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NCT04265534 · ClinicalTrials.gov registry record · Phase 2
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC
A Phase 2 study, sponsored by Calithera Biosciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04265534 is a Phase 2 study that was terminated before completion, run by Calithera Biosciences. The registered enrollment target is 40 participants.
The verdict
NCT04265534, a Phase 2 study, was terminated before completion, sponsored by Calithera Biosciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Telaglenastat
- DRUG Carboplatin Chemotherapy
- DRUG Pemetrexed Chemotherapy
- BIOLOGICAL Pembrolizumab Immunotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-24 |
| Est. Completion | 2022-02-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04265534
The ClinicalTrials.gov registry entry for NCT04265534 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04265534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04265534 about?
NCT04265534 is a clinical study titled "KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC". 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/NRF...
What is the current status of trial NCT04265534?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-07-24. Estimated completion is 2022-02-09.
What interventions are being tested in trial NCT04265534?
The interventions under investigation include: Placebo (DRUG), Telaglenastat (DRUG), Carboplatin Chemotherapy (DRUG), Pemetrexed Chemotherapy (DRUG), Pembrolizumab Immunotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT04265534?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
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