Pembrolizumab + Olaparib 1L treatment of Metastatic Nonsquamous NSCL
Research type
Research Study
Full title
A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer
IRAS ID
263695
Contact name
Shobhit Baijal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-004720-11
Duration of Study in the UK
4 years, 11 months, 27 days
Research summary
Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) accounts for approximately 65%-70% of all NSCLC, with the majority of patients having advanced inoperable disease at diagnosis. As such, additional treatment options are needed. A potential opportunity to improve upon the current standard of care of nonsquamous NSCLC is the addition of the PARP-inhibitor Olaparib, to pembrolizumab.
Pembrolizumab, in combination with pemetrexed and platinum chemotherapies, is currently approved for the first-line treatment of metastatic nonsquamous NSCLC. Olaparib is approved for treating various cancers but not NSCLC.
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.
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.
This study will compare the safety and effectiveness of pembrolizumab taken with olaparib to pembrolizumab taken with a standard chemotherapy, pemetrexed. Approximately 792 participants will be enrolled into an Induction Phase (approximately 12 weeks) of treatment with pembrolizumab, pemetrexed and platinum chemotherapy (either carboplatin or cisplatin). Following this, approximately 618 participants will be required for randomisation into the Maintenance Phase. Participants will be randomly assigned in 1:1 ratio to treatment (for approximately 2 years) with either pembrolizumab and olaparib or pembrolizumab and pemetrexed. Olaparib or pemetrexed may be continued until specific discontinuation criteria is met. Participants may also receive an additional year of pembrolizumab if eligible.
The study is funded by Merck Sharp and Dohme Limited and will take place at 8 study centres in UK.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0773
Date of REC Opinion
5 Aug 2019
REC opinion
Further Information Favourable Opinion