Phase3 pembro+chemoradiation +/- olaparib vs chemoradiation in LS-SCLC
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
IRAS ID
288923
Contact name
Daniel Smith
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
Eudract number
2019-003616-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 10 months, 21 days
Research summary
Small cell lung cancer (SCLC) represents 15% of all lung cancers with approximately 275,000 new cases yearly, globally. Approximately 30% of patients with SCLC present with early stage disease are classified as Limited-Stage Small Cell Lung Cancer (LS-SCLC). The standard of care treatment for these patients remains concurrent chemotherapy and thoracic radiation without an agent being approved in the maintenance therapy. Median survival is 16-30 months after treatment and the 2-year survival rate is less than 50%.
Pembrolizumab is a type of immunotherapy that stimulates the body’s immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Pembrolizumab has been evaluated for treatment of SCLC in 2 multicohort studies, with encouraging findings. Equally, pembrolizumab in combination with chemotherapy has shown treatment benefit for overall survival in patients with Extensive Stage SCLC.Olaparib is a type of targeted therapy called a PARP-inhibitor. PARP is an enzyme (protein) that helps damaged cells, including cancer cells, to repair themselves. Olaparib stops the PARP enzyme from repairing damage in cancer cells and thus the cancer cells die. Olaparib is established as maintenance therapy for other cancers and therefore may provide a potential maintenance therapy for LS-SCLC where no maintenance agent is approved.
This study will evaluate safety and effectiveness of chemoradiation therapy plus pembrolizumab, followed by pembrolizumab with/without Olaparib versus chemoradiation therapy alone. Approximately 672 participants will be enrolled and randomised into study arms in a 1:1:1 ratio after a 28-day screening period. After, participants will be assigned treatment. The study will last approximately 82 months.
This study, funded by Merck Sharp & Dohme Limited, will take place at 6 study centres in the UK.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0176
Date of REC Opinion
19 Apr 2021
REC opinion
Further Information Favourable Opinion