AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3INTerpath-014NCT07513376

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 study testing Intismeran and Pembrolizumab coformulated with berahyaluronidase alfa in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 124 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Intismeran and Pembrolizumab coformulated with berahyaluronidase alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
876 participants
Where
124 sitesin 20 countries
Study dates
4 May 2026to 11 May 2038
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

124 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

124 sites in 20 countries

United States26 sites, 26 recruiting

  • New York Oncology Hematology, P.C. ( Site 9000)

    Albany, New York, 12206

    Study Coordinator, 518-489-0044

    Recruiting

  • Charles George VA Medical Center ( Site 3233)

    Asheville, North Carolina, 28805

    Study Coordinator, 828-298-7911

    Recruiting

  • University of Colorado Cancer Center ( Site 3268)

    Aurora, Colorado, 80045

    Study Coordinator, 720-848-0300

    Recruiting

  • Billings Clinic ( Site 3255)

    Billings, Montana, 59101

    Study Coordinator, 406-435-7480

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center ( Site 3250)

    Chapel Hill, North Carolina, 27514

    Study Coordinator, 919-966-4432

    Recruiting

  • Sanford Fargo Medical Center ( Site 3236)

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-7563

    Recruiting

  • Hematology Oncology Associates of Fredericksburg ( Site 3275)

    Fredericksburg, Virginia, 22408

    Study Coordinator, 540-371-0079

    Recruiting

  • UF Health Cancer Center ( Site 3257)

    Gainesville, Florida, 32610

    Study Coordinator, 352-273-8010

    Recruiting

  • Altru Health System ( Site 3254)

    Grand Forks, North Dakota, 58201

    Study Coordinator, 701-780-5400

    Recruiting

  • University of Texas-MD Anderson Cancer Center ( Site 3283)

    Houston, Texas, 77030

    Study Coordinator, 713-792-6363

    Recruiting

  • The University of Tennessee Medical Center ( Site 3223)

    Knoxville, Tennessee, 37920

    Study Coordinator, 865-305-8780

    Recruiting

  • Gundersen Health System ( Site 3200)

    La Crosse, Wisconsin, 54601

    Study Coordinator, 608-775-2385

    Recruiting

  • NHO Revive Research Institute, LLC ( Site 3218)

    Lincoln, Nebraska, 68506

    Study Coordinator, 402-484-4900

    Recruiting

  • West Virginia University ( Site 3237)

    Morgantown, West Virginia, 26506

    Study Coordinator, 304-598-4500

    Recruiting

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

    New Haven, Connecticut, 06511

    Study Coordinator, 203-688-4242

    Recruiting

  • Illinois Cancer Care ( Site 7000)

    Peoria, Illinois, 61615

    Study Coordinator, 309-240-6040

    Recruiting

  • Perelman Center for Advanced Medicine ( Site 3205)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 267-275-3770

    Recruiting

  • WakeMed Raleigh Campus ( Site 3214)

    Raleigh, North Carolina, 27610

    Study Coordinator, 919-350-2873

    Recruiting

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

    Reno, Nevada, 89502

    Study Coordinator, 775-982-4000

    Recruiting

  • UC Davis Comprehensive Cancer Center ( Site 3204)

    Sacramento, California, 95817

    Study Coordinator, 916-734-5959

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 3202)

    Seattle, Washington, 98109

    Study Coordinator, 206-606-4801

    Recruiting

  • Sanford Cancer Center ( Site 3266)

    Sioux Falls, South Dakota, 57104

    Study Coordinator, 605-312-3250

    Recruiting

  • Avera Cancer Institute ( Site 3209)

    Sioux Falls, South Dakota, 57105

    Study Coordinator, 605-322-3000

    Recruiting

  • Washington University School of Medicine ( Site 3279)

    St Louis, Missouri, 63110

    Study Coordinator, 314-362-5000

    Recruiting

  • SUNY Upstate Medical University ( Site 3270)

    Syracuse, New York, 13210

    Study Coordinator, 315-464-8237

    Recruiting

  • White Plains Hospital ( Site 3213)

    White Plains, New York, 10601

    Study Coordinator, 914-849-7500

    Recruiting

Other trials in United States

Spain9 sites, 9 recruiting

  • Hospital Universitario de Badajoz ( Site 0305)

    Badajoz, 06006

    Study Coordinator, +34924218040

    Recruiting

  • Hospital de Cruces ( Site 0308)

    Barakaldo, Bizkaia, 48903

    Study Coordinator, +34946006399

    Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 0300)

    Barcelona, Catalonia, 08035

    Study Coordinator, +34932746000

    Recruiting

  • ICO - Hospital Duran i Reynals ( Site 0301)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

    Madrid, 28009

    Study Coordinator, +34915868115

    Recruiting

  • Hospital Clinico San Carlos ( Site 0303)

    Madrid, 28040

    Study Coordinator, +34913303000

    Recruiting

  • Hospital Virgen de la Victoria ( Site 0309)

    Málaga, Malaga, 29010

    Study Coordinator, +34671594566

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 0306)

    Seville, 41007

    Study Coordinator, +34955008000

    Recruiting

  • Hospital General de Valencia ( Site 0304)

    Valencia, 46014

    Study Coordinator, +34963187527

    Recruiting

Other trials in Spain

Netherlands8 sites, 8 recruiting

  • Meander Medisch Centrum ( Site 4802)

    Amersfoort, Utrecht, 3813 TZ

    Study Coordinator, +31338507843

    Recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205129111

    Recruiting

  • University Medical Center Groningen ( Site 4807)

    Groningen, 9713 GZ

    Study Coordinator, +31503614679

    Recruiting

  • Ziekenhuis St. Jansdal ( Site 4800)

    Harderwijk, Gelderland, 3844 DG

    Study Coordinator, +31341463742

    Recruiting

  • Frisius Medisch Centrum ( Site 4808)

    Leeuwarden, Provincie Friesland, 8934 AD

    Study Coordinator, +31503614679

    Recruiting

  • Radboudumc ( Site 4806)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31243610353

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis ( Site 4801)

    Tilburg, North Holland, 5022 GC

    Study Coordinator, +31132213101

    Recruiting

  • Isala, locatie Zwolle ( Site 4804)

    Zwolle, Overijssel, 8025 AB

    Study Coordinator, 088-6243254

    Recruiting

Other trials in Netherlands

Turkey (Türkiye)8 sites, 8 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 4302)

    Adana, 1140

    Study Coordinator, +905056166338

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

    Ankara, 6230

    Study Coordinator, +905523567926

    Recruiting

  • Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)

    Ankara, 6280

    Study Coordinator, +905360653456

    Recruiting

  • Ankara Bilkent Sehir Hastanesi ( Site 4306)

    Ankara, 6800

    Study Coordinator, +903125526000

    Recruiting

  • İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)

    Istanbul, 34010

    Study Coordinator, +90549872864

    Recruiting

  • KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)

    Istanbul, 34890

    Study Coordinator, +905367197395

    Recruiting

  • Ege Universitesi Hastanesi ( Site 4301)

    Izmir, 35100

    Study Coordinator, 905322202675

    Recruiting

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)

    Kayseri, 38039

    Study Coordinator, +905388731881

    Recruiting

Other trials in Turkey (Türkiye)

Hungary7 sites, 7 recruiting

  • Országos Onkológiai Intézet ( Site 4405)

    Budapest, 1122

    Study Coordinator, +3612248600

    Recruiting

  • Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 4404)

    Győr, Győr-Moson-Sopron, 9024

    Study Coordinator, +36 96 507 900

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)

    Kecskemét, Bács-Kiskun county, 6000

    Study Coordinator, +3676516700/6719

    Recruiting

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

    Miskolc, Borsod-Abauj Zemplen county, 3526

    Study Coordinator, +36304835188

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

    Pécs, Baranya, 7623

    Study Coordinator, +36 72 535890

    Recruiting

  • Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)

    Salgótarján, Nógrád megye, 3100

    Study Coordinator, +3632522000

    Recruiting

  • Reformatus Pulmonologiai Centrum ( Site 4403)

    Törökbálint, Pest County, 2045

    Study Coordinator, +36 23 511 570

    Recruiting

Other trials in Hungary

Chile6 sites, 6 recruiting

  • Bradford Hill Norte ( Site 3705)

    Antofagasta, 2520598

    Study Coordinator, +5644232023631

    Recruiting

  • Clínica MEDS La Dehesa ( Site 3708)

    Lo Barnechea, Region M. de Santiago, 7691236

    Study Coordinator, +56229015945

    Recruiting

  • Centro de Oncología de Precisión ( Site 3706)

    Santiago, Region M. de Santiago, 7500000

    Study Coordinator, +56225189885

    Recruiting

  • FALP-UIDO ( Site 3701)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56226062331

    Recruiting

  • Bradfordhill-Clinical Area ( Site 3700)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56 229490970

    Recruiting

  • ONCOCENTRO APYS-ACEREY ( Site 3704)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320860

    Recruiting

Other trials in Chile

Colombia6 sites, 6 recruiting

  • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 3804)

    Bogota, Cundinamarca, 111151

    Study Coordinator, +573108658288

    Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3806)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +573219198898

    Recruiting

  • Clínica Universitaria Colombia ( Site 3803)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, +573016254437

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 3800)

    Medellín, Antioquia, 050021

    Study Coordinator, +570343421010

    Recruiting

  • Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S ( Site 3801)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +576047862333

    Recruiting

  • Clinica Somer ( Site 3802)

    Rionegro, Antioquia, 054040

    Study Coordinator, +5746052626

    Recruiting

Other trials in Colombia

Israel6 sites, 6 recruiting

  • Rambam Health Care Campus ( Site 3303)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Shaare Zedek Medical Center ( Site 3301)

    Jerusalem, 9103102

    Study Coordinator, +97226555999

    Recruiting

  • Hadassah Medical Center ( Site 3305)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Meir medical center ( Site 3306)

    Kfar Saba, 4428164

    Study Coordinator, +97297472555

    Recruiting

  • Rabin Medical Center ( Site 3304)

    Petah Tikva, 4941492

    Study Coordinator, 972-3-9378086

    Recruiting

  • Sheba Medical Center ( Site 3302)

    Ramat Gan, 5265601

    Study Coordinator, +97235307096

    Recruiting

Other trials in Israel

Italy6 sites, 6 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 2804)

    Bergamo, Lombardy, 24127

    Study Coordinator, +390352673694

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 2806)

    Florence, Tuscany, 50134

    Study Coordinator, 00390557947298

    Recruiting

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)

    Milan, Lombardy, 20133

    Study Coordinator, +390223903816

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

    Novara, 28100

    Study Coordinator, 003903213732296

    Recruiting

  • AO Santa Maria della Misericordia ( Site 2809)

    Perugia, Umbria, 06132

    Study Coordinator, +390755782661

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)

    Roma, 00168

    Study Coordinator, +390630155202

    Recruiting

Other trials in Italy

South Korea6 sites, 6 recruiting

  • Chungbuk National University Hospital ( Site 5201)

    Cheongju-si, North Chungcheong, 28644

    Study Coordinator, +82432696015

    Recruiting

  • National Cancer Center ( Site 5202)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82-31-920-1676

    Recruiting

  • Seoul National University Bundang Hospital ( Site 5200)

    Seongnam-si, Kyonggi-do, 13620

    Study Coordinator, +82317877071

    Recruiting

  • Asan Medical Center ( Site 5205)

    Seoul, 05505

    Study Coordinator, +82230103214

    Recruiting

  • Samsung Medical Center ( Site 5206)

    Seoul, 06351

    Study Coordinator, +82-2-3410-1132

    Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)

    Suwon, Kyonggi-do, 16247

    Study Coordinator, 82-31-249-7744

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

    Kaohsiung City, 83301

    Study Coordinator, +886 7-7317123

    Recruiting

  • China Medical University Hospital ( Site 5303)

    Taichung, 40447

    Study Coordinator, +886422052121

    Recruiting

  • Taichung Veterans General Hospital ( Site 5301)

    Taichung, 407

    Study Coordinator, +886423592525

    Recruiting

  • National Cheng Kung University Hospital ( Site 5300)

    Tainan, 704

    Study Coordinator, +88662353535

    Recruiting

  • Taipei Medical University Hospital ( Site 5305)

    Taipei, 110

    Study Coordinator, +886227372181

    Recruiting

Other trials in Taiwan

Canada4 sites, 4 recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

    Hamilton, Ontario, L8V 5C2

    Study Coordinator, 905-387-9495

    Recruiting

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

    Kingston, Ontario, K7L 2V7

    Study Coordinator, 6135496666

    Recruiting

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

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 5148908000x26832

    Recruiting

  • The Ottawa Hospital Cancer Centre ( Site 2508)

    Ottawa, Ontario, K1H 8L6

    Study Coordinator, 613-722-7000

    Recruiting

Other trials in Canada

Greece4 sites, 4 recruiting

  • Errikos Dunant Hospital Center ( Site 5004)

    Athens, Attica, 115 26

    Study Coordinator, +302107470960

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)

    Athens, Attica, 115 27

    Study Coordinator, +302107700220

    Recruiting

  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)

    Athens, Attica, 124 62

    Study Coordinator, 302105832549

    Recruiting

  • European Interbalkan Medical Center-Oncology Department ( Site 5000)

    Thessaloniki, 570 01

    Study Coordinator, +302310400213

    Recruiting

Other trials in Greece

Poland4 sites, 4 recruiting

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

    Chęciny, Świętokrzyskie Voivodeship, 26-060

    Study Coordinator, +48413465545wew256

    Recruiting

  • IP Clinic ( Site 4204)

    Lodz, Łódź Voivodeship, 90-752

    Study Coordinator, +48 48 42 208 97 98

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

    Poznan, Greater Poland Voivodeship, 60-569

    Study Coordinator, +48616654242

    Recruiting

  • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)

    Warsaw, Masovian Voivodeship, 01-138

    Study Coordinator, +48224312360

    Recruiting

Other trials in Poland

United Kingdom4 sites, 4 recruiting

  • St Bartholomew's Hospital ( Site 0400)

    London, London, City of, EC1A 7BE

    Study Coordinator, 0203 765 8544

    Recruiting

  • University College London Hospitals ( Site 0406)

    London, London, City of, NW1 2PG

    Study Coordinator, +442034567890

    Recruiting

  • Charing Cross Hospital ( Site 0407)

    London, London, City of, W6 8RF

    Study Coordinator, 020 331 10291

    Recruiting

  • Singleton Hospital ( Site 0403)

    Swansea, SA2 8QA

    Study Coordinator, 01792205666

    Recruiting

Other trials in United Kingdom

Australia3 sites, 3 recruiting

  • Princess Alexandra Hospital ( Site 0503)

    Brisbane, Queensland, 4102

    Study Coordinator, 0731762111

    Recruiting

  • One Clinical Research ( Site 0501)

    Nedlands, Western Australia, 6009

    Study Coordinator, +61410565868

    Recruiting

  • Royal North Shore Hospital ( Site 0502)

    St Leonards, New South Wales, 2065

    Study Coordinator, +61299267111

    Recruiting

Other trials in Australia

Brazil3 sites, 3 recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 3601)

    Pasos Fundo, Rio Grande do Sul, 99010-260

    Study Coordinator, +5554981271411

    Recruiting

  • Hospital Samaritano De Sao Paulo ( Site 3612)

    São Paulo, 01232-010

    Study Coordinator, 551138215871

    Recruiting

  • Hospital Sírio Libanês ( Site 3611)

    São Paulo, 01308-060

    Study Coordinator, +5511994125414

    Recruiting

Other trials in Brazil

France3 sites, 3 recruiting

  • CHU GABRIEL MONTPIED ( Site 2608)

    Clermont-Ferrand, Puy-de-Dome, 63000

    Study Coordinator, +33473754440

    Recruiting

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 2605)

    Rennes, Brittany Region, 35000

    Study Coordinator, +33299283738

    Recruiting

  • Hôpital Foch ( Site 2604)

    Suresnes, Hauts-de-Seine, 92150

    Study Coordinator, +33146252000

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Augusta-Kranken-Anstalt ( Site 2702)

    Bochum, North Rhine-Westphalia, 44791

    Study Coordinator, 00492345172453

    Recruiting

  • SRH Wald-Klinikum Gera ( Site 2700)

    Gera, Thuringia, 07548

    Study Coordinator, +493658280

    Recruiting

  • Thoraxklinik-Heidelberg gGmbH ( Site 2703)

    Heidelberg, Baden-Wurttemberg, 69126

    Study Coordinator, +4962213960

    Recruiting

Other trials in Germany

Japan3 sites, 3 recruiting

  • Fukushima Medical University Hospital ( Site 5501)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan ( Site 5516)

    Kitakyushu, Fukuoka, 807-8556

    Study Coordinator, +81-93-603-1611

    Recruiting

  • Yamagata University Hospital ( Site 5500)

    Yamagata, 990-9585

    Study Coordinator, +81-23-633-1122

    Recruiting

Other trials in Japan

About this study

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)

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.

Being tested
Intismeran, Pembrolizumab coformulated with berahyaluronidase alfa, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IntismeranBiological

    Also called V940, mRNA-4157

    IM injection

  • Pembrolizumab coformulated with berahyaluronidase alfaBiological

    Also called MK-3475A

    SC injection

  • PlaceboOther

    IM injection

Study groups in NCT07513376
Study groupRoleWhat they receive
Arm A: Intismeran + Pembrolizumab with Berahyaluronidase AlfaExperimentalParticipants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.
Receives: Biological: Intismeran; Biological: Pembrolizumab coformulated with berahyaluronidase alfa
Arm B: IntismeranExperimentalParticipants will receive intismeran 1 mg via IM injection.
Receives: Biological: Intismeran
Arm C: PlaceboPlacebo comparatorParticipants will receive dose-matched placebo via IM injection.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C

    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 98 months

Secondary outcomes (8)

  1. DFS as Assessed by BICR

    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 98 months

  2. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

    Measured: Up to approximately 111 months

  3. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 123 months

  4. Number Participants Who Experience an Adverse Events (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 144 months

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 144 months

  6. Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.

    Measured: Baseline and up to approximately 36 months

  7. Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.

    Measured: Baseline and up to approximately 36 months

  8. Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.

    Measured: Baseline and up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start4 May 2026
  3. Primary completion22 Aug 2034 (estimated)
  4. Study completion11 May 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
876 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513376
Sponsor's protocol ID
V940-014
Other IDs
V940-014, U1111-1323-9950, 2025-522643-18-00, jRCT2021260028, 2025
Acronym
INTerpath-014
Status last verified
Oct 2026
First submitted
1 Apr 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intismeran and Pembrolizumab coformulated with berahyaluronidase alfa in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 124 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Spain, Netherlands, Turkey (Türkiye), Hungary and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C (time frame: Up to approximately 98 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07513376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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