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A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)

Study acronym: INTerpath-014
StatusRecruiting
PhasePhase 3
Started2026-05-04
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
minor
Study Status, Contacts/Locations v17
Trial sites expanded: 94 → 104 locations
Trial sites expanded: 86 → 93 locations
Trial sites expanded: 76 → 86 locations
2026-08-25
minor
Study Status, Contacts/Locations v16
Trial sites expanded: 68 → 76 locations
2026-08-20
minor
Study Status, Contacts/Locations v15
Trial sites expanded: 60 → 68 locations
2026-08-13
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 56 → 60 locations
2026-08-12
minor
Study Identification, Study Status v13
Re-verified, no change to tracked fields
2026-08-06
minor
Study Status, Contacts/Locations v12
Trial sites expanded: 46 → 56 locations
2026-07-30
minor
Study Status, Contacts/Locations v11
Trial sites expanded: 42 → 46 locations
2026-07-24
minor
Study Status, Contacts/Locations v10
Trial sites expanded: 35 → 42 locations
2026-07-15
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 29 → 35 locations
2026-07-09
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 17 → 29 locations
2026-07-01
minor
Study Status, Contacts/Locations, References v7
Trial sites expanded: 10 → 17 locations
2026-06-11
minor
Study Status, Contacts/Locations v6
Study sites8→10
2026-06-05
minor
Study Status, Contacts/Locations v5
Study sites7→8
2026-05-27
minor
Study Status, Contacts/Locations v4
Study sites6→7
2026-05-22
minor
Study Status, Contacts/Locations v3
Study sites5→6
2026-05-13
notable
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 0 → 3 locations
2026-05-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-05-11→confirmed 2026-05-04
Study sites0→3
2026-04-01
minor
Original filing
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
Trial Details
NCT Number NCT07513376
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: ModernaTX, Inc.
Conditions Non-small Cell Lung Cancer
Enrollment 876 participants
Start Date 2026-05-04
Primary Completion 2034-08-22 (estimated)
Study Completion 2038-05-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01