Actively Recruiting
Phase 3 Study of Adjuvant Calderasib with Subcutaneous Pembrolizumab and Berahyaluronidase Alfa Versus Placebo in Completely Removed Stage IIA-IIIB KRAS G12C-mutant Non-Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
Led by Merck Sharp & Dohme LLC · Updated on 2026-08-07
400
Participants Needed
82
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of adjuvant calderasib combined with subcutaneous pembrolizumab and berahyaluronidase alfa MK-3475A compared to placebo plus MK-3475A in participants with completely resected stage IIA-IIIB N2, KRAS G12C-mutant non-small cell lung cancer. This phase 3, randomized, double-blind study focuses on participants who have received either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy, aiming to improve disease-free survival. Participants are randomly assigned to receive either calderasib daily along with MK-3475A every 6 weeks for up to 9 doses, or placebo daily plus MK-3475A on the same schedule. The study compares these two groups to assess their effects on disease progression. The treatment period involves regular dosing and monitoring over time. During the study, participants will be monitored for disease-free survival for up to approximately 11 years. Researchers will also assess overall survival, distant metastasis-free survival, lung cancer-specific survival, and changes in quality of life using validated questionnaires. Safety will be checked through reports of adverse events and treatment discontinuations over an extended follow-up period of up to about 13.5 years.
CONDITIONS
Brief Title
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Research Team
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