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)
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.
The study objectives and endpoints were designed to determine the benefit of telaglenastat in combination with pembrolizumab plus chemotherapy compared with placebo in combination with pembrolizumab plus chemotherapy as first-line treatment of patients with metastatic KEAP1- or NRF2-mutated nonsquamous Stage IV NSCLC.
Chemotherapy (NOS); Immunotherapy; Therapy (NOS)
Alimta (Pemetrexed); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Telaglenastat/Placebo (); carboplatin ()
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