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

Part of paid clinical trials in Fullerton, California.

Sponsor
GlaxoSmithKline
Study ID
NCT04475939
Phase
PHASE3
Status
Completed

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib will be administered.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered
  • Placebo — DRUG
    Matching placebo will be administered

Study Details

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).

Key Dates

Start date
Oct 26, 2020
Status verified
Apr 2026
Primary completion
Feb 26, 2025
Completion
Mar 23, 2026

Study Design

Enrollment
666 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving niraparib plus pembrolizumab
    Eligible participants will receive niraparib along with pembrolizumab.
  • Placebo Comparator: Participants receiving placebo plus pembrolizumab
    Eligible participants will receive matching placebo along with pembrolizumab.

Primary Outcome Measure

Progression-free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) - Complete and Partial Response (CR/PR) Population [ Time Frame: Up to 52 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteFullertonCalifornia92835-
GSK Investigational SiteLos AngelesCalifornia90017-
GSK Investigational SiteLone TreeColorado80128-
GSK Investigational SiteNorwichConnecticut06360-
GSK Investigational SiteTallahasseeFlorida32003-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteNewnanGeorgia30265-
GSK Investigational SiteNilesIllinois60714-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteWorcesterMassachusetts01655-
GSK Investigational SiteMineolaNew York10016-
GSK Investigational SiteNew YorkNew York10016-4744-
GSK Investigational SiteCharlotteNorth Carolina28207-
GSK Investigational SitePittsburghPennsylvania15212-
GSK Investigational SiteChattanoogaTennessee37404-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteDallasTexas75246-
GSK Investigational SiteSan AntonioTexas78217-
GSK Investigational SiteSugar LandTexas77479-
GSK Investigational SiteWacoTexas76712-
GSK Investigational SiteFairfaxVirginia22031-

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