KEAPSAKE

Name of study: 
A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat with Pembro and CTX Versus Placebo with Pembro and CTX in 1L, Metastatic KEAP1/NRF2-Mutated, Nonsquamous NSCLC

Targeted disease: 
Lung Cancer

Purpose of study:
This is a randomized Phase 2 study that will test whether the investigational study drug called telaglenastat will be safe and potentially effective when combined with the FDA approved immunochemotherapy regimen of pembrolizumab, carboplatin, and pemetrexed in treating patients with stage IV lung cancer that has a mutation in NRF2/(NFE2L2) or KEAP1 genes.  Patients on this study will not have received any systemic treatment for advanced lung cancer. All patients in this study will receive the approved recommended treatment regimen of pembrolizumab, carboplatin, and pemetrexed either with or without telaglenastat.

Is this a pre- or post- market study?: 
Pre-Market Study

Is the study of a controlled or observational design? 
Controlled

What is the funding source?: 
Calithera Biosciences

Where is the study being conducted?
Multi-Center Trial

Lead Institution:
Multiple Sites located in the U.S.

City and State: 
Nationwide

When the study is being conducted: 
Start Date: 2/1/2020
End date:10/30/2024

What website should a person use to register for the study?
None - Advise to speak to your physician regarding this trial

Who should a person contact to register for the study?
Clinical Administrator

Who is sponsoring this study?
Calithera Biosciences

What is the identifier for this study on ClinicalTrials.gov?
NCT04265534