Trial Identifiers
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Scientific Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB or IV Non-Small Cell Lung Cancer
Commercial Sponsor
GlaxoSmithKline
Summary
Eligible patients will be randomised to receive 200mg of intravenous (IV) pembrolizumab over 30 minutes on Day 1 of each 21-day treatment cycle, in addition to a continuous, oral dose of Niraparib or Niraparib-placebo throughout the 21-day cycle starting on Cycle 1 (Day 1).