local Institution - 007-942-J
Parsons, Kansas, United States
Local Institution - 007-942-K
Pratt, Kansas, United States
Local Institution - 007-942-L
Salina, Kansas, United States
Local Institution - 007-942-M
Wellington, Kansas, United States
Local Institution - Unk032
Westwood, Kansas, United States
Local Institution - 007-942-A
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita - Heritage Plaza
Wichita, Kansas, United States
Local Institution - 007-942-N
Winfield, Kansas, United States
Lexington Medical Cancer Center Hematology/Oncology
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Local Institution - 007-388-A
Louisville, Kentucky, United States
Local Institution - Unk011
Baton Rouge, Louisiana, United States
Local Institution - 007-994-A
Covington, Louisiana, United States
Pontchartrain Cancer Center - Covington Office
Covington, Louisiana, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute at St. Elizabeths Medical Center
Brighton, Massachusetts, United States
Brigham and Womens/Mass General Health Care Center at Foxborough
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, United States
Dana-Farber Brigham and Womens Cancer Center at Milford Regional
Milford, Massachusetts, United States
Dana-Farber Brigham Cancer Center at South Shore Health
South Weymouth, Massachusetts, United States
USOR - Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Local Institution - 007-589A
Edina, Minnesota, United States
Local Institution - Unk006
Minneapolis, Minnesota, United States
Local Institution - 007-822
Minneapolis, Minnesota, United States
Local Institution - 007-830
Rochester, Minnesota, United States
Jackson Oncology Associates - The Hederman Cancer Center
Jackson, Mississippi, United States
Local Institution - 007-590D
Grand Island, Nebraska, United States
Local Institution - 007-590A
Omaha, Nebraska, United States
Local Institution - 007-590B
Omaha, Nebraska, United States
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, Nebraska, United States
Local Institution - 007-590C
Papillion, Nebraska, United States
OptumCare Nevada
Las Vegas, Nevada, United States
Local Institution - 007-938A
Las Vegas, Nevada, United States
Local Institution - 007-938B
Las Vegas, Nevada, United States
Local Institution - 007-993
Belleville, New Jersey, United States
Astera Cancer Care - East Brunswick