AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3INTerpath-002NCT06077760

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

A Phase 3 study testing Intismeran autogene and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 229 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). 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 autogene and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
868 participants
Where
229 sitesin 33 countries
Study dates
6 Dec 2023to 21 Dec 2035
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 undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
  • Has no evidence of disease before randomization.
  • Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
  • No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
  • 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.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Received prior neoadjuvant therapy for their current NSCLC diagnosis.
  • Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
  • Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
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  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
  • Known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Active infection requiring systemic therapy.

Trial locations and contacts

229 sites in 33 countries.

229 sites in 33 countries

United States68 sites

  • Summa Health ( Site 4011)

    Akron, Ohio, 44304

  • New York Oncology Hematology, P.C. ( Site 4012)

    Albany, New York, 12206

  • Alaska Oncology and Hematology ( Site 0039)

    Anchorage, Alaska, 99508

  • University of Michigan Clinical Trials Office ( Site 0058)

    Ann Arbor, Michigan, 48109

  • Memorial Sloan Kettering - Basking Ridge ( Site 4056)

    Basking Ridge, New Jersey, 07920

  • LSU Health Baton Rouge North Clinic ( Site 4040)

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake ( Site 4050)

    Baton Rouge, Louisiana, 70808

  • St. Vincent Frontier Cancer Center ( Site 0043)

    Billings, Montana, 59102

  • Medical University of South Carolina-Hollings Cancer Center ( Site 0050)

    Charleston, South Carolina, 29425

  • Novant Health Weisiger Cancer Insititute ( Site 4052)

    Charlotte, North Carolina, 28204

  • Greco-Hainsworth Centers for Research ( Site 4034)

    Chattanooga, Tennessee, 37421

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)

    Cincinnati, Ohio, 45220

  • University Hospitals Cleveland Medical Center ( Site 0023)

    Cleveland, Ohio, 44106

  • UCHealth Memorial Hospital-Heme Onc ( Site 0052)

    Colorado Springs, Colorado, 80909

  • OSU Brain and Spine Hospital ( Site 0016)

    Columbus, Ohio, 43210

  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)

    Commack, New York, 11725

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)

    Corvallis, Oregon, 97330

  • UT Southwestern Medical Center ( Site 0061)

    Dallas, Texas, 75390

  • Saint Elizabeth Healthcare ( Site 0092)

    Edgewood, Kentucky, 41017

  • Inova Schar Cancer Institute ( Site 0003)

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists (VCS) ( Site 4004)

    Fairfax, Virginia, 22031

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)

    Fargo, North Dakota, 58102

  • Altru Health System ( Site 0040)

    Grand Forks, North Dakota, 58201

  • Cancer and Hematology Centers of Western Michigan ( Site 4003)

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering - Westchester ( Site 4058)

    Harrison, New York, 10604

  • Edwards Comprehensive Cancer Center ( Site 4015)

    Huntington, West Virginia, 25701

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida ( Site 4043)

    Jacksonville, Florida, 32224

  • Thompson Cancer Survival Center ( Site 0097)

    Knoxville, Tennessee, 37916

  • NHO Revive Research Institute, LLC ( Site 4009)

    Lincoln, Nebraska, 68506

  • UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)

    Los Angeles, California, 90095

  • The University of Louisville, James Graham Brown Cancer Center ( Site 0037)

    Louisville, Kentucky, 40202

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)

    Marietta, Georgia, 30060

  • Baptist Cancer Center ( Site 4049)

    Memphis, Tennessee, 38120

  • Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)

    Miami, Florida, 33176

  • Memorial Sloan Kettering - Monmouth ( Site 4057)

    Middletown, New Jersey, 07748

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)

    Mineola, New York, 11501

  • Memorial Sloan Kettering - Bergen ( Site 4059)

    Montvale, New Jersey, 07645

  • Atlantic Health Morristown Medical Center ( Site 4018)

    Morristown, New Jersey, 07960

  • One Oncology - Tennessee Oncology ( Site 4019)

    Nashville, Tennessee, 37203

  • SCRI Oncology Partners ( Site 7001)

    Nashville, Tennessee, 37203

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center ( Site 0010)

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai ( Site 0034)

    New York, New York, 10029

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center ( Site 0029)

    New York, New York, 10065

  • Southeastern Regional Medical Center ( Site 0098)

    Newnan, Georgia, 30265

  • Hoag Memorial Hospital Presbyterian ( Site 4042)

    Newport Beach, California, 92663

  • Hoag Memorial Hospital Presbyterian ( Site 4048)

    Newport Beach, California, 92663

  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)

    Orange, California, 92868

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)

    Orange, California, 92868

  • Mid Florida Hematology and Oncology Center ( Site 0014)

    Orange City, Florida, 32763

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)

    Orlando, Florida, 32804

  • Illinois Cancer Care ( Site 7003)

    Peoria, Illinois, 61615

  • Thomas Jefferson University - Clinical Research Institute ( Site 0006)

    Philadelphia, Pennsylvania, 19107

  • Beacon Cancer Care ( Site 0044)

    Post Falls, Idaho, 83854

  • Swedish Medical Center-Swedish Cancer Institute ( Site 0088)

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center ( Site 0002)

    Seattle, Washington, 98109

  • Sanford Cancer Center ( Site 0075)

    Sioux Falls, South Dakota, 57104

  • Stony Brook University-Cancer Center ( Site 0072)

    Stony Brook, New York, 11794

  • Moffitt Cancer Center ( Site 0078)

    Tampa, Florida, 33612

  • Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)

    The Bronx, New York, 10461

  • The University of Arizona Cancer Center - North Campus ( Site 0071)

    Tucson, Arizona, 85719

  • Memorial Sloan Kettering - Nassau ( Site 4060)

    Uniondale, New York, 11553

  • George Washington University Medical Faculty Associates ( Site 4064)

    Washington D.C., District of Columbia, 20037

  • Novant Health Oncology Specialists ( Site 4045)

    Winston-Salem, North Carolina, 27103

  • YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)

    Yuma, Arizona, 85364

Other trials in United States

Japan11 sites

  • Hyogo Cancer Center ( Site 3809)

    Akashi, Hyōgo, 673-8558

  • Kansai Medical University Hospital ( Site 3806)

    Hirakata, Osaka, 573-1191

  • Hirosaki University Hospital ( Site 3808)

    Hirosaki, Aomori, 036-8563

  • Hiroshima University Hospital ( Site 3804)

    Hiroshima, 734-8551

  • National Cancer Center Hospital East ( Site 3800)

    Kashiwa, Chiba, 277-8577

  • St. Marianna University Hospital ( Site 3802)

    Kawasaki, Kanagawa, 216-8511

  • Nagoya University Hospital ( Site 3810)

    Nagoya, Aichi-ken, 466-8560

  • Okayama University Hospital ( Site 3807)

    Okayama, 700-8558

  • Kindai University Hospital ( Site 3803)

    Sakai, Osaka, 590-0197

  • Sendai Kousei Hospital ( Site 3805)

    Sendai, Miyagi, 981-0914

  • Kanagawa Cancer Center ( Site 3801)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Germany10 sites

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 1208)

    Berlin, 14165

  • Augusta-Kranken-Anstalt ( Site 1213)

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1201)

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Asklepios Klinik Gauting GmbH-Oncology ( Site 1209)

    Gauting, Bavaria, 82131

  • SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1200)

    Gera, Thuringia, 07548

  • LungenClinic Grosshansdorf-Onkologie ( Site 1203)

    Großhansdorf, Schleswig-Holstein, 22927

  • Klinikverbund Allgäu gGmbH ( Site 1205)

    Kempten (Allgäu), Bavaria, 87439

  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1202)

    Münster, North Rhine-Westphalia, 48153

  • Brüderkrankenhaus St. Josef Paderborn-Klinik für Hämatologie und Onkologie ( Site 1214)

    Paderborn, North Rhine-Westphalia, 33098

  • Universitaetsklinikum Regensburg ( Site 1204)

    Regensburg, Bavaria, 93053

Other trials in Germany

Italy10 sites

  • CRO-IRCCS-Clinical Oncology ( Site 1510)

    Aviano, Friuli Venezia Giulia, 33081

  • Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1507)

    Bari, Apulia, 70124

  • AOU Policlinico G. Rodolico - San Marco di Catania ( Site 1503)

    Catania, 95123

  • Azienda Ospedaliera Santa Croce e Carle ( Site 1500)

    Cuneo, 12100

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1504)

    Milan, Lombardy, 20133

  • ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 1511)

    Milan, Milano, 20162

  • A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1508)

    Naples, Napoli, 80131

  • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502)

    Novara, 28100

  • AO Santa Maria della Misericordia-Oncology Department ( Site 1501)

    Perugia, Umbria, 06132

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1506)

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Brazil9 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3004)

    Barretos, São Paulo, 14784400

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 3007)

    Fortaleza, Ceará, 60336232

  • Liga Norte Riograndense Contra o Câncer ( Site 3001)

    Natal, Rio Grande do Norte, 59062-000

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 3003)

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Nossa Senhora da Conceição ( Site 3002)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Câncer - INCA ( Site 3000)

    Rio de Janeiro, 20230-130

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3013)

    São José do Rio Preto, São Paulo, 15090000

  • Hospital Samaritano De Sao Paulo ( Site 3006)

    São Paulo, 01232-010

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3005)

    São Paulo, 01246-000

Other trials in Brazil

Mexico9 sites

  • Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 3402)

    Chihuahua City, 31123

  • Mediadvance Clinical ( Site 3404)

    Chihuahua City, 31203

  • Arké SMO S.A. de C.V. ( Site 3415)

    Distrito Federal, 6700

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 3403)

    Guadalajara, Jalisco, 44630

  • Clinica Oncologica Especializada ( Site 3410)

    Mexico City, Mexico City, 3240

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 3408)

    Monterrey, Nuevo León, 66460

  • Oaxaca Site Management Organization S.C. ( Site 3407)

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca ( Site 3401)

    Oaxaca City, 68020

  • Grupo Ollin Care ( Site 3414)

    Pachuca, Hidalgo, 42000

Other trials in Mexico

France8 sites

  • Institut de Cancérologie de l'Ouest ( Site 1101)

    Angers, Maine-et-Loire, 49055

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1107)

    Caen, Calvados, 14000

  • CHU GABRIEL MONTPIED ( Site 1105)

    Clermont-Ferrand, Puy-de-Dome, 63000

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 1108)

    Marseille, Bouches-du-Rhone, 13915

  • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)

    Montpellier, Herault, 34090

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1104)

    Paris, 75014

  • CHU Bordeaux Haut-Leveque ( Site 1106)

    Pessac, Aquitaine, 33600

  • Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100)

    Strasbourg, Alsace, 67091

Other trials in France

Poland8 sites

  • Bialostockie Centrum Onkologii ( Site 2005)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2003)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Uniwersyteckie Centrum Kliniczne ( Site 2013)

    Gdansk, Pomeranian Voivodeship, 80-952

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddział Kliniczny Chirurgii Klatki Piersiowej i ( Site 2011)

    Krakow, Lesser Poland Voivodeship, 30-002

  • Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2008)

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2002)

    Poznan, Greater Poland Voivodeship, 60-569

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

South Korea8 sites

  • Chungbuk National University Hospital-Internal medicine ( Site 0402)

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 0407)

    Daegu, Taegu-Kwangyokshi, 42601

  • National Cancer Center-Lung Cancer Center ( Site 0403)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Bundang Hospital-Medical Oncology ( Site 0404)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 0400)

    Seoul, 03080

  • Asan Medical Center-Department of Oncology ( Site 0405)

    Seoul, 05505

  • Samsung Medical Center ( Site 0401)

    Seoul, 06351

  • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 0406)

    Suwon, Kyonggi-do, 16247

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital ( Site 0504)

    Changhua, 50006

  • National Taiwan University Hospital - Hsinchu branch ( Site 0501)

    Hsinchu, 300

  • Taichung Veterans General Hospital-Chest ( Site 0503)

    Taichung, 40705

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505)

    Tainan, 704

  • National Taiwan University Hospital-Oncology ( Site 0506)

    Taipei, 10002

  • Taipei Medical University Hospital ( Site 0502)

    Taipei, 110301

  • National Taiwan University Cancer Center (NTUCC) ( Site 0500)

    Taipei City, Taipei, 106

Other trials in Taiwan

Turkey (Türkiye)7 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2103)

    Ankara, 06520

  • Liv Hospital Ankara-Oncology ( Site 2104)

    Ankara, 06680

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)

    Ankara, 06800

  • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2107)

    Bornova, İzmir, 35100

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2102)

    Istanbul, 34722

  • Medipol Mega Universite Hastanesi-oncology ( Site 2105)

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Clinica Adventista Belgrano-Oncology ( Site 2901)

    Caba., Buenos Aires, C1430EGF

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

  • Instituto Alexander Fleming ( Site 2911)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)

    Mar del Plata, Buenos Aires, B7600FZO

  • Fundacion Estudios Clinicos-Oncology ( Site 2907)

    Rosario, Santa Fe Province, S2000DEJ

  • Sanatorio Parque ( Site 2904)

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Spain6 sites

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400)

    Barcelona, 08035

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403)

    Majadahonda, Madrid, Comunidad de, 28222

  • Hospital Quirón Málaga ( Site 2405)

    Málaga, Malaga, 29004

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404)

    Seville, 41009

Other trials in Spain

Canada5 sites

  • William Osler Health System ( Site 0101)

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute ( Site 0105)

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de l'Université de Montréal ( Site 0104)

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre ( Site 0100)

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre ( Site 0102)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Chile5 sites

  • Orlandi Oncologia-Oncology ( Site 3102)

    Santiago, Region M. de Santiago, 7500713

  • FALP-UIDO ( Site 3100)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 3104)

    Santiago, Region M. de Santiago, 832000

  • Bradfordhill-Clinical Area ( Site 3103)

    Santiago, Region M. de Santiago, 8420383

  • ONCOCENTRO APYS ( Site 3105)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Hungary5 sites

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz - Pulmonologia Osztaly ( Site 1404)

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz -Onkologiai Kozpont ( Site 1407)

    Kaposvár, Somogy County, 7400

  • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401)

    Kecskemét, Bács-Kiskun county, 6000

  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402)

    Pécs, Baranya, 7624

  • Reformatus Pulmonologiai Centrum ( Site 1405)

    Törökbálint, Pest County, 2045

Other trials in Hungary

Malaysia5 sites

  • Hospital Pulau Pinang ( Site 3505)

    George Town, Pulau Pinang, 10450

  • Hospital Tengku Ampuan Afzan ( Site 3504)

    Kuantan, Pahang, 25100

  • Sarawak General Hospital ( Site 3500)

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre ( Site 3502)

    Lembah Pantai, Kuala Lumpur, 59100

  • National Cancer Institute-Radiotherapy and Oncology ( Site 3506)

    Putrajaya, Kuala Lumpur, 62250

Other trials in Malaysia

Belgium4 sites

  • AZORG Campus Aalst-Moorselbaan ( Site 0604)

    Aalst, Oost-Vlaanderen, 9300

  • Antwerp University Hospital-Thoracic Oncology ( Site 0603)

    Edegem, Antwerpen, 2650

  • VITAZ ( Site 0600)

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 0602)

    Yvoir, Namur, 5530

Other trials in Belgium

Czechia4 sites

  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0700)

    Brno, Brno-mesto, 656 53

  • Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0701)

    Olomouc, 779 00

  • Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 0702)

    Ostrava, Ostrava Mesto, 703 00

  • Vseobecna fakultni nemocnice v Praze ( Site 0703)

    Prague, 12808

Other trials in Czechia

Finland4 sites

  • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 1003)

    Oulu, North Ostrobothnia, 90220

  • Tampereen yliopistollinen sairaala-Oncology ( Site 1001)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 1000)

    Turku, Southwest Finland, 20520

  • Vaasan Keskussairaala-Department of Clinical Oncology ( Site 1004)

    Vaasa, Pohjanmaa, 65130

Other trials in Finland

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 2202)

    Banská Bystrica, Banská Bystrica Region, 97517

  • Univerzitná nemocnica Bratislava - Nemocnica Ružinov ( Site 2201)

    Bratislava, Bratislava Region, 826 06

  • Nemocnica BORY a. s. ( Site 2205)

    Bratislava, Bratislava Region, 841 03

  • Vychodoslovensky Onkologicky ustav a.s. ( Site 2200)

    Košice, Košice Region, 041 91

Other trials in Slovakia

Australia3 sites

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203)

    Melbourne, Victoria, 3000

  • St Vincent's Hospital-Oncology Clinical Trials ( Site 0202)

    Melbourne, Victoria, 3065

  • One Clinical Research ( Site 0200)

    Nedlands, Western Australia, 6009

Other trials in Australia

Greece3 sites

  • Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 1301)

    Athens, Attica, 115 26

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1300)

    Athens, Attica, 115 27

  • European Interbalkan Medical Center-Oncology Department ( Site 1302)

    Thessaloniki, 570 01

Other trials in Greece

Norway3 sites

  • Drammen Sykehus, Vestre Viken HF ( Site 1903)

