A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
INTerpath-002
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)
5 other identifiers
interventional
868
32 countries
227
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Dec 2023
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
December 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 21, 2035
May 4, 2026
May 1, 2026
6.6 years
October 5, 2023
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
Up to ~78 months
Secondary Outcomes (11)
Overall Survival (OS)
Up to ~12 years
Distant Metastasis-Free Survival (DMFS)
Up to ~12 years
Lung Cancer Specific Survival (LCSS)
Up to ~12 years
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
Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Baseline and up to ~12 years
- +6 more secondary outcomes
Study Arms (2)
Intismeran autogene + Pembrolizumab
EXPERIMENTALParticipants 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.
Placebo + Pembrolizumab
ACTIVE 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.
Interventions
IV infusion
IM injection
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- ModernaTX, Inc.collaborator
Study Sites (229)
Alaska Oncology and Hematology ( Site 0039)
Anchorage, Alaska, 99508, United States
The University of Arizona Cancer Center - North Campus ( Site 0071)
Tucson, Arizona, 85719, United States
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)
Yuma, Arizona, 85364, United States
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)
Los Angeles, California, 90095, United States
Hoag Memorial Hospital Presbyterian ( Site 4042)
Newport Beach, California, 92663, United States
Hoag Memorial Hospital Presbyterian ( Site 4048)
Newport Beach, California, 92663, United States
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)
Orange, California, 92868, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)
Orange, California, 92868, United States
UCHealth Memorial Hospital-Heme Onc ( Site 0052)
Colorado Springs, Colorado, 80909, United States
George Washington University Medical Faculty Associates ( Site 4064)
Washington D.C., District of Columbia, 20037, United States
Mayo Clinic Florida ( Site 4043)
Jacksonville, Florida, 32224, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)
Miami, Florida, 33176, United States
Mid Florida Hematology and Oncology Center ( Site 0014)
Orange City, Florida, 32763, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)
Orlando, Florida, 32804, United States
Moffitt Cancer Center ( Site 0078)
Tampa, Florida, 33612, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)
Marietta, Georgia, 30060, United States
Southeastern Regional Medical Center ( Site 0098)
Newnan, Georgia, 30265, United States
Beacon Cancer Care ( Site 0044)
Post Falls, Idaho, 83854, United States
Illinois Cancer Care ( Site 7003)
Peoria, Illinois, 61615, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)
Iowa City, Iowa, 52242, United States
Saint Elizabeth Healthcare ( Site 0092)
Edgewood, Kentucky, 41017, United States
The University of Louisville, James Graham Brown Cancer Center ( Site 0037)
Louisville, Kentucky, 40202, United States
LSU Health Baton Rouge North Clinic ( Site 4040)
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake RMC-Clinical Research ( Site 4050)
Baton Rouge, Louisiana, 70808, United States
University of Michigan Clinical Trials Office ( Site 0058)
Ann Arbor, Michigan, 48109, United States
Cancer and Hematology Centers of Western Michigan ( Site 4003)
Grand Rapids, Michigan, 49503, United States
St. Vincent Frontier Cancer Center ( Site 0043)
Billings, Montana, 59102, United States
NHO Revive Research Institute, LLC ( Site 4009)
Lincoln, Nebraska, 68506, United States
Memorial Sloan Kettering - Basking Ridge ( Site 4056)
Basking Ridge, New Jersey, 07920, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering - Monmouth ( Site 4057)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering - Bergen ( Site 4059)
Montvale, New Jersey, 07645, United States
Atlantic Health Morristown Medical Center ( Site 4018)
Morristown, New Jersey, 07960, United States
New York Oncology Hematology, P.C. ( Site 4012)
Albany, New York, 12206, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)
Commack, New York, 11725, United States
Memorial Sloan Kettering - Westchester ( Site 4058)
Harrison, New York, 10604, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)
Mineola, New York, 11501, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)
New York, New York, 10011, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0010)
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai ( Site 0034)
New York, New York, 10029, United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center ( Site 0029)
New York, New York, 10065, United States
Stony Brook University-Cancer Center ( Site 0072)
Stony Brook, New York, 11794, United States
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
The Bronx, New York, 10461, United States
Memorial Sloan Kettering - Nassau ( Site 4060)
Uniondale, New York, 11553, United States
