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)
Start Date
5/4/2026
Completion Date
5/11/2038
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 Criteria
Age Range: 18 years to No maximum
Interventions
Intismeran
Pembrolizumab coformulated with berahyaluronidase alfa
Placebo
Conditions
Locations
Smilow Cancer Center at Yale-New Haven ( Site 3253)
New Haven, Connecticut 06511
United States
Billings Clinic ( Site 3255)
Billings, Montana 59101
United States
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska 68506
United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada 89502
United States
White Plains Hospital ( Site 3213)
White Plains, New York 10601
United States
WakeMed Raleigh Campus ( Site 3214)
Raleigh, North Carolina 27610
United States
Altru Health System ( Site 3254)
Grand Forks, North Dakota 58201
United States
The University of Tennessee Medical Center ( Site 3223)
Knoxville, Tennessee 37920
United States
West Virginia University ( Site 3237)
Morgantown, West Virginia 26506
United States
Royal North Shore Hospital ( Site 0502)
St Leonards, New South Wales 2065
Australia
One Clinical Research ( Site 0501)
Nedlands, Western Australia 6009
Australia
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
Hamilton, Ontario L8V 5C2
Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
Kingston, Ontario K7L 2V7
Canada
Centre Hospitalier de l'Université de Montréal ( Site 2501)
Montreal, Quebec H2X 3E4
Canada
Augusta-Kranken-Anstalt ( Site 2702)
Bochum, North Rhine-Westphalia 44791
Germany
Errikos Dunant Hospital Center ( Site 5004)
Athens, Attica 115 26
Greece
European Interbalkan Medical Center-Oncology Department ( Site 5000)
Thessaloniki, 570 01
Greece
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
Pécs, Baranya 7623
Hungary
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)
Miskolc, Borsod-Abauj Zemplen county 3526
Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)
Kecskemét, Bács-Kiskun county 6000
Hungary
Országos Onkológiai Intézet ( Site 4405)
Budapest, 1122
Hungary
Rambam Health Care Campus ( Site 3303)
Haifa, 3109601
Israel
Shaare Zedek Medical Center ( Site 3301)
Jerusalem, 9103102
Israel
Hadassah Medical Center ( Site 3305)
Jerusalem, 9112001
Israel
Meir medical center ( Site 3306)
Kfar Saba, 4428164
Israel
Sheba Medical Center ( Site 3302)
Ramat Gan, 5265601
Israel
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
Novara, 28100
Italy
Ziekenhuis St. Jansdal ( Site 4800)
Harderwijk, Gelderland 3844 DG
Netherlands
Radboudumc ( Site 4806)
Nijmegen, Gelderland 6525 GA
Netherlands
Frisius Medisch Centrum ( Site 4808)
Leeuwarden, Provincie Friesland 8934 AD
Netherlands
Meander Medisch Centrum ( Site 4802)
Amersfoort, Utrecht 3813 TZ
Netherlands
University Medical Center Groningen ( Site 4807)
Groningen, 9713 GZ
Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)
Poznan, Greater Poland Voivodeship 60-569
Poland
IP Clinic ( Site 4204)
Lodz, Łódź Voivodeship 90-752
Poland
Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)
Chęciny, Świętokrzyskie Voivodeship 26-060
Poland
Hospital de Cruces ( Site 0308)
Barakaldo, Bizkaia 48903
Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)
Madrid, 28009
Spain
Hospital Clinico San Carlos ( Site 0303)
Madrid, 28040
Spain
Hospital Universitario Virgen Macarena ( Site 0306)
Seville, 41007
Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)
Kaohsiung City, 83301
Taiwan
China Medical University Hospital ( Site 5303)
Taichung, 40447
Taiwan
Taichung Veterans General Hospital ( Site 5301)
Taichung, 407
Taiwan
National Cheng Kung University Hospital ( Site 5300)
Tainan, 704
Taiwan
Taipei Medical University Hospital ( Site 5305)
Taipei, 110
Taiwan
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
Ankara, 6230
Turkey (Türkiye)
İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)
Istanbul, 34010
Turkey (Türkiye)