KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC

PHASE2TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 24, 2020

Primary Completion Date

November 5, 2021

Study Completion Date

February 9, 2022

Conditions
Non-Small Cell Lung CancerNon-squamous Non-small-cell Lung CancerNon-Squamous Non-Small Cell Neoplasm of LungKEAP1 Gene MutationNRF2 Gene MutationNFE2L2 Gene Mutation
Interventions
DRUG

Telaglenastat

Oral Glutaminase Inhibitor

DRUG

Carboplatin Chemotherapy

IV infusion

DRUG

Pemetrexed Chemotherapy

IV infusion

BIOLOGICAL

Pembrolizumab Immunotherapy

IV infusion

DRUG

Placebo

Oral placebo

DIETARY_SUPPLEMENT

Folic acid 400 -1000 μg

Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.

DIETARY_SUPPLEMENT

Vitamin B12 1000 μg

Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.

DRUG

Dexamethasone 4 mg

For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Trial Locations (102)

10016

New York University Langone (NYU), New York

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical College - New York Presbyterian Hospital, New York

11501

Pelmutter Cancer Center at Winthrop, Mineola

12065

New York Oncology Hematology, P.C., Clifton Park

12206

New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.), Albany

12208

New York Oncology Hematology, P.C. (43 New Scotland Ave.), Albany

14263

Roswell Park Comprehensive Cancer Center, Buffalo

15232

UPMC Hillman Cancer Center, Pittsburgh

16801

Pennsylvania State University Milton S. Hershey Medical Center, State College

20016

Johns Hopkins Sibley Memorial Hospital, Washington D.C.

Sibley Memorial Hospital, Washington D.C.

20817

Center for Cancer and Blood Disorders, Bethesda

21044

Maryland Oncology Hematology - USOR, Columbia

21224

Johns Hopkins Bayview Memorial Hospital, Baltimore

21702

Frederick Health - James M. Stockman Cancer Institute, Frederick

22031

Virginia Cancer Specialists, Fairfax

23298

Virginia Commonwealth University (VCU) Massey Cancer Center, Richmond

24014

Oncology and Hematology Associates of Southwest Virginia, Roanoke

24060

Oncology and Hematology Associates of Southwest Virginia, Blacksburg

24153

Oncology and Hematology Associates of Southwest Virginia, Salem

24382

Oncology and Hematology Associates of Southwest Virginia, Wytheville

24457

Oncology and Hematology Associates of Southwest Virginia, Low Moor

27215

Cone Health at Alamance Regional, Burlington

27403

Cone Health Cancer Center, Greensboro

30060

Northwest Georgia Oncology, Marietta

30318

Piedmont Cancer Institute, Atlanta

30322

Emory University Hospital, Atlanta

30607

University Cancer and Blood Center, Athens

32308

Florida Cancer Specialist - Panhandle (SCRI), Tallahassee

33021

Memorial Cancer Institute at Memorial Hospital West, Hollywood

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

33308

Holy Cross Hospital - Bines Cancer Center, Fort Lauderdale

33401

Florida Cancer Specialist - East (SCRI), West Palm Beach

33486

Boca Raton Regional Hospital Lynn Cancer Institute, Boca Raton

33612

Moffitt Cancer Center, Tampa

33705

Florida Cancer Specialist - North (SCRI), St. Petersburg

33901

Florida Cancer Specialist - South (SCRI), Fort Myers

34474

Ocala Oncology Center, Ocala

35294

University of Alabama at Birmingham, Birmingham

36604

University of South Alabama - Mitchell Cancer Center, Mobile

37203

Tennessee Oncology - Nashville (SCRI), Nashville

37404

Tennessee Oncology - Chattanooga (SCRI), Chattanooga

43210

Ohio State University, James Cancer Hospital and Solove Research Institute, Columbus

43214

Ohio Health, Columbus

43623

Toledo Clinic Cancer Center, Toledo

44710

Aultman Hospital, Canton

45220

TriHealth Cancer Institute, Cincinnati

46601

Beacon Health, South Bend

46804

Fort Wayne Medical Oncology and Hematology, Fort Wayne

48197

St. Joseph Mercy Hospital Cancer Care Center, Ypsilanti

48202

Henry Ford Cancer Institute, Detroit

49001

Bronson Methodist Hospital (West Michigan Cancer Center), Kalamazoo

53226

Froedtert Hospital and the Medical College of Wisconsin (MCW), Milwaukee

53705

University of Wisconsin Carbone Cancer Center, Madison

55102

Minnesota Oncology Hematology, P.A., Saint Paul

55109

Minnesota Oncology Hematology, P.A., Maplewood

55125

Minnesota Oncology Hematology, P.A., Woodbury

55404

Minnesota Oncology Hematology, P.A., Minneapolis

55433

Minnesota Oncology Hematology, P.A., Coon Rapids

55435

Minnesota Oncology Hematology, P.A., Edina

57104

Sanford Health, Sioux Falls

60008

Oncology of Northshore, Rolling Meadows

60077

Orchard Healthcare Research Inc., Skokie

63110

Washington University, St Louis

65613

Central Care Cancer Center, Bolivar

66205

University of Kansas Medical Center (KUMC), Westwood

68114

Nebraska Methodist Hospital, Omaha

70443

Pontchartrain Cancer Center, Covington

74146

Oklahoma Cancer Specialists and Research Institute (OCSRI), Tulsa

75020

Texas Oncology - Denison, Denison

76104

Texas Oncology - Fort Worth Cancer Center, Fort Worth

77701

Texas Oncology Beaumont - USOR, Beaumont

78041

Oncology and Hematology of South Texas, Laredo

78705

Texas Oncology - Austin Midtown, Austin

78731

Texas Oncology - Austin Central, Austin

78745

Texas Oncology - South Austin, Austin

84106

Utah Cancer Specialist, Salt Lake City

84112

University of Utah - Huntsman Cancer Institute, Salt Lake City

85364

Yuma Regional Medical Center, Yuma

87131

University of New Mexico Comprehensive Cancer Center, Albuquerque

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

University of Southern California (USC), Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90095

UCLA, Los Angeles

92350

Loma Linda University Medical Center, Loma Linda

92708

Compassionate Cancer Care, Fountain Valley

92713

Providence Portland Medical Center, Portland

92835

St. Joseph Heritage Healthcare, Fullerton

92868

University of California Irvine, Chao Family Comprehensive Cancer Center, Orange

95403

St. Joseph Heritage Healthcare - Santa Rosa, Santa Rosa

96813

Hawaii Cancer Care, Honolulu

97239

Oregon Health & Science University (OHSU) Knight Cancer Institute, Portland

98109

University of Washington Seattle Cancer Care Alliance (SCCA), Seattle

98405

Northwest Medical Specialities, Tacoma

770390

Oncology Consultants, Houston

02114

Massachusetts General Hospital, Boston

03766

Dartmouth-Hitchcock Medical Center, Lebanon

07109

New Jersey Cancer Care and Blood Disorders (NJCCBD), Belleville

07932

Summit Medical Group, Berkeley Heights

07652

The Valley Hospital - Luckow Pavilion, Paramus

Sponsors
All Listed Sponsors
lead

Calithera Biosciences, Inc

INDUSTRY

NCT04265534 - KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC | Biotech Hunter | Biotech Hunter