OncRef

Clinical Trial: 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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:GlaxoSmithKline
Information Provided By:GlaxoSmithKline
Last Update Posted:2026-06-18

Study Overview

Brief 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).

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

Conditions

Lung Cancer, Non-Small Cell

Intervention / Treatment

  • Drug: Niraparib
  • Biological: Pembrolizumab
  • Drug: Placebo

Other Study ID Numbers

  • 213400
  • 2023-508443-40
  • 2020-002202-20
  • 2023

Start Date (Actual)

2020-10-26

Primary Completion Date (Actual)

2025-02-26

Study Completion Date (Actual)

2026-03-23

Enrollment (Actual)

666

Study Type

Interventional

Phase

Phase 3