drugset / Trial / NCT07431827

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

NCT07431827

Phase 3 Recruiting 400 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-03-18
Primary completion
2039-10-26
Completion
2039-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Calderasib Unknown Oral
Background MK-3475A Unknown Subcutaneous