NCT04265534 (KEAPSAKE) is a Phase 2 clinical trial of Telaglenastat in Non-Small Cell Lung Cancer, sponsored by Calithera Biosciences, Inc.

Who is sponsoring NCT04265534?

NCT04265534 is sponsored by Calithera Biosciences, Inc.

What drugs are being tested in NCT04265534?

Interventions in NCT04265534: Telaglenastat, Carboplatin Chemotherapy, Pemetrexed Chemotherapy, Pembrolizumab Immunotherapy, Placebo, Folic acid 400 -1000 μg, Vitamin B12 1000 μg, Dexamethasone 4 mg.

What condition does NCT04265534 study?

NCT04265534 studies Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung, KEAP1 Gene Mutation, NRF2 Gene Mutation, NFE2L2 Gene Mutation.

Is NCT04265534 still recruiting?

NCT04265534 is currently terminated. Last updated 21 September 2022.

Last reviewed 2022-09-21 · How we verify

NCT04265534: KEAPSAKE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 21 September 2022

What this trial tests

Phase 2 trial testing Telaglenastat in Non-Small Cell Lung Cancer in 40 participants. Terminated before completion.

Timeline

24 July 2020

Primary endpoint
5 November 2021

9 February 2022

Quick facts

Lead sponsor	Calithera Biosciences, Inc
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	24 July 2020
Primary completion	5 November 2021
Estimated completion	9 February 2022
Sites	102 locations across United States

Drugs / interventions tested

Telaglenastat — full drug profile →
Carboplatin Chemotherapy — full drug profile →
Pemetrexed Chemotherapy — full drug profile →
Pembrolizumab Immunotherapy
Placebo
Folic acid 400 -1000 μg
Vitamin B12 1000 μg
Dexamethasone 4 mg — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
Non-squamous Non-small-cell Lung Cancer — all drugs for Non-squamous Non-small-cell Lung Cancer →
Non-Squamous Non-Small Cell Neoplasm of Lung — all drugs for Non-Squamous Non-Small Cell Neoplasm of Lung →
KEAP1 Gene Mutation — all drugs for KEAP1 Gene Mutation →

Sponsor

Calithera Biosciences, Inc — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer or Non-squamous Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
Enhancing the Efficacy of Glutamine Metabolism Inhibitors in Cancer Therapy.
Yang WH, Qiu Y, Stamatatos O, Janowitz T, et al · · 2021 · cited 222× · PMID 34020912 · DOI 10.1016/j.trecan.2021.04.003
The KEAP1-NRF2 pathway: Targets for therapy and role in cancer.
Adinolfi S, Patinen T, Jawahar Deen A, Pitkänen S, et al · · 2023 · cited 192× · PMID 37146513 · DOI 10.1016/j.redox.2023.102726
Metabolic networks in mutant KRAS-driven tumours: tissue specificities and the microenvironment.
Kerk SA, Papagiannakopoulos T, Shah YM, Lyssiotis CA. · · 2021 · cited 182× · PMID 34244683 · DOI 10.1038/s41568-021-00375-9
NRF2: KEAPing Tumors Protected.
Pillai R, Hayashi M, Zavitsanou AM, Papagiannakopoulos T. · · 2022 · cited 151× · PMID 35101864 · DOI 10.1158/2159-8290.cd-21-0922
The Glutaminase Inhibitor CB-839 (Telaglenastat) Enhances the Antimelanoma Activity of T-Cell-Mediated Immunotherapies.
Varghese S, Pramanik S, Williams LJ, Hodges HR, et al · · 2021 · cited 132× · PMID 33361272 · DOI 10.1158/1535-7163.mct-20-0430
Targeting Metabolism in Cancer Cells and the Tumour Microenvironment for Cancer Therapy.
Li J, Eu JQ, Kong LR, Wang L, et al · · 2020 · cited 99× · PMID 33092283 · DOI 10.3390/molecules25204831
Cancer cell metabolic reprogramming: a keystone for the response to immunotherapy.
Cerezo M, Rocchi S. · · 2020 · cited 87× · PMID 33177494 · DOI 10.1038/s41419-020-03175-5

Verify or expand the search:

Other trials of Telaglenastat

Trials testing the same drug.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT04540965 — Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting

Other Calithera Biosciences, Inc trials

Trials by the same sponsor.

NCT05319028 — Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) · Phase 2 · terminated
NCT04698681 — NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial · terminated
NCT04607512 — Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects · Phase 1 · completed
NCT04540965 — Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects · Phase 1 · completed
NCT04279769 — Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04265534 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Calithera Biosciences, Inc
Last refreshed: 21 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04265534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing