Science and Research

A phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab vs 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/IIIC or IV non-small cell lung cancer (ZEAL-1L)

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 (SoC 1L) 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).

Study details
Study-ID: NCT04475939, 2020-002202-20
Study-ID: NCT04475939, 2020-002202-20
DZL Disease Area: LC
DZL Disease Area: LC
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL recruiting center
DZL Role: DZL recruiting center
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: ARCN, CPC-M
DZL Participating Sites: ARCN, CPC-M
Start Date: 26.10.2020
Completion Date: 06.03.2026
Status: Active / not recruiting
Status: Active / not recruiting
DZL recruiting center
Link to Study


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