Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04265534
Status:
TERMINATED
Last Update Posted:
2022-09-21
First Post:
2020-02-07
Brief Title:
KEAPSAKE A Study of Telaglenastat CB-839 With Standard-of-Care Chemoimmunotherapy in 1L KEAP1NRF2-Mutated Nonsquamous NSCLC
Sponsor:
Calithera Biosciences Inc
Organization:
Calithera Biosciences Inc
Study Overview
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 KEAP1NRF2-Mutated Nonsquamous Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Clinical Benefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KEAPSAKE
Brief 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 KEAP1NRF2-mutated stage IV nonsquamous non-small cell lung cancer NSCLC The study primary endpoints are PFS per RECIST v 11 and safety KEAP1NRF2 mutation status for eligibility and STK11LKB1 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None