NCT04475939

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

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/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 666 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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).

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib will be administered.
BIOLOGICAL	Pembrolizumab	Pembrolizumab will be administered
DRUG	Placebo	Matching placebo will be administered

Timeline

• Start date: 2020-10-26
• Primary completion: 2025-02-26
• Completion: 2026-03-06
• First posted: 2020-07-17
• Last updated: 2026-01-08

Locations

189 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Colombia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study