Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
NCT04475939 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04475939 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04475939?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Niraparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04475939?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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