Pure Global AI
NCT06345729Recruiting

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)

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%
Merck Sharp & Dohme LLCPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non-small Cell Lung Cancer
Drug/Device/Intervention
MK-1084
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Billings, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
May 31, 2024
End date
Feb 18, 2031
Enrollment
600 participants
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
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06345729
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.