A Phase II Study of Telaglenastat in Combination with Pembrolizumab Immunotherapy, Carboplatin, and Pemetrexed in People with Non-Small Cell Lung Cancer

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Full 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 KEAP1/NRF2-Mutated, Non-Squamous, Non-Small Cell Lung Cancer (NSCLC) (KEAPSAKE Protocol Number: CX-839-014)

Purpose

Metastatic non-small cell lung cancer (NSCLC) that has a mutation in the KEAP1 or NRF2 gene usually does not respond well to standard treatment with immunotherapy and chemotherapy (the drugs pembrolizumab, carboplatin, and pemetrexed). In this study, researchers are assessing the safety and effectiveness of adding the investigational drug telaglenastat to standard chemotherapy and immunotherapy in these patients. Telaglenastat is designed to block the activity of an enzyme called glutaminase, which can cause cancer cells to grow. Investigators want to see if it increases the effectiveness of the standard treatment.

Participants in this study will be randomly assigned to receive pembrolizumab, carboplatin, and pemetrexed with either telaglenastat or a placebo. Telaglenastat is taken orally (by mouth) and the other drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have previously untreated nonsquamous metastatic NSCLC that has a mutation in the KEAP1 or NRF2 gene.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Paik at 646-608-3759.

Protocol

21-358

Phase

II

Investigator

Co-Investigators