Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Completed · Phase 2

Conditions studied: Neoplasms

In brief

This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer (NSCLC). The study will consist of 2 stages. In stage 1, participants from Cohorts 1 and 2 will receive niraparib plus PD-1 inhibitor; pembrolizumab and participants from Cohort 3 will receive niraparib alone. In Stage 2, participants from Cohorts 1A and 2A will receive niraparib plus the PD-1 inhibitor, TSR-042 (Dostarlimab).

Key facts

Study ID

NCT03308942

Run by

Tesaro, Inc.

People needed

53

Starts

2017-09-29

Expected to finish

2021-08-31

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Whittier, Alaska, United States
• GSK Investigational Site — Port Saint Lucie, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Harvey, Illinois, United States
• GSK Investigational Site — Tinley Park, Illinois, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Florham Park, New Jersey, United States
• GSK Investigational Site — Buffalo, New York, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Canton, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Toledo, Ohio, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Kennewick, Washington, United States
• GSK Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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