Phase III study of Pembrolizumab in metastatic non-squamous NSCLC
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).
IRAS ID
193632
Contact name
Harry Raftopoulos
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-003694-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 26 days
Research summary
Summary of Research\nLung cancer accounted for an estimated 13% of total cancer diagnoses. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, with most being non-squamous (cancer which does not originate from a type of cell called squamous).\n\nProgress has been made in the clinical management of early stage NSCLC by establishing comprehensive, multi-modality treatment regimens; however, the prognosis for advanced disease hasn’t improved substantially and treatment of NSCLC remains a highly unmet medical need. \n\nProgrammed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligand 1 (PDL1) and programmed cell death ligand 2 (PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug Pembrolizumab is a potent & highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.\n\nApproximately 570 male/ female subjects over the age of 18 with advanced or metastatic (cancer which has spread to other parts of the body) non-squamous NSCLC will be enrolled into this Phase III study. It will last approximately 4 years and take place in 7 sites across the UK. The purpose of this study is to examine the progression free survival (PFS) of pembrolizumab compared to a placebo in combination with chemotherapy for the treatment of advanced or metastatic NSCLC.\n\nSubjects will be randomly entered into 1 of 2 groups receiving either pembrolizumab or a placebo on a backbone of chemotherapy to examine the effectiveness of pembrolizumab in improving PFS. They will receive approximately 35 treatment administrations via 3 week dosing cycles.\n\nThe study is funded by Merck Sharp & Dohme Limited.\n\nSummary of Results\nhttps://clinicaltrials.gov/study/NCT02578680?term=3475-189&limit=10&rank=1&a=54
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0022
Date of REC Opinion
12 Feb 2016
REC opinion
Further Information Favourable Opinion