Phase 2 Trial of MK-3475 + Chemo and Radiotherapy in Stage III NSCLC
Research type
Research Study
Full title
A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)
IRAS ID
248946
Contact name
Petra Jankowska
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-000714-37
Duration of Study in the UK
2 years, 2 months, 2 days
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 80% of all lung cancers and one-third of these patients will present with Stage III disease at the time of initial diagnosis. The global incidence of lung cancer according to the WHO was estimated to be 1.8 million in 2012, resulting in approximately 1.6 million deaths.
The current standard of care for Stage III NSCLC is platinum-based doublet chemotherapy concurrent with radiotherapy (cCTRT). However, the progression-free survival rate among patients receiving cCTRT is poor and there is still a significant unmet medical need for additional treatment options for use in this patient population to improve treatment results. Recently, immune checkpoint inhibitors, including pembrolizumab, have shown a promising and durable response across broad range of solid tumours including NSCLC.Pembrolizumab (MK-3475) is a potent and highly selective monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including cancer cells) that targets and blocks PD-1 on the surface of certain immune cells called T-cells, which fight cancer. Blocking PD-1 triggers the T-cells to find and kill cancer cells. The study drug, pembrolizumab has been developed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2), thereby increasing the immune attack on cancers.
This is a nonrandomised, multi-site, open-label phase 2 study of pembrolizumab in combination with cCTRT in participants with Stage III NSCLC.
Approximately 216 male/female participants aged ≥18yrs will be enrolled for approximately 29 months to examine the safety and effectiveness of pembrolizumab when combined with chemotherapy and radiotherapy.
The study is sponsored by Merck Sharp & Dohme Limited and will take place at 6 study centres in the UK.
Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03631784%253Fcond%253DKEYNOTE-799%2526rank%253D1%2526tab%253Dresults%2523results-overview%2FNBTI%2FOpy4AQ%2FAQ%2Fa0f10359-127d-48e5-86a7-0ffd983938d9%2F1%2FpOt69nKB8c%23results-overview&data=05%7C02%7Criverside.rec%40hra.nhs.uk%7C19db3ed8a73142d5a7c008dcea0cee73%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638642588475173016%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=44IIjnKGL8k2mTw6%2BcJzDj0Lo4mOBT7m2Ded3JD24XM%3D&reserved=0
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1558
Date of REC Opinion
31 Oct 2018
REC opinion
Further Information Favourable Opinion