Chemotherapy+/- MK-3475 in TKI-resistant EGFR-mutated Tumors in NSCLC
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
IRAS ID
244650
Contact name
Samreen Ahmed
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-004188-11
Duration of Study in the UK
5 years, months, days
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 87% of all lung cancers in the UK. The global incidence of lung cancer was 1.8 million in 2012, resulting in an estimated 1.6 million deaths, according to the WHO.
Recently, immune checkpoint inhibitors and anti-PD-1 (programmed death-1) and anti-PD-L1 (programmed death-ligand) antibodies showed quite promising and durable response across broad range of solid tumours including NSCLC. However, alternative treatments have been studied in clinical trials, but none of these have been approved as standard treatment, confirming an unmet medical need that exists in this patient population.
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 block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.This is a randomised, active-control with placebo, parallel-group, multi-site, double-blind study of intravenous pembrolizumab combined with pemetrexed plus platinum chemotherapy versus placebo combined with pemetrexed plus platinum chemotherapy in participants with TKI resistant EGFR-mutated tumours in metastatic non-squamous NSCLC.
Approximately 480 male/female participants aged ≥18yrs will be enrolled in this trial to examine the effectiveness of pembrolizumab combined with chemotherapy compared to chemotherapy alone. The trial will last approximately 5 years.
The study is funded by Merck Sharp & Dohme Limited and will take place at 8 study centres in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0119
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion