Clinical Trial

A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or 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 calderasib 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 calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Protocol Amendment History 2 changes
notable Trial sites expanded: 222 -> 225 locations 2026-06-09
notable Trial sites expanded: 216 -> 219 locations 2026-05-12
Trial Details
NCT Number NCT06345729
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 600 participants
Start Date 2024-05-24
Primary Completion 2029-02-19 (estimated)
Study Completion 2031-02-18 (estimated)
Updated on ClinicalTrials.gov 2026-06-15