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NCT04475939 · ClinicalTrials.gov registry record · Phase 3
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 study of Lung Cancer, Non-Small Cell, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 666
- Enrollment target
- 20
- Study locations
NCT04475939 is a Phase 3 study of Lung Cancer, Non-Small Cell that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 666 participants, above the 265-participant average among 10 other Lung Cancer, Non-Small Cell trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT04475939, a Phase 3 study of Lung Cancer, Non-Small Cell, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 666 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Niraparib
Study Locations (20)
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - San Antonio
- GSK Investigational Site - Sherman
- GSK Investigational Site - Sugar Land
California
- GSK Investigational Site - Fullerton
- GSK Investigational Site - Los Angeles
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Newnan
New York
- GSK Investigational Site - Mineola
- GSK Investigational Site - New York
Tennessee
- GSK Investigational Site - Chattanooga
- GSK Investigational Site - Nashville
Colorado
- GSK Investigational Site - Lone Tree
Connecticut
- GSK Investigational Site - Norwich
Florida
- GSK Investigational Site - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04475939
The ClinicalTrials.gov registry entry for NCT04475939 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 265-participant average among 10 other Lung Cancer, Non-Small Cell trials with a reported enrollment target (151% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lung Cancer, Non-Small Cell appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04475939 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04475939 about?
NCT04475939 is a clinical study titled "Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer". 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 (P...
What is the current status of trial NCT04475939?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2020-10-26. Estimated completion is 2026-03-06.
What conditions does trial NCT04475939 study?
This clinical trial studies the following conditions: Lung Cancer, Non-Small Cell.
What interventions are being tested in trial NCT04475939?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT04475939?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04475939 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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