Clinical Trial

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

Study acronym: KANDLELIT-013
Recruiting Phase 3
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Summary
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Protocol Amendment History 11 changes
notable Trial sites expanded: 79 -> 82 locations 2026-08-08
notable Trial sites expanded: 72 -> 79 locations 2026-08-04
notable Trial sites expanded: 69 -> 72 locations 2026-07-25
notable Trial sites expanded: 65 -> 69 locations 2026-07-21
notable Trial sites expanded: 59 -> 65 locations 2026-07-11
notable Trial sites expanded: 49 -> 56 locations 2026-06-19
notable Trial sites expanded: 36 -> 49 locations 2026-06-13
notable Trial sites expanded: 24 -> 36 locations 2026-06-04
notable Trial sites expanded: 17 -> 24 locations 2026-05-12
notable Trial sites expanded: 1 -> 14 locations 2026-04-21
critical Recruitment opened 2026-04-02
Trial Details
NCT Number NCT07431827
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 400 participants
Start Date 2026-03-18
Primary Completion 2039-10-26 (estimated)
Study Completion 2039-10-26 (estimated)
Updated on ClinicalTrials.gov 2026-08-13