Phase 2 Study of Pembrolizumab/Epacadostat/Chemotherapy in NSCLC
Research type
Research Study
Full title
A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer
IRAS ID
230570
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-001810-27
Duration of Study in the UK
4 years, 7 months, 8 days
Research summary
Non-small cell lung cancer (NSCLC) represents approximately 80-85% of all lung cancers. At the time of diagnosis, approximately 70% of patients have inoperable advanced disease and the 5-year relative survival for patients with spreading (metastatic) lung cancer is 4.3%.
The standard of care for metastatic NSCLC has changed with the development of immunotherapy agents but there remains a need to investigate new treatments to offer added benefit for this patient population.
Programmed cell death 1 (PD1) is a receptor protein present on the surface of immune cells (T-cells), which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) proteins on the surface of cancer cells. Interaction between these ligands and the receptors prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been designed to block PD1/PDL1 interaction to increase the immune attack on cancer cells.
Indoleamine 2,3 dioxygenase-1 (IDO1) is an enzyme found in cells. IDO1 inhibits T-cell mediated immune responses and it has been shown IDO1 expression is elevated in many cancers. Epacadostat is a novel, potent, selective inhibitor of IDO1 in cancer cells and may restore an effective antitumour immune response if used.
It is proposed that combination of pembrolizumab and epacadostat with chemotherapy may further advance treatment for the NSCLC population and could support the use of combination(s) in patients with previously untreated metastatic NSCLC.
Approximately 1062 male/female participants (≥18 years) will be enrolled in this randomised Phase III study which will last approximately 5 years. The purpose of the study is to evaluate the safety, tolerability and effectiveness of pembrolizumab, epacadostat and chemotherapy in combination.
The study is co-funded by MSD and Incyte and will take place at 8 study centres in the UK and Scotland.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0387
Date of REC Opinion
22 Nov 2017
REC opinion
Further Information Favourable Opinion