Novant Health Weisiger Cancer Insititute ( Site 4052)
Charlotte, North Carolina, 28204, United States
Novant Health Oncology Specialists ( Site 4045)
Winston-Salem, North Carolina, 27103, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)
Fargo, North Dakota, 58102, United States
Altru Health System ( Site 0040)
Grand Forks, North Dakota, 58201, United States
Summa Health ( Site 4011)
Akron, Ohio, 44304, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)
Cincinnati, Ohio, 45220, United States
University Hospitals Cleveland Medical Center ( Site 0023)
Cleveland, Ohio, 44106, United States
OSU Brain and Spine Hospital ( Site 0016)
Columbus, Ohio, 43210, United States
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)
Corvallis, Oregon, 97330, United States
Thomas Jefferson University - Clinical Research Institute ( Site 0006)
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0050)
Charleston, South Carolina, 29425, United States
Sanford Cancer Center ( Site 0075)
Sioux Falls, South Dakota, 57104, United States
Greco-Hainsworth Centers for Research ( Site 4034)
Chattanooga, Tennessee, 37421, United States
Thompson Cancer Survival Center ( Site 0097)
Knoxville, Tennessee, 37916, United States
Baptist Cancer Center ( Site 4049)
Memphis, Tennessee, 38120, United States
One Oncology - Tennessee Oncology ( Site 4019)
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners ( Site 7001)
Nashville, Tennessee, 37203, United States
UT Southwestern Medical Center ( Site 0061)
Dallas, Texas, 75390, United States
Inova Schar Cancer Institute ( Site 0003)
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists (VCS) ( Site 4004)
Fairfax, Virginia, 22031, United States
Swedish Medical Center-Swedish Cancer Institute ( Site 0088)
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center ( Site 0002)
Seattle, Washington, 98109, United States
Edwards Comprehensive Cancer Center ( Site 4015)
Huntington, West Virginia, 25701, United States
Clinica Adventista Belgrano-Oncology ( Site 2901)
Caba., Buenos Aires, C1430EGF, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
Instituto Alexander Fleming ( Site 2911)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 2907)
Rosario, Santa Fe Province, S2000DEJ, Argentina
Sanatorio Parque ( Site 2904)
Rosario, Santa Fe Province, S2000DSV, Argentina
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203)
Melbourne, Victoria, 3000, Australia
St Vincent's Hospital-Oncology Clinical Trials ( Site 0202)
Melbourne, Victoria, 3065, Australia
One Clinical Research ( Site 0200)
Nedlands, Western Australia, 6009, Australia
Antwerp University Hospital-Thoracic Oncology ( Site 0603)
Edegem, Antwerpen, 2650, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 0602)
Yvoir, Namur, 5530, Belgium
AZORG Campus Aalst-Moorselbaan ( Site 0604)
Aalst, Oost-Vlaanderen, 9300, Belgium
VITAZ ( Site 0600)
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 3007)
Fortaleza, Ceará, 60336232, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 3001)
Natal, Rio Grande do Norte, 59062-000, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 3003)
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Nossa Senhora da Conceição ( Site 3002)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3004)
Barretos, São Paulo, 14784400, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3013)
São José do Rio Preto, São Paulo, 15090000, Brazil
Instituto Nacional de Câncer - INCA ( Site 3000)
Rio de Janeiro, 20230-130, Brazil
Hospital Samaritano De Sao Paulo ( Site 3006)
São Paulo, 01232-010, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3005)
São Paulo, 01246-000, Brazil
Cross Cancer Institute ( Site 0105)
Edmonton, Alberta, T6G 1Z2, Canada
William Osler Health System ( Site 0101)
Brampton, Ontario, L6R 3J7, Canada
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0104)
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre ( Site 0100)
Montreal, Quebec, H4A 3J1, Canada
Orlandi Oncologia-Oncology ( Site 3102)
Santiago, Region M. de Santiago, 7500713, Chile
FALP-UIDO ( Site 3100)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 3104)
Santiago, Region M. de Santiago, 832000, Chile
Bradfordhill-Clinical Area ( Site 3103)
Santiago, Region M. de Santiago, 8420383, Chile
ONCOCENTRO APYS ( Site 3105)
Viña del Mar, Valparaiso, 2520598, Chile
CIMCA ( Site 3300)
San José, Provincia de San José, 10103, Costa Rica
ICIMED ( Site 3301)
San José, 10108, Costa Rica
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0700)
Brno, Brno-mesto, 656 53, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 0702)
Ostrava, Ostrava Mesto, 703 00, Czechia
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0701)
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0703)
Prague, 12808, Czechia
Rigshospitalet ( Site 0801)
Copenhagen, Capital Region, 2100, Denmark
Odense Universitetshospital ( Site 0800)
Odense, Region Syddanmark, 5000, Denmark
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901)
Tallinn, Harju, 13419, Estonia
Tartu University Hospital-Radiotherapy and oncology ( Site 0900)
