A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004) - Trial NCT06345729
Access comprehensive clinical trial information for NCT06345729 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Non-small Cell Lung Cancer. Target enrollment is 600 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
May 31, 2024
Feb 18, 2031
Primary Outcome
Progression-Free Survival (PFS),Overall Survival (OS)
Summary
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as
 first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with
 identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and
 programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two
 primary study hypotheses:
 
 Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus
 pembrolizumab with respect to progression free survival (PFS) per Response Evaluation
 Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review
 (BICR).
 
 Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus
 pembrolizumab with respect to overall survival (OS).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06345729
Non-Device Trial