About this trial
This trial will investigate the utility of biomarker-based triage for participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.
Patients with advanced non-small cell lung cancer (NSCLC) who are at least 18 years of age.
Where’s this trial being run?St James’s Hospital and University Hospital Limerick
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
Why not Print this page and bring it with you. It will help your doctor and research team advise you.Print this page
For more detailed informationClick Here
A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495)
|Principal Investigator:||Linda Coate|
Merck Sharp & Dohme
Global: October 2018
Ireland: July 2019
|Global Recruitment Target:||288|
|Ireland Recruitment Target:||8|