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

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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