Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Active:	No
Cancer Type:	Lung Cancer	NCT ID:	NCT04475939
Trial Phases:	Phase III	Protocol IDs:	213400 (primary) NCI-2020-11424
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	GlaxoSmithKline
NCI Full Details:	http://clinicaltrials.gov/show/NCT04475939

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus
pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with
advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease
(SD), partial response (PR), or complete response (CR) following completion of standard of
care first-line platinum-based induction chemotherapy with pembrolizumab. The primary
hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib
plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free
survival (PFS) and Overall survival (OS).

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