Clinical Trial

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

Study acronym: INTerpath-002
Recruiting Phase 3
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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.
Protocol Amendment History 94 amendments
This ClinicalTrials.gov record has been amended 94 times since 2023-10-05; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2023-11-07
Trial Details
NCT Number NCT06077760
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: ModernaTX, Inc.
Conditions Non-small Cell Lung Cancer
Enrollment 868 participants
Start Date 2023-12-06
Primary Completion 2030-06-25 (estimated)
Study Completion 2035-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-31