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RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07513376

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Intismeran (Biological)
    IM injection
  • Pembrolizumab coformulated with berahyaluronidase alfa (Biological)
    SC injection
  • Placebo (Other)
    IM injection

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology * Has undergone a complete surgical resection of the primary NSCLC * Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC * Has provided a tissue sample from recent surgery along with the required blood sample * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs * Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy other than those permitted in protocol * Has history of stem cell/solid organ transplant * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Conditions

Non-small Cell Lung Cancer

Locations

  • UC Davis Comprehensive Cancer Center ( Site 3204) — Sacramento, California, United States
  • University of Colorado Cancer Center ( Site 3268) — Aurora, Colorado, United States
  • Smilow Cancer Center at Yale-New Haven ( Site 3253) — New Haven, Connecticut, United States
  • UF Health Cancer Center ( Site 3257) — Gainesville, Florida, United States
  • Illinois Cancer Care ( Site 7000) — Peoria, Illinois, United States
  • Washington University School of Medicine ( Site 3279) — St Louis, Missouri, 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
  • New York Oncology Hematology, P.C. ( Site 9000) — Albany, New York, United States
  • SUNY Upstate Medical University ( Site 3270) — Syracuse, New York, United States
  • White Plains Hospital ( Site 3213) — White Plains, New York, United States
  • Charles George VA Medical Center ( Site 3233) — Asheville, North Carolina, United States
  • UNC Lineberger Comprehensive Cancer Center ( Site 3250) — Chapel Hill, North Carolina, United States
  • WakeMed Raleigh Campus ( Site 3214) — Raleigh, North Carolina, United States
  • Sanford Fargo Medical Center ( Site 3236) — Fargo, North Dakota, United States
  • Altru Health System ( Site 3254) — Grand Forks, North Dakota, United States
  • Perelman Center for Advanced Medicine ( Site 3205) — Philadelphia, Pennsylvania, United States
  • Sanford Cancer Center ( Site 3266) — Sioux Falls, South Dakota, United States
  • Avera Cancer Institute ( Site 3209) — Sioux Falls, South Dakota, United States
  • The University of Tennessee Medical Center ( Site 3223) — Knoxville, Tennessee, United States
  • Hematology Oncology Associates of Fredericksburg ( Site 3275) — Fredericksburg, Virginia, United States
  • West Virginia University ( Site 3237) — Morgantown, West Virginia, United States
  • Gundersen Health System ( Site 3200) — La Crosse, Wisconsin, United States
  • Royal North Shore Hospital ( Site 0502) — St Leonards, New South Wales, Australia
  • Princess Alexandra Hospital ( Site 0503) — Brisbane, Queensland, Australia
  • One Clinical Research ( Site 0501) — Nedlands, Western Australia, Australia
  • Hospital de Clínicas de Passo Fundo ( Site 3601) — Pasos Fundo, Rio Grande do Sul, Brazil
  • Hospital Sírio Libanês ( Site 3611) — São Paulo, Brazil
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506) — Hamilton, Ontario, Canada
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503) — Kingston, Ontario, Canada
  • The Ottawa Hospital Cancer Centre ( Site 2508) — Ottawa, Ontario, Canada
  • Centre Hospitalier de l'Université de Montréal ( Site 2501) — Montreal, Quebec, Canada
  • Clínica MEDS La Dehesa ( Site 3708) — Lo Barnechea, Region M. de Santiago, Chile
  • Centro de Oncología de Precisión ( Site 3706) — Santiago, Region M. de Santiago, Chile
  • FALP-UIDO ( Site 3701) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill-Clinical Area ( Site 3700) — Santiago, Region M. de Santiago, Chile
  • ONCOCENTRO APYS-ACEREY ( Site 3704) — Viña del Mar, Valparaiso, Chile
  • Bradford Hill Norte ( Site 3705) — Antofagasta, Chile
  • Promotora Médica Las Américas S.A. ( Site 3800) — Medellín, Antioquia, Colombia
  • Clinica Somer ( Site 3802) — Rionegro, Antioquia, Colombia
  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3806) — Bogotá, Bogota D.C., Colombia
  • Clínica Universitaria Colombia ( Site 3803) — Bogotá, Bogota D.C., Colombia
  • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 3804) — Bogota, Cundinamarca, Colombia
  • Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S ( Site 3801) — Montería, Departamento de Córdoba, Colombia
  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 2605) — Rennes, Brittany Region, France
  • Hôpital Foch ( Site 2604) — Suresnes, Hauts-de-Seine, France
  • CHU GABRIEL MONTPIED ( Site 2608) — Clermont-Ferrand, Puy-de-Dome, France
  • Thoraxklinik-Heidelberg gGmbH ( Site 2703) — Heidelberg, Baden-Wurttemberg, Germany
  • Augusta-Kranken-Anstalt ( Site 2702) — Bochum, North Rhine-Westphalia, Germany
  • SRH Wald-Klinikum Gera ( Site 2700) — Gera, Thuringia, Germany
  • Errikos Dunant Hospital Center ( Site 5004) — Athens, Attica, Greece
  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001) — Athens, Attica, Greece
  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003) — 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
  • Nograd Varmegyei Szent Lazar Korhaz ( Site 4410) — Salgótarján, Nógrád megye, Hungary
  • Reformatus Pulmonologiai Centrum ( Site 4403) — Törökbálint, Pest 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
  • Rabin Medical Center ( Site 3304) — Petah Tikva, Israel
  • Sheba Medical Center ( Site 3302) — Ramat Gan, Israel
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 2804) — Bergamo, Lombardy, Italy
  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800) — Milan, Lombardy, Italy
  • Azienda Ospedaliera Universitaria Careggi ( Site 2806) — Florence, Tuscany, Italy
  • AO Santa Maria della Misericordia ( Site 2809) — Perugia, Umbria, Italy
  • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803) — Novara, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801) — Roma, Italy
  • Hospital of the University of Occupational and Environmental Health, Japan ( Site 5516) — Kitakyushu, Fukuoka, Japan
  • Fukushima Medical University Hospital ( Site 5501) — Fukushima, Japan
  • Yamagata University Hospital ( Site 5500) — Yamagata, Japan
  • Ziekenhuis St. Jansdal ( Site 4800) — Harderwijk, Gelderland, Netherlands
  • Radboudumc ( Site 4806) — Nijmegen, Gelderland, Netherlands
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809) — Amsterdam, North Holland, Netherlands
  • Elisabeth-TweeSteden Ziekenhuis ( Site 4801) — Tilburg, North Holland, Netherlands
  • Isala, locatie Zwolle ( Site 4804) — Zwolle, Overijssel, 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
  • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200) — Warsaw, Masovian 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
  • National Cancer Center ( Site 5202) — Goyang-si, Kyonggi-do, South Korea
  • Seoul National University Bundang Hospital ( Site 5200) — Seongnam-si, Kyonggi-do, South Korea
  • The Catholic University Of Korea St. Vincent's Hospital ( Site 5203) — Suwon, Kyonggi-do, South Korea
  • Chungbuk National University Hospital ( Site 5201) — Cheongju-si, North Chungcheong, South Korea
  • Asan Medical Center ( Site 5205) — Seoul, South Korea
  • Samsung Medical Center ( Site 5206) — Seoul, South Korea
  • ICO - Hospital Duran i Reynals ( Site 0301) — L'Hospitalet de Llobregat, Barcelona, Spain
  • Hospital de Cruces ( Site 0308) — Barakaldo, Bizkaia, Spain
  • Hospital Universitari Vall d'Hebron ( Site 0300) — Barcelona, Catalonia, Spain
  • Hospital Virgen de la Victoria ( Site 0309) — Málaga, Malaga, Spain
  • Hospital Universitario de Badajoz ( Site 0305) — Badajoz, 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
  • Hospital General de Valencia ( Site 0304) — Valencia, 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
  • Adana Medical Park Seyhan Hastanesi ( Site 4302) — Adana, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300) — Ankara, Turkey (Türkiye)
  • Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309) — Ankara, Turkey (Türkiye)
  • Ankara Bilkent Sehir Hastanesi ( Site 4306) — Ankara, Turkey (Türkiye)
  • İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307) — Istanbul, Turkey (Türkiye)
  • KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308) — Istanbul, Turkey (Türkiye)
  • Ege Universitesi Hastanesi ( Site 4301) — Izmir, Turkey (Türkiye)
  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304) — Kayseri, Turkey (Türkiye)
  • St Bartholomew's Hospital ( Site 0400) — London, London, City of, United Kingdom
  • Charing Cross Hospital ( Site 0407) — London, London, City of, United Kingdom
  • Singleton Hospital ( Site 0403) — Swansea, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record