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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.

Patient Profile

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 information


Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: MK3475-495
Number: 17-34
Full Title:

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
Type: Industry Sponsored

Merck Sharp & Dohme

Recruitment Started: Global: October 2018
Ireland: July 2019
Global Recruitment Target: 288
Ireland Recruitment Target: 8