A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial of Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in Participants with Advanced or Metastatic Non-small Cell Lung Cancer whose Tumors Express PD-L1 with Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

Condition studied

Advanced or Metastatic Non-Small Cell Lung Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 1b only: Number of Participants with Dose-Limiting Toxicities, Treatment-Emergent Adverse Events, and other safety parameters during the trial., Phase 2 only: Progression-Free survival by blinded independent central review (BICR).

Endpoint detail

Phase 2 only: Objective Response Rate (ORR) by BICR, Phase 2 only: Duration of Response (DoR) by BICR, Phase 2 only: Disease Control Rate (DCR) by BICR, Phase 2 only: Overall Survival (OS), Phase 2 only: Progression-Free Survival by Investigator