Chemo +/- MK-3475 as Perioperative Therapy for Resectable NSCLC
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
IRAS ID
238790
Contact name
Samreen Ahmed
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2017-001832-21
Duration of Study in the UK
7 years, 5 months, 22 days
Research summary
Lung cancer is the most common global cancer and is responsible for the majority of cancer deaths. In 2012, an estimated 1.8 million new cases of lung cancer occurred (comprising 13% of total new global cancer cases), resulting in approximately 1.5 million deaths. Due to widespread continued cigarette smoking, lung cancer will remain a significant worldwide public health problem for the foreseeable future. Non-small cell lung cancer (NSCLC) represents 80% of lung cancers, with 35% of these patients having stage II or IIIA NSCLC. Five-year survival for patients with Stages II and IIIA disease following removal of the tumour is 40% and 25%, respectively.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and 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 has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This phase III study will last approximately 6 years (1 year treatment; 5 years follow-up) and will recruit approximately 786 participants over the age of 18 with resectable Stage IIB or IIIA NSCLC.
The purpose of the study is to evaluate the safety and effectiveness of pembrolizumab given as neoadjuvant therapy along with chemotherapy, and as adjuvant therapy, versus chemotherapy plus placebo neoadjuvant therapy and placebo adjuvant therapy. Participants will be assigned randomly in a 1:1 ratio to one of the two arms of trial. Participants may receive pembrolizumab treatment for up to 1 year.The study is funded by Merck Sharp & Dohme Limited and will take place at 7 study centres in UK.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0122
Date of REC Opinion
23 Mar 2018
REC opinion
Further Information Favourable Opinion