Clinical trialNCT04265534TerminatedPhase 2Interventional

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

SponsorCalithera Biosciences, IncEnrollment40KEAP1 Gene MutationNFE2L2 Gene MutationNRF2 Gene MutationNon-Small Cell Lung CancerNon-Squamous Non-Small Cell Neoplasm of LungNon-squamous Non-small-cell Lung Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Emil Kuriakose, MD
Calithera Biosciences, Inc
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

102 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ucla
Los Angeles, California, United States
University of Southern California (usc)
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 D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., 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)
St. 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
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Cancer Institute
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

62 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin ChemotherapyDexamethasonePembrolizumab ImmunotherapyPemetrexed ChemotherapyPlaceboTelaglenastat

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Jul 2020
Primary completion: 5 Nov 2021
Completion: 9 Feb 2022
Last update posted: 21 Sept 2022
Registered enrollment: 40
Registry id: NCT04265534

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.