SBRT ± Pembrolizumab in patients with Unresected Stage I or II NSCLC
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
IRAS ID
263894
Contact name
Fabricio Souza
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-004320-11
Duration of Study in the UK
6 years, 8 months, 0 days
Research summary
This study is trying to find out if a research study drug, pembrolizumab (also known as MK-3475) combined with Stereotactic Body Radiation Therapy (SBRT), also called Stereotactic Ablative Body Radiotherapy (SABR), is safe and works to help slow down the re-growth of Non-Small Cell Lung Cancer in patients who are unable to have surgery due to other medical issues and have received no prior anti-cancer therapy for their present lung cancer.
Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. SBRT is a type of radiation therapy which uses high doses of radiation over a short period of time to kill tumour cells and shrink tumours. The combination of pembrolizumab and SBRT is investigational.
This study will be recruiting internationally for 530 participants and is estimated to complete after 7 years. There are certain criteria that all participants must meet to join the study.
Eligible participants will have an equal (50/50) chance of being placed into one of the following groups:
Group A: SBRT and pembrolizumab
Group B: SBRT and placebo (no active drug)SBRT will be given over no more than 2 weeks. Pembrolizumab or placebo will be given every 3 weeks for 17 cycles (approximately for one year).
Participants will need to visit the hospital more often than normal (typically every 3 weeks) and will have procedures such as blood tests, physical examinations, CT or MRI scans.
It cannot be guaranteed that participants in clinical studies will directly benefit from treatment during participation, as clinical studies are designed to provide information about the safety and effectiveness of an investigational medicine.
The study is sponsored by Merck Sharp & Dohme Limited (MSD), and will take place at 10 study centres in UK.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1024
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion