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
UC Davis Comprehensive Cancer Center ( Site 3204)
Sacramento, California 95817
United States
University of Colorado Cancer Center ( Site 3268)
Aurora, Colorado 80045
United States
Smilow Cancer Center at Yale-New Haven ( Site 3253)
New Haven, Connecticut 06511
United States
Illinois Cancer Care ( Site 7000)
Peoria, Illinois 61615
United States
Washington University School of Medicine ( Site 3279)
St Louis, Missouri 63110
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
New York Oncology Hematology, P.C. ( Site 9000)
Albany, New York 12206
United States
White Plains Hospital ( Site 3213)
White Plains, New York 10601
United States
Charles George VA Medical Center ( Site 3233)
Asheville, North Carolina 28805
United States
UNC Lineberger Comprehensive Cancer Center ( Site 3250)
Chapel Hill, North Carolina 27514
United States
WakeMed Raleigh Campus ( Site 3214)
Raleigh, North Carolina 27610
United States
Sanford Fargo Medical Center ( Site 3236)
Fargo, North Dakota 58102
United States
Altru Health System ( Site 3254)
Grand Forks, North Dakota 58201
United States
Perelman Center for Advanced Medicine ( Site 3205)
Philadelphia, Pennsylvania 19104
United States
Sanford Cancer Center ( Site 3266)
Sioux Falls, South Dakota 57104
United States
Avera Cancer Institute ( Site 3209)
Sioux Falls, South Dakota 57105
United States
The University of Tennessee Medical Center ( Site 3223)
Knoxville, Tennessee 37920
United States
Hematology Oncology Associates of Fredericksburg ( Site 3275)
Fredericksburg, Virginia 22408
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
Princess Alexandra Hospital ( Site 0503)
Brisbane, Queensland 4102
Australia
One Clinical Research ( Site 0501)
Nedlands, Western Australia 6009
Australia
Hospital Sírio Libanês ( Site 3611)
São Paulo, 01308-060
Brazil
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
Clínica MEDS La Dehesa ( Site 3708)
Lo Barnechea, Region M. de Santiago 7691236
Chile
Centro de Oncología de Precisión ( Site 3706)
Santiago, Region M. de Santiago 7500000
Chile
Bradfordhill-Clinical Area ( Site 3700)
Santiago, Region M. de Santiago 8420383
Chile
ONCOCENTRO APYS-ACEREY ( Site 3704)
Viña del Mar, Valparaiso 2520598
Chile
Bradford Hill Norte ( Site 3705)
Antofagasta, 2520598
Chile
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 2605)
Rennes, Brittany Region 35000
France
Hôpital Foch ( Site 2604)
Suresnes, Hauts-de-Seine 92150
France
CHU GABRIEL MONTPIED ( Site 2608)
Clermont-Ferrand, Puy-de-Dome 63000
France
Thoraxklinik-Heidelberg gGmbH ( Site 2703)
Heidelberg, Baden-Wurttemberg 69126
Germany
Augusta-Kranken-Anstalt ( Site 2702)
Bochum, North Rhine-Westphalia 44791
Germany
Errikos Dunant Hospital Center ( Site 5004)
Athens, Attica 115 26
Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)
Athens, Attica 115 27
Greece
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)
Athens, Attica 124 62
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
Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)
Salgótarján, Nógrád megye 3100
Hungary
Reformatus Pulmonologiai Centrum ( Site 4403)
Törökbálint, Pest County 2045
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
Rabin Medical Center ( Site 3304)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 3302)
Ramat Gan, 5265601
Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 2804)
Bergamo, Lombardy 24127
Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)
Milan, Lombardy 20133
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2806)
Florence, Tuscany 50134
Italy
AO Santa Maria della Misericordia ( Site 2809)
Perugia, Umbria 06132
Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
Novara, 28100
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)
Roma, 00168
Italy
Fukushima Medical University Hospital ( Site 5501)
Fukushima, 960-1295
Japan
Ziekenhuis St. Jansdal ( Site 4800)
Harderwijk, Gelderland 3844 DG
Netherlands
Radboudumc ( Site 4806)
Nijmegen, Gelderland 6525 GA
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)
Amsterdam, North Holland 1066 CX
Netherlands
Elisabeth-TweeSteden Ziekenhuis ( Site 4801)
Tilburg, North Holland 5022 GC
Netherlands
Isala, locatie Zwolle ( Site 4804)
Zwolle, Overijssel 8025 AB
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
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)
Warsaw, Masovian Voivodeship 01-138
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
National Cancer Center ( Site 5202)
Goyang-si, Kyonggi-do 10408
South Korea
Seoul National University Bundang Hospital ( Site 5200)
Seongnam-si, Kyonggi-do 13620
South Korea
The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)
Suwon, Kyonggi-do 16247
South Korea
Chungbuk National University Hospital ( Site 5201)
Cheongju-si, North Chungcheong 28644
South Korea
Asan Medical Center ( Site 5205)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 5206)
Seoul, 06351
South Korea
ICO - Hospital Duran i Reynals ( Site 0301)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital de Cruces ( Site 0308)
Barakaldo, Bizkaia 48903
Spain
Hospital Universitari Vall d'Hebron ( Site 0300)
Barcelona, Catalonia 08035
Spain
Hospital Virgen de la Victoria ( Site 0309)
Málaga, Malaga 29010
Spain
Hospital Universitario de Badajoz ( Site 0305)
Badajoz, 06006
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
Hospital General de Valencia ( Site 0304)
Valencia, 46014
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
Adana Medical Park Seyhan Hastanesi ( Site 4302)
Adana, 1140
Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
Ankara, 6230
Turkey (Türkiye)
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)
Ankara, 6280
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 4306)
Ankara, 6800
Turkey (Türkiye)
İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)
Istanbul, 34010
Turkey (Türkiye)
KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)
Istanbul, 34890
Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 4301)
Izmir, 35100
Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)
Kayseri, 38039
Turkey (Türkiye)
St Bartholomew's Hospital ( Site 0400)
London, London, City of EC1A 7BE
United Kingdom
Charing Cross Hospital ( Site 0407)
London, London, City of W6 8RF
United Kingdom
Singleton Hospital ( Site 0403)
Swansea, SA2 8QA
United Kingdom