ClinicalTrials.gov record
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC
ClinicalTrials.gov ID: NCT04265534
Public ClinicalTrials.gov record NCT04265534. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04265534
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- Telaglenastat Drug
- Carboplatin Chemotherapy Drug
- Pemetrexed Chemotherapy Drug
- Pembrolizumab Immunotherapy Biological
- Placebo Drug
- Folic acid 400 -1000 μg Dietary Supplement
- Vitamin B12 1000 μg Dietary Supplement
- Dexamethasone 4 mg Drug
Drug · Biological · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2020 (Actual)
- Primary completion
- Nov 5, 2021 (Actual)
- Completion
- Feb 9, 2022 (Actual)
- Last update posted
- Sep 21, 2022
2020 – 2022
United States locations
- U.S. sites
- 102
- U.S. states
- 34
- U.S. cities
- 89
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of South Alabama - Mitchell Cancer Center | Mobile | Alabama | 36604 | — |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | — |
| Compassionate Cancer Care | Fountain Valley | California | 92708 | — |
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92350 | — |
| University of Southern California (USC) | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| UCLA | Los Angeles | California | 90095 | — |
| University of California Irvine, Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| St. Joseph Heritage Healthcare - Santa Rosa | Santa Rosa | California | 95403 | — |
| Johns Hopkins Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Boca Raton Regional Hospital Lynn Cancer Institute | Boca Raton | Florida | 33486 | — |
| Holy Cross Hospital - Bines Cancer Center | Fort Lauderdale | Florida | 33308 | — |
| Florida Cancer Specialist - South (SCRI) | Fort Myers | Florida | 33901 | — |
| Memorial Cancer Institute at Memorial Hospital West | Hollywood | Florida | 33021 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Ocala Oncology Center | Ocala | Florida | 34474 | — |
| Florida Cancer Specialist - North (SCRI) | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialist - Panhandle (SCRI) | Tallahassee | Florida | 32308 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Florida Cancer Specialist - East (SCRI) | West Palm Beach | Florida | 33401 | — |
| University Cancer and Blood Center | Athens | Georgia | 30607 | — |
| Piedmont Cancer Institute | Atlanta | Georgia | 30318 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Northwest Georgia Oncology | Marietta | Georgia | 30060 | — |
| Hawaii Cancer Care | Honolulu | Hawaii | 96813 | — |
| Oncology of Northshore | Rolling Meadows | Illinois | 60008 | — |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | — |
| Beacon Health | South Bend | Indiana | 46601 | — |
| University of Kansas Medical Center (KUMC) | Westwood | Kansas | 66205 | — |
| Pontchartrain Cancer Center | Covington | Louisiana | 70443 | — |
| Johns Hopkins Bayview Memorial Hospital | Baltimore | Maryland | 21224 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Maryland Oncology Hematology - USOR | Columbia | Maryland | 21044 | — |
| Frederick Health - James M. Stockman Cancer Institute | Frederick | Maryland | 21702 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Cancer Institute | Detroit | Michigan | 48202 | — |
| Bronson Methodist Hospital (West Michigan Cancer Center) | Kalamazoo | Michigan | 49001 | — |
| St. Joseph Mercy Hospital Cancer Care Center | Ypsilanti | Michigan | 48197 | — |
| Minnesota Oncology Hematology, P.A. | Coon Rapids | Minnesota | 55433 | — |
| Minnesota Oncology Hematology, P.A. | Edina | Minnesota | 55435 | — |
| Minnesota Oncology Hematology, P.A. | Maplewood | Minnesota | 55109 | — |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | — |
| Minnesota Oncology Hematology, P.A. | Saint Paul | Minnesota | 55102 | — |
| Minnesota Oncology Hematology, P.A. | Woodbury | Minnesota | 55125 | — |
| Central Care Cancer Center | Bolivar | Missouri | 65613 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| New Jersey Cancer Care and Blood Disorders (NJCCBD) | Belleville | New Jersey | 07109 | — |
| Summit Medical Group | Berkeley Heights | New Jersey | 07932 | — |
| The Valley Hospital - Luckow Pavilion | Paramus | New Jersey | 07652 | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.) | Albany | New York | 12206 | — |
| New York Oncology Hematology, P.C. (43 New Scotland Ave.) | Albany | New York | 12208 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| New York Oncology Hematology, P.C. | Clifton Park | New York | 12065 | — |
| Pelmutter Cancer Center at Winthrop | Mineola | New York | 11501 | — |
| New York University Langone (NYU) | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10065 | — |
| Cone Health at Alamance Regional | Burlington | North Carolina | 27215 | — |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| TriHealth Cancer Institute | Cincinnati | Ohio | 45220 | — |
| Ohio State University, James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | — |
| Ohio Health | Columbus | Ohio | 43214 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Oklahoma Cancer Specialists and Research Institute (OCSRI) | Tulsa | Oklahoma | 74146 | — |
| Providence Portland Medical Center | Portland | Oregon | 92713 | — |
| Oregon Health & Science University (OHSU) Knight Cancer Institute | Portland | Oregon | 97239 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Pennsylvania State University Milton S. Hershey Medical Center | State College | Pennsylvania | 16801 | — |
| Sanford Health | Sioux Falls | South Dakota | 57104 | — |
| Tennessee Oncology - Chattanooga (SCRI) | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology - Nashville (SCRI) | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology - Austin Central | Austin | Texas | 78731 | — |
| Texas Oncology - South Austin | Austin | Texas | 78745 | — |
| Texas Oncology Beaumont - USOR | Beaumont | Texas | 77701 | — |
| Texas Oncology - Denison | Denison | Texas | 75020 | — |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | — |
| Oncology Consultants | Houston | Texas | 770390 | — |
| Oncology and Hematology of South Texas | Laredo | Texas | 78041 | — |
| Utah Cancer Specialist | Salt Lake City | Utah | 84106 | — |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Oncology and Hematology Associates of Southwest Virginia | Blacksburg | Virginia | 24060 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Oncology and Hematology Associates of Southwest Virginia | Low Moor | Virginia | 24457 | — |
| Virginia Commonwealth University (VCU) Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | — |
| Oncology and Hematology Associates of Southwest Virginia | Salem | Virginia | 24153 | — |
| Oncology and Hematology Associates of Southwest Virginia | Wytheville | Virginia | 24382 | — |
| University of Washington Seattle Cancer Care Alliance (SCCA) | Seattle | Washington | 98109 | — |
| Northwest Medical Specialities | Tacoma | Washington | 98405 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | — |
| Froedtert Hospital and the Medical College of Wisconsin (MCW) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04265534, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04265534 live on ClinicalTrials.gov.