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.
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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|