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)

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 868 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Intismeran autogene	IM injection
BIOLOGICAL	Pembrolizumab	IV infusion
OTHER	Placebo	IM injection

Timeline

• Start date: 2023-12-06
• Primary completion: 2030-06-25
• Completion: 2035-12-21
• First posted: 2023-10-11
• Last updated: 2026-04-13

Locations

229 sites across 33 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Costa Rica, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study