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

Official Title

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Summary:

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 tumour 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.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1)

Secondary Outcome:

• Progression Free Survival (PFS) per RECIST 1.1
• Overall Survival (OS)
• Number of Participants Experiencing Adverse Events (AEs)
• Number of Participants Discontinuing Study Drug Due to AEs

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

View this trial on ClinicalTrials.gov