drugset / Trial / NCT06077760

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

NCT06077760

Phase 3 Recruiting 868 enrolled Merck Sharp & Dohme LLC ModernaTX, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Timeline

Start
2023-12-06
Primary completion
2030-06-25
Completion
2035-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Intismeran autogene Messenger RNA (mRNA) 1 mg Intramuscular
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous