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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: Active Phase 3 study of Lung Cancer, Non-Small Cell, sponsored by GlaxoSmithKline.
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 414-participant average among 16 other Lung Cancer, Non-Small Cell trials with a reported enrollment target (61% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS is defined as the time from the date of randomization to the date of first objectively documented disease progression (PD) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the basel
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 |
What the registry record for NCT04475939 still lists
NCT04475939 is an interventional study that assigns participants to a tested intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap, above the 414-participant average among 16 other Lung Cancer, Non-Small Cell trials with a reported enrollment target (61% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT04475939's enrollment target sits among peer trials
666 4th of 16 higher than 13 of 16 other Lung Cancer, Non-Small Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer, Non-Small Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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