NCT04265534

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Telaglenastat	Oral Glutaminase Inhibitor
DRUG	Carboplatin Chemotherapy	IV infusion
DRUG	Pemetrexed Chemotherapy	IV infusion
BIOLOGICAL	Pembrolizumab Immunotherapy	IV infusion
DRUG	Placebo	Oral placebo
DIETARY_SUPPLEMENT	Folic acid 400 -1000 μg	Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.
DIETARY_SUPPLEMENT	Vitamin B12 1000 μg	Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
DRUG	Dexamethasone 4 mg	For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Timeline

• Start date: 2020-07-24
• Primary completion: 2021-11-05
• Completion: 2022-02-09
• First posted: 2020-02-11
• Last updated: 2022-09-21

Locations

102 sites across 1 country: United States

Regulatory

• FDA-regulated drug study