213400 Niraparib in Stage IIIB/IV NSCLC
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB or IV Non-Small Cell Lung Cancer
IRAS ID
287023
Contact name
Meenali Chitnis
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2020-002202-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 22 days
Research summary
Niraparib (GSK3985771) is a therapy being developed for the treatment of non-small cell lung cancer (NSCLC), the most common type of lung cancer. Niraparib is approved in the UK for the treatment of some types of Ovarian cancer. The purpose of this study is to determine whether Niraparib is effective in treating NSCLC.
Niraparib is a PARP (Poly (ADP-ribose) polymerase) inhibitor. PARP is a protein that helps all cells repair damaged DNA (DeoxyriboNucleic Acid). Cancer cells rely on PARP proteins to keep their DNA healthy, to continue growing and dividing. Niraparib stops the PARP protein from working, so the cancer cells die.
Approximately 650 patients will be enrolled in the study globally, with 15 patients recruited from UK hospitals.
The study has 3 parts: Screening, Treatment and Follow up.
Screening: If the cancer has shrunk or stopped growing following standard of care first line treatment, the patient will undergo several tests to check whether they are suitable for the study.
Treatment: Patients are assigned to treatment randomly. Half of the study-enrolled patients will receive Niraparib alongside an approved treatment called Pembrolizumab, the other half will receive placebo alongside Pembrolizumab. Neither the patient nor study doctors will know what treatment the patients are receiving.
Pembrolizumab will be given as an infusion on Day 1 of each 21-day treatment cycle. Niraparib/placebo will be given as a tablet once daily throughout each treatment cycle.
Follow-up: Once criteria for discontinuation of treatment is reached an end of trial visit is scheduled followed by safety follow up visits at 30 and 90 days after last dose. Survival follow up will continue every 90 days after last dose.
Tests undertaken will include but are not limited to blood tests, imaging (CT /MRI) Scans, vital signs, medical history review and questionnaires.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0394
Date of REC Opinion
7 Dec 2020
REC opinion
Further Information Favourable Opinion