Trial Details 74 Total Sites

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 (PR), or complete response (CR) following completion of standard of care first-line 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).

phase

Phase 3

status

Recruiting

enrollment

650

score

52

start date

2020-10-26

last updated

2021-12-21

biomarkers

N/A

New York City, New York
facility
GSK Investigational Site
facility
GSK Investigational Site
2 facilities
Recruiting
Los Angeles, California
facility
GSK Investigational Site
1 facility
Recruiting
San Antonio, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Dallas, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Charlotte, North Carolina
facility
GSK Investigational Site
1 facility
Recruiting
Nashville, Tennessee
facility
GSK Investigational Site
1 facility
Recruiting
Sacramento, California
facility
GSK Investigational Site
1 facility
Recruiting
Atlanta, Georgia
facility
GSK Investigational Site
1 facility
Recruiting
Pittsburgh, Pennsylvania
facility
GSK Investigational Site
1 facility
Recruiting
Plano, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Worcester, Massachusetts
facility
GSK Investigational Site
1 facility
Recruiting
Chattanooga, Tennessee
facility
GSK Investigational Site
1 facility
Recruiting