RecruitingPhase 3NCT07513376

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)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

876 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Intismeran, a biological treatment called Pembrolizumab coformulated with berahyaluronidase alfa, and others for people with non-small cell lung cancer. The study is currently recruiting participants at 29 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntismeran

IM injection

BIOLOGICALPembrolizumab coformulated with berahyaluronidase alfa

SC injection

OTHERPlacebo

IM injection

Locations(46)

Smilow Cancer Center at Yale-New Haven ( Site 3253)

New Haven, Connecticut, United States

Billings Clinic ( Site 3255)

Billings, Montana, United States

NHO Revive Research Institute, LLC ( Site 3218)

Lincoln, Nebraska, United States

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)

Reno, Nevada, United States

White Plains Hospital ( Site 3213)

White Plains, New York, United States

WakeMed Raleigh Campus ( Site 3214)

Raleigh, North Carolina, United States

Altru Health System ( Site 3254)

Grand Forks, North Dakota, United States

The University of Tennessee Medical Center ( Site 3223)

Knoxville, Tennessee, United States

West Virginia University ( Site 3237)

Morgantown, West Virginia, United States

Royal North Shore Hospital ( Site 0502)

St Leonards, New South Wales, Australia

One Clinical Research ( Site 0501)

Nedlands, Western Australia, Australia

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Hamilton, Ontario, Canada

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)

Kingston, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 2501)

Montreal, Quebec, Canada

Augusta-Kranken-Anstalt ( Site 2702)

Bochum, North Rhine-Westphalia, Germany

Errikos Dunant Hospital Center ( Site 5004)

Athens, Attica, Greece

European Interbalkan Medical Center-Oncology Department ( Site 5000)

Thessaloniki, Greece

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

Pécs, Baranya, Hungary

Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)

Miskolc, Borsod-Abauj Zemplen county, Hungary

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)

Kecskemét, Bács-Kiskun county, Hungary

Országos Onkológiai Intézet ( Site 4405)

Budapest, Hungary

Rambam Health Care Campus ( Site 3303)

Haifa, Israel

Shaare Zedek Medical Center ( Site 3301)

Jerusalem, Israel

Hadassah Medical Center ( Site 3305)

Jerusalem, Israel

Meir medical center ( Site 3306)

Kfar Saba, Israel

Sheba Medical Center ( Site 3302)

Ramat Gan, Israel

Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

Novara, Italy

Ziekenhuis St. Jansdal ( Site 4800)

Harderwijk, Gelderland, Netherlands

Radboudumc ( Site 4806)

Nijmegen, Gelderland, Netherlands

Frisius Medisch Centrum ( Site 4808)

Leeuwarden, Provincie Friesland, Netherlands

Meander Medisch Centrum ( Site 4802)

Amersfoort, Utrecht, Netherlands

University Medical Center Groningen ( Site 4807)

Groningen, Netherlands

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

Poznan, Greater Poland Voivodeship, Poland

IP Clinic ( Site 4204)

Lodz, Łódź Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)

Chęciny, Świętokrzyskie Voivodeship, Poland

Hospital de Cruces ( Site 0308)

Barakaldo, Bizkaia, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

Madrid, Spain

Hospital Clinico San Carlos ( Site 0303)

Madrid, Spain

Hospital Universitario Virgen Macarena ( Site 0306)

Seville, Spain

Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

Kaohsiung City, Taiwan

China Medical University Hospital ( Site 5303)

Taichung, Taiwan

Taichung Veterans General Hospital ( Site 5301)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 5300)

Tainan, Taiwan

Taipei Medical University Hospital ( Site 5305)

Taipei, Taiwan

Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

Ankara, Turkey (Türkiye)

İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)

Istanbul, Turkey (Türkiye)

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NCT07513376

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