Tartu, Tartu, 50406, Estonia
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 1003)
Oulu, North Ostrobothnia, 90220, Finland
Tampereen yliopistollinen sairaala-Oncology ( Site 1001)
Tampere, Pirkanmaa, 33520, Finland
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 1004)
Vaasa, Pohjanmaa, 65130, Finland
Turku University Hospital-The Department of Pulmonary Medicine ( Site 1000)
Turku, Southwest Finland, 20520, Finland
Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100)
Strasbourg, Alsace, 67091, France
CHU Bordeaux Haut-Leveque ( Site 1106)
Pessac, Aquitaine, 33600, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 1108)
Marseille, Bouches-du-Rhone, 13915, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1107)
Caen, Calvados, 14000, France
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)
Montpellier, Herault, 34090, France
Institut de Cancérologie de l'Ouest ( Site 1101)
Angers, Maine-et-Loire, 49055, France
CHU GABRIEL MONTPIED ( Site 1105)
Clermont-Ferrand, Puy-de-Dome, 63000, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1104)
Paris, 75014, France
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1201)
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Asklepios Klinik Gauting GmbH-Oncology ( Site 1209)
Gauting, Bavaria, 82131, Germany
Klinikverbund Allgäu gGmbH ( Site 1205)
Kempten (Allgäu), Bavaria, 87439, Germany
Universitaetsklinikum Regensburg ( Site 1204)
Regensburg, Bavaria, 93053, Germany
Augusta-Kranken-Anstalt ( Site 1213)
Bochum, North Rhine-Westphalia, 44791, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1202)
Münster, North Rhine-Westphalia, 48153, Germany
Brüderkrankenhaus St. Josef Paderborn-Klinik für Hämatologie und Onkologie ( Site 1214)
Paderborn, North Rhine-Westphalia, 33098, Germany
LungenClinic Grosshansdorf-Onkologie ( Site 1203)
Großhansdorf, Schleswig-Holstein, 22927, Germany
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1200)
Gera, Thuringia, 07548, Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 1208)
Berlin, 14165, Germany
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 1301)
Athens, Attica, 115 26, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1300)
Athens, Attica, 115 27, Greece
European Interbalkan Medical Center-Oncology Department ( Site 1302)
Thessaloniki, 570 01, Greece
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402)
Pécs, Baranya, 7624, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401)
Kecskemét, Bács-Kiskun county, 6000, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz - Pulmonologia Osztaly ( Site 1404)
Győr, Győr-Moson-Sopron, 9024, Hungary
Reformatus Pulmonologiai Centrum ( Site 1405)
Törökbálint, Pest County, 2045, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz -Onkologiai Kozpont ( Site 1407)
Kaposvár, Somogy County, 7400, Hungary
Tallaght University Hospital ( Site 3903)
Dublin, D24 NR0A, Ireland
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1507)
Bari, Apulia, 70124, Italy
CRO-IRCCS-Clinical Oncology ( Site 1510)
Aviano, Friuli Venezia Giulia, 33081, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1506)
Udine, Friuli Venezia Giulia, 33100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1504)
Milan, Lombardy, 20133, Italy
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 1511)
Milan, Milano, 20162, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1508)
Naples, Napoli, 80131, Italy
POLICLINICO "G. RODOLICO"-UOC Oncologia Medica ( Site 1503)
Catania, Sicily, 95123, Italy
AO Santa Maria della Misericordia-Oncology Department ( Site 1501)
Perugia, Umbria, 06132, Italy
Azienda Ospedaliera Santa Croce e Carle ( Site 1500)
Cuneo, 12100, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502)
Novara, 28100, Italy
Nagoya University Hospital ( Site 3810)
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital ( Site 3808)
Hirosaki, Aomori, 036-8563, Japan
National Cancer Center Hospital East ( Site 3800)
Kashiwa, Chiba, 277-8577, Japan
Hyogo Cancer Center ( Site 3809)
Akashi, Hyōgo, 673-8558, Japan
St. Marianna University Hospital ( Site 3802)
Kawasaki, Kanagawa, 216-8511, Japan
Kanagawa Cancer Center ( Site 3801)
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital ( Site 3805)
Sendai, Miyagi, 981-0914, Japan
Kansai Medical University Hospital ( Site 3806)
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital ( Site 3803)
Sakai, Osaka, 590-0197, Japan
Hiroshima University Hospital ( Site 3804)
Hiroshima, 734-8551, Japan
Okayama University Hospital ( Site 3807)
Okayama, 700-8558, Japan
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia ( Site 1600)
Riga, LV1079, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701)
Kaunas, Kaunas County, 50161, Lithuania
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 1700)
Vilnius, LT-08406, Lithuania
University Malaya Medical Centre ( Site 3502)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
National Cancer Institute-Radiotherapy and Oncology ( Site 3506)
Putrajaya, Kuala Lumpur, 62250, Malaysia
Hospital Tengku Ampuan Afzan ( Site 3504)
Kuantan, Pahang, 25100, Malaysia
