Pembrolizumab with or without olaparib in metastatic squamous NSCLC
Research type
Research Study
Full title
A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
IRAS ID
264788
Contact name
Shobhit Baijal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Eudract number
2018-004721-88
Duration of Study in the UK
4 years, 10 months, 1 days
Research summary
Squamous Non-Small-Cell Lung Cancer (NSCLC) accounts for approximately 30% to 35% of all NSCLC, with the majority of patients having advanced inoperable disease at diagnosis. Platinum-based chemotherapy was the standard of care in the first-line treatment in this disease until recently when immunotherapy has begun to change outcomes in this patient population. There is currently no approved maintenance therapy (therapy to prevent cancer from returning) for this disease.
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 shown increases in overall survival of patients with NSCLC and is approved for treatment of NSCLC under certain conditions. Despite this, patients with squamous NSCLC continue to experience disease progression, and therefore new treatments are needed.
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 already approved as maintenance therapy for other cancers and therefore may provide a potential treatment option for squamous NSCLC.
This study will compare the safety and effectiveness of pembrolizumab + olaparib versus pembrolizumab + placebo. Approximately 735 participants will be enrolled into a 12-week Induction Phase to receive pembrolizumab, carboplatin and taxane (paclitaxel or nab-paclitaxel). Following this, approximately 566 participants will be randomised in a 1:1 ratio into the Maintenance Phase to receive pembrolizumab with either olaparib or a placebo for approximately 2 years.
The study is funded by Merck Sharp & Dohme Limited and will take place at 10 study centres in the UK.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0189
Date of REC Opinion
8 Jul 2019
REC opinion
Further Information Favourable Opinion