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

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

September 29, 2017

Primary Completion Date

May 4, 2020

Study Completion Date

August 31, 2021

Conditions
Neoplasms
Interventions
DRUG

Niraparib

Niraparib is an orally available, potent, highly selective poly adenosine diphosphate- ribose (poly ADP-ribose) polymerase-1 (PARP-1) and PARP-2 inhibitor. It will be available as 100 milligrams (mg) capsules and will be administered as 2 X 100 mg capsules (200 mg per day) orally once daily (QD).

BIOLOGICAL

Pembrolizumab

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G-4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands (PD-L1 and PD-L2). It will be available as 50 mg lyophilized powder single-use vials or 100 mg/4 milliliters (mL) (25 mg/mL) solution in a single-dose vial. It will be administered at a dose of 200 mg intravenous (IV) using a 30-minute IV infusion

BIOLOGICAL

TSR-042 (Dostarlimab)

TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. It will be administered at a dose of 500 mg for every 3 weeks (Q3W) for first 4 cycles followed by 1000 mg for every 6 weeks (Q6W) for all subsequent cycles using a 30-minute IV infusion. TSR-042 (dostarlimab) will be supplied as a solution of 160 mg (20 mg/mL) or 500 mg (50 mg/mL) in a single-dose vial.

Trial Locations (16)

14263

GSK Investigational Site, Buffalo

27710

GSK Investigational Site, Durham

30322

GSK Investigational Site, Atlanta

31904

GSK Investigational Site, Columbus

34952

GSK Investigational Site, Port Saint Lucie

37203

GSK Investigational Site, Nashville

43623

GSK Investigational Site, Toledo

44106

GSK Investigational Site, Cleveland

44718

GSK Investigational Site, Canton

60426

GSK Investigational Site, Harvey

60487

GSK Investigational Site, Tinley Park

90603

GSK Investigational Site, Whittier

98405

GSK Investigational Site, Tacoma

99336

GSK Investigational Site, Kennewick

02215

GSK Investigational Site, Boston

07932

GSK Investigational Site, Florham Park

All Listed Sponsors
lead

Tesaro, Inc.

INDUSTRY

NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants | Biotech Hunter | Biotech Hunter