Overview

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

Status:
Active, not recruiting

Trial end date:
2022-05-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Calithera Biosciences, Inc

Treatments:

Carboplatin
Dexamethasone
Folic Acid
Hydroxocobalamin
Pembrolizumab
Pemetrexed
Vitamin B 12
Vitamin B Complex
Vitamins