    Drammen, Buskerud, 3004

  • Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900)

    Lørenskog, Akershus, 1478

  • Stavanger Universitetssykehus ( Site 1901)

    Stavanger, Rogaland, 4011

Other trials in Norway

Philippines3 sites

  • Metro Davao Medical and Research Center ( Site 3602)

    Davao City, Davao Del Sur, 8000

  • ST. LUKE'S MEDICAL CENTER ( Site 3606)

    Quezon City, National Capital Region, 1102

  • CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3601)

    San Juan City, Metro Manila, National Capital Region, 1502

Other trials in Philippines

Costa Rica2 sites

  • CIMCA ( Site 3300)

    San José, Provincia de San José, 10103

  • ICIMED ( Site 3301)

    San José, 10108

Other trials in Costa Rica

Denmark2 sites

  • Rigshospitalet ( Site 0801)

    Copenhagen, Capital Region, 2100

  • Odense Universitetshospital ( Site 0800)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Estonia2 sites

  • North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901)

    Tallinn, Harju, 13419

  • Tartu University Hospital-Radiotherapy and oncology ( Site 0900)

    Tartu, Tartu, 50406

Other trials in Estonia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701)

    Kaunas, Kaunas County, 50161

  • Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 1700)

    Vilnius, LT-08406

Other trials in Lithuania

New Zealand2 sites

  • Harbour Cancer & Wellness ( Site 0301)

    Auckland, 1023

  • New Zealand Clinical Research (Christchurch) ( Site 0300)

    Christchurch, Canterbury, 8011

Other trials in New Zealand

Portugal2 sites

  • Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)

    Lisbon, Lisbon District, 1769-001

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)

    Porto, 4200-072

Other trials in Portugal

Ireland1 site

  • Tallaght University Hospital ( Site 3903)

    Dublin, D24 NR0A

Other trials in Ireland

Latvia1 site

  • RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia ( Site 1600)

    Riga, LV1079

Other trials in Latvia

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Being tested
Intismeran autogene, Pembrolizumab, 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.

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • PlaceboOther

    IM injection

Study groups in NCT06077760
Study groupRoleWhat they receive
Intismeran autogene + PembrolizumabExperimentalParticipants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Receives: Biological: Intismeran autogene; Biological: Pembrolizumab
Placebo + PembrolizumabActive comparatorParticipants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Receives: Biological: Pembrolizumab; Other: Placebo

What is being measured

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

  1. Disease- Free Survival (DFS)

    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.

    Measured: Up to ~78 months

Secondary outcomes (11)

  1. Overall Survival (OS)

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

    Measured: Up to ~12 years

  2. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first.

    Measured: Up to ~12 years

  3. Lung Cancer Specific Survival (LCSS)

    LCSS is defined as the time from randomization to death due to lung cancer.

    Measured: Up to ~12 years

  4. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. 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 ~12 years

  5. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.

    Measured: Baseline and up to ~12 years

  6. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life 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. Higher scores indicate 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 ~12 years

  7. Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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. Higher scores indicate a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.

    Measured: Baseline and up to ~12 years

  8. Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24

    The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to questions about coughing 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 more coughing. The change from baseline in coughing (EORTC QLQ-LC24 Items 31 and 52) combined score will be presented.

    Measured: Baseline and up to ~12 years

  9. Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24

    The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 more chest pain. The change from baseline in chest pain (EORTC QLQ-LC24 Item 40) score will be presented.

    Measured: Baseline and up to ~12 years

  10. Number of Participants Who Experience an Adverse Event (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.

    Measured: Up to ~15 months

  11. 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.

    Measured: Up to ~12 months

Timeline

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

  1. First posted11 Oct 2023
  2. Study start6 Dec 2023
  3. Primary completion25 Jun 2030 (estimated)
  4. Study completion21 Dec 2035 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
868 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077760
Sponsor's protocol ID
V940-002
Other IDs
2023-504923-20-00, U1111-1290-3969, jRCT2061240063, PHRR240705-007252, 2023
Acronym
INTerpath-002
Status last verified
Sep 2026
First submitted
5 Oct 2023
Last updated
18 Sep 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 autogene and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 229 sites in 33 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 14 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Japan, Germany, Italy, Brazil and 28 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease- Free Survival (DFS) (time frame: Up to ~78 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 NCT06077760.

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 18 Sep 2026.

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