Spots Global Cancer Trial Database for KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC
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Trial Identification
Brief Title: KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC
Official Title: A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT04265534
Study Description
Brief Summary: This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy for first line treatment of metastatic disease in patients with KEAP1/NRF2-mutated, stage IV, nonsquamous, non-small cell lung cancer (NSCLC). The study primary endpoints are PFS per RECIST v. 1.1 and safety. KEAP1/NRF2 mutation status (for eligibility) and STK11/LKB1 status (for stratification) will be determined by next generation sequencing. A commercial liquid biopsy (circulating tumor DNA) NGS test will be provided to study participants free of charge.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of South Alabama - Mitchell Cancer Center, Mobile, Alabama, United States
Yuma Regional Medical Center, Yuma, Arizona, United States
Compassionate Cancer Care, Fountain Valley, California, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
University of Southern California (USC), Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
UCLA, Los Angeles, California, United States
University of California Irvine, Chao Family Comprehensive Cancer Center, Orange, California, United States
St. Joseph Heritage Healthcare - Santa Rosa, Santa Rosa, California, United States
Johns Hopkins Sibley Memorial Hospital, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Boca Raton Regional Hospital Lynn Cancer Institute, Boca Raton, Florida, United States
Holy Cross Hospital - Bines Cancer Center, Fort Lauderdale, Florida, United States
Florida Cancer Specialist - South (SCRI), Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial Hospital West, Hollywood, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Florida Cancer Specialist - North (SCRI), Saint Petersburg, Florida, United States
Florida Cancer Specialist - Panhandle (SCRI), Tallahassee, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Florida Cancer Specialist - East (SCRI), West Palm Beach, Florida, United States
University Cancer and Blood Center, Athens, Georgia, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Emory University Hospital, Atlanta, Georgia, United States
Northwest Georgia Oncology, Marietta, Georgia, United States
Hawaii Cancer Care, Honolulu, Hawaii, United States
Oncology of Northshore, Rolling Meadows, Illinois, United States
Orchard Healthcare Research Inc., Skokie, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Beacon Health, South Bend, Indiana, United States
University of Kansas Medical Center (KUMC), Westwood, Kansas, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
Johns Hopkins Bayview Memorial Hospital, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Maryland Oncology Hematology - USOR, Columbia, Maryland, United States
Frederick Health - James M. Stockman Cancer Institute, Frederick, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Bronson Methodist Hospital (West Michigan Cancer Center), Kalamazoo, Michigan, United States
St. Joseph Mercy Hospital Cancer Care Center, Ypsilanti, Michigan, United States
Minnesota Oncology Hematology, P.A., Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, P.A., Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A., Maplewood, Minnesota, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
Minnesota Oncology Hematology, P.A., Saint Paul, Minnesota, United States
Minnesota Oncology Hematology, P.A., Woodbury, Minnesota, United States
Central Care Cancer Center, Bolivar, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
New Jersey Cancer Care and Blood Disorders (NJCCBD), Belleville, New Jersey, United States
Summit Medical Group, Berkeley Heights, New Jersey, United States
The Valley Hospital - Luckow Pavilion, Paramus, New Jersey, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.), Albany, New York, United States
New York Oncology Hematology, P.C. (43 New Scotland Ave.), Albany, New York, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
New York Oncology Hematology, P.C., Clifton Park, New York, United States
Pelmutter Cancer Center at Winthrop, Mineola, New York, United States
New York University Langone (NYU), New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
Cone Health at Alamance Regional, Burlington, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Aultman Hospital, Canton, Ohio, United States
TriHealth Cancer Institute, Cincinnati, Ohio, United States
Ohio State University, James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
Ohio Health, Columbus, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Oklahoma Cancer Specialists and Research Institute (OCSRI), Tulsa, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health & Science University (OHSU) Knight Cancer Institute, Portland, Oregon, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Pennsylvania State University Milton S. Hershey Medical Center, State College, Pennsylvania, United States
Sanford Health, Sioux Falls, South Dakota, United States
Tennessee Oncology - Chattanooga (SCRI), Chattanooga, Tennessee, United States
Tennessee Oncology - Nashville (SCRI), Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Austin Central, Austin, Texas, United States
Texas Oncology - South Austin, Austin, Texas, United States
Texas Oncology Beaumont - USOR, Beaumont, Texas, United States
Texas Oncology - Denison, Denison, Texas, United States
Texas Oncology - Fort Worth Cancer Center, Fort Worth, Texas, United States
Oncology Consultants, Houston, Texas, United States
Oncology and Hematology of South Texas, Laredo, Texas, United States
Utah Cancer Specialist, Salt Lake City, Utah, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Blacksburg, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Low Moor, Virginia, United States
Virginia Commonwealth University (VCU) Massey Cancer Center, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Roanoke, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Salem, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Wytheville, Virginia, United States
University of Washington Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States
Northwest Medical Specialities, Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Froedtert Hospital and the Medical College of Wisconsin (MCW), Milwaukee, Wisconsin, United States
Contact Details
Name: Emil Kuriakose, MD
Affiliation: Calithera Biosciences, Inc
Role: STUDY_DIRECTOR
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