Last updated on March 2020

A Study of Biomarker-Directed Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

Brief description of study

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study 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-1308, MK-4280, or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-1308, 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.

Detailed Study Description

After Amendment 5, participants can receive 800 mg of MK-4280 every 3 weeks (Q3W)

Clinical Study Identifier: NCT03516981

Find a site near you

Start Over

Mayo Clinic Florida ( Site 0115)

Jacksonville, FL United States
  Connect »

MPOC ( Site 2310)

Groenkloof Pretoria, South Africa
  Connect »

Wits Clinical Research ( Site 2313)

Parktown-Johannesburg, South Africa
  Connect »