Hospital Pulau Pinang ( Site 3505)
George Town, Pulau Pinang, 10450, Malaysia
Sarawak General Hospital ( Site 3500)
Kuching, Sarawak, 93586, Malaysia
Grupo Ollin Care ( Site 3414)
Pachuca, Hidalgo, 42000, Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 3403)
Guadalajara, Jalisco, 44630, Mexico
Clinica Oncologica Especializada ( Site 3410)
Mexico City, Mexico City, 3240, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 3408)
Monterrey, Nuevo León, 66460, Mexico
Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 3402)
Chihuahua City, 31123, Mexico
Mediadvance Clinical ( Site 3404)
Chihuahua City, 31203, Mexico
Arké SMO S.A. de C.V. ( Site 3415)
Distrito Federal, 6700, Mexico
Oaxaca Site Management Organization S.C. ( Site 3407)
Oaxaca City, 68000, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 3401)
Oaxaca City, 68020, Mexico
New Zealand Clinical Research (Christchurch) ( Site 0300)
Christchurch, Canterbury, 8011, New Zealand
Harbour Cancer & Wellness ( Site 0301)
Auckland, 1023, New Zealand
Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900)
Lørenskog, Akershus, 1478, Norway
Drammen Sykehus, Vestre Viken HF ( Site 1903)
Drammen, Buskerud, 3004, Norway
Stavanger Universitetssykehus ( Site 1901)
Stavanger, Rogaland, 4011, Norway
Metro Davao Medical and Research Center ( Site 3602)
Davao City, Davao Del Sur, 8000, Philippines
ST. LUKE'S MEDICAL CENTER ( Site 3606)
Quezon City, National Capital Region, 1102, Philippines
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3601)
San Juan City, Metro Manila, National Capital Region, 1502, Philippines
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2002)
Poznan, Greater Poland Voivodeship, 60-569, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddział Kliniczny Chirurgii Klatki Piersiowej i ( Site 2011)
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
Warsaw, Masovian Voivodeship, 02-781, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Bialostockie Centrum Onkologii ( Site 2005)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Uniwersyteckie Centrum Kliniczne ( Site 2013)
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2008)
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)
Lisbon, Lisbon District, 1769-001, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
Porto, 4200-072, Portugal
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 2202)
Banská Bystrica, Banská Bystrica Region, 97517, Slovakia
Univerzitná nemocnica Bratislava - Nemocnica Ružinov ( Site 2201)
Bratislava, Bratislava Region, 826 06, Slovakia
Nemocnica BORY a. s. ( Site 2205)
Bratislava, Bratislava Region, 841 03, Slovakia
Vychodoslovensky Onkologicky ustav a.s. ( Site 2200)
Košice, Košice Region, 041 91, Slovakia
National Cancer Center-Lung Cancer Center ( Site 0403)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital-Medical Oncology ( Site 0404)
Seongnam, Kyonggi-do, 13620, South Korea
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 0406)
Suwon, Kyonggi-do, 16247, South Korea
Chungbuk National University Hospital-Internal medicine ( Site 0402)
Cheongju-si, North Chungcheong, 28644, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 0407)
Daegu, Taegu-Kwangyokshi, 42601, South Korea
Seoul National University Hospital ( Site 0400)
Seoul, 03080, South Korea
Asan Medical Center-Department of Oncology ( Site 0405)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 0401)
Seoul, 06351, South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402)
Pozuelo de Alarcón, Madrid, 28223, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403)
Majadahonda, Madrid, Comunidad de, 28222, Spain
Hospital Quirón Málaga ( Site 2405)
Málaga, Malaga, 29004, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400)
Barcelona, 08035, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404)
Seville, 41009, Spain
National Taiwan University Cancer Center (NTUCC) ( Site 0500)
Taipei City, Taipei, 106, Taiwan
Changhua Christian Hospital ( Site 0504)
Changhua, 50006, Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 0501)
Hsinchu, 300, Taiwan
Taichung Veterans General Hospital-Chest ( Site 0503)
Taichung, 40705, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505)
Tainan, 704, Taiwan
National Taiwan University Hospital-Oncology ( Site 0506)
Taipei, 10002, Taiwan
Taipei Medical University Hospital ( Site 0502)
Taipei, 110301, Taiwan
Medipol Mega Universite Hastanesi-oncology ( Site 2105)
Stanbul, Istanbul, 34214, Turkey (Türkiye)
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2107)
Bornova, İzmir, 35100, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2103)
Ankara, 06520, Turkey (Türkiye)
Liv Hospital Ankara-Oncology ( Site 2104)
Ankara, 06680, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)
Ankara, 06800, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2102)
Istanbul, 34722, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 11, 2023
Study Start
December 6, 2023
Primary Completion (Estimated)
June 25, 2030
Study Completion (Estimated)
December 21, 2035
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf