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

Part of paid clinical trials in Whittier, Alaska.

Sponsor
Tesaro, Inc.
Study ID
NCT03308942
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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).
  • Pembrolizumab — BIOLOGICAL
    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
  • TSR-042 (Dostarlimab) — BIOLOGICAL
    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.

Study Details

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 Dates

First listed
Oct 13, 2017
Start date
Sep 29, 2017
Status verified
Oct 2023
Primary completion
May 4, 2020
Completion
Aug 31, 2021

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1 (Cohort 1): Niraparib plus Pembrolizumab
    Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors have high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) will receive combination of niraparib and a PD-1 inhibitor; pembrolizumab.
  • Experimental: Stage 1 (Cohort 2): Niraparib plus Pembrolizumab
    Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) will receive combination of niraparib and a PD-1 inhibitor; pembrolizumab.
  • Experimental: Stage 1 (Cohort 3): Niraparib
    Participants with locally advanced and metastatic squamous NSCLC who have been previously treated with both platinum and either PD-1 or PD-L1 inhibitor will receive single agent niraparib.
  • Experimental: Stage 2 (Cohort 1A): Niraparib plus TSR-042 (Dostarlimab)
    Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) will receive combination of niraparib and a PD-1 inhibitor; TSR-042 (Dostarlimab).
  • Experimental: Stage 2 (Cohort 2A): Niraparib plus TSR-042 (Dostarlimab)
    Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) will receive combination of niraparib and a PD-1 inhibitor; TSR-042 (Dostarlimab).

Primary Outcome Measure

Stage 1: Cohort 1: Objective Response Rate (ORR) [ Time Frame: Up to a maximum of 29 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteWhittierAlaska90603-
GSK Investigational SitePort Saint LucieFlorida34952-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteHarveyIllinois60426-
GSK Investigational SiteTinley ParkIllinois60487-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteFlorham ParkNew Jersey07932-
GSK Investigational SiteBuffaloNew York14263-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteCantonOhio44718-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteColumbusOhio31904-
GSK Investigational SiteToledoOhio43623-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteKennewickWashington99336-
GSK Investigational SiteTacomaWashington98405-

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