Clinical trial details

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

Identifier

213400

Sponsor

GLAXOSMITHKLINE, SA

Principal Investigator

ENRIQUETA FELIP FONT

Service

Oncology

Study details

Tumor type: LUNG-NSCLC
Stage: Advanced
Main Investigational Agent : Targeted therapy
Phase: III
Randomization: Randomized

Molecular details

Biomarker: ALK wt; EGFR wt
Biomarker criteria: Mandatory
Prescreening: Local/Central
Additional study population requirements: Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed).

Drug details

Arm A: Niraparib and Pembrolizumab
Arm B: Placebo and Pembrolizumab

Links

Clinical Trials GOV (NCT identifier): NCT04475939
EU Clinical Trials Register (eudraCT Identifier): 2020-002202-20