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Recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT07513376

Public ClinicalTrials.gov record NCT07513376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07513376
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
876 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 3, 2026
Primary completion
Aug 21, 2034
Completion
May 10, 2038
Last update posted
Aug 25, 2026

2026 – 2038

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
UC Davis Comprehensive Cancer Center ( Site 3204) Sacramento California 95817 Recruiting
Smilow Cancer Center at Yale-New Haven ( Site 3253) New Haven Connecticut 06511 Recruiting
Billings Clinic ( Site 3255) Billings Montana 59101 Recruiting
NHO Revive Research Institute, LLC ( Site 3218) Lincoln Nebraska 68506 Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) Reno Nevada 89502 Recruiting
White Plains Hospital ( Site 3213) White Plains New York 10601 Recruiting
Charles George VA Medical Center ( Site 3233) Asheville North Carolina 28805 Recruiting
WakeMed Raleigh Campus ( Site 3214) Raleigh North Carolina 27610 Recruiting
Altru Health System ( Site 3254) Grand Forks North Dakota 58201 Recruiting
Avera Cancer Institute ( Site 3209) Sioux Falls South Dakota 57105 Recruiting
The University of Tennessee Medical Center ( Site 3223) Knoxville Tennessee 37920 Recruiting
West Virginia University ( Site 3237) Morgantown West Virginia 26506 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07513376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07513376 live on ClinicalTrials.gov.

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