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

Brief description of study

The purpose of the study is to evaluate niraparib plus pembrolizumab versus placebo plus pembrolizumab in participants with advanced or metastatic nonsmall cell lung cancer (NSCLC) who have stable disease (SD), partial response (PR), or complete response (CR) following completion of platinum-based first-line induction chemotherapy with pembrolizumab. The study drug niraparib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s20-00755
ClinicalTrials.gov Identifier: NCT04475939

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.