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Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
Official title: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
611
Start Date
2022-05-03
Completion Date
2026-08-19
Last Updated
2025-08-01
Healthy Volunteers
No
Conditions
Interventions
pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion
durvalumab
Administered as an IV infusion
cisplatin
Cisplatin 75 mg/m\^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m\^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3
pemetrexed
Pemetrexed 500 mg/m\^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only
etoposide
Etoposide 50 mg/m\^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3;
carboplatin
Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
paclitaxel
Paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
thoracic radiotherapy
60 Gray \[Gy\] in 2 Gy fractions for 30 days total administered as an external beam radiation
Locations (160)
VA Long Beach Healthcare System ( Site 2831)
Long Beach, California, United States
VA West Los Angeles Medical Center ( Site 2808)
Los Angeles, California, United States
Millennium Oncology Research Clinic ( Site 2801)
Hollywood, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 2800)
Orange City, Florida, United States
Moffitt Cancer Center ( Site 2818)
Tampa, Florida, United States
University of Chicago Medical Center ( Site 2828)
Chicago, Illinois, United States
Franciscan St. Francis Health ( Site 2812)
Indianapolis, Indiana, United States
MFSMC-HJWCI ( Site 2804)
Baltimore, Maryland, United States
Boston Medical Center ( Site 2829)
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School ( Site 2815)
Worcester, Massachusetts, United States
University of Missouri Hospital ( Site 2839)
Columbia, Missouri, United States
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)
Springfield, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 2805)
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai ( Site 2821)
New York, New York, United States
White Plains Hospital ( Site 2835)
White Plains, New York, United States
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)
Portland, Oregon, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)
Lancaster, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute ( Site 2813)
Philadelphia, Pennsylvania, United States
Millennium Research & Clinical Development ( Site 2811)
Houston, Texas, United States
Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
Temple, Texas, United States
MultiCare Health System ( Site 2817)
Tacoma, Washington, United States
Clinica Adventista Belgrano ( Site 3601)
Caba., Buenos Aires F.D., Argentina
Instituto Médico Río Cuarto ( Site 3600)
Río Cuarto, Córdoba Province, Argentina
Sanatorio Parque ( Site 3602)
Rosario, Santa Fe Province, Argentina
Canberra Hospital ( Site 0010)
Canberra, Australian Capital Territory, Australia
Icon Cancer Centre Hobart ( Site 0003)
Hobart, Tasmania, Australia
Ballarat Health Services-Medical Oncology ( Site 0002)
Ballarat Central, Victoria, Australia
Frankston Hospital-Oncology and Haematology ( Site 0009)
Frankston, Victoria, Australia
St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)
Melbourne, Victoria, Australia
Hospital Nossa Senhora da Conceição ( Site 0111)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)
Rio de Janeiro, Brazil
A. C. Camargo Cancer Center-CAPEC ( Site 0102)
São Paulo, Brazil
FALP-UIDO ( Site 0205)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0209)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0200)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0202)
Temuco, Región de la Araucanía, Chile
ONCOCENTRO APYS-ACEREY ( Site 0203)
Viña del Mar, Región de Valparaíso, Chile
Biocenter ( Site 0208)
Concepción, Región del Biobío, Chile
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)
Beijing, Beijing Municipality, China
Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)
Beijing, Beijing Municipality, China
Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 0316)
Fuzhou, Fujian, China
Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)
Fuzhou Fujian, Fujian, China
The First Affiliated hospital of Xiamen University-oncology ( Site 0317)
Xiamen, Fujian, China
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)
Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University ( Site 0331)
Shijiazhuang, Hebei, China
Henan Cancer Hospital ( Site 0333)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0315)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0311)
Wuhan, Hubei, China
Xiangya Hospital Central South University-Oncology department ( Site 0310)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0307)
Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University ( Site 0314)
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University ( Site 0305)
Zhenjiang, Jiangsu, China
Jilin Cancer Hospital-oncology department ( Site 0319)
Changchun, Jilin, China
Shandong Provincial Hospital ( Site 0326)
Jinan, Shandong, China
Qingdao Central Hospital-Endocrinology ( Site 0332)
Qingdao, Shandong, China
Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 0304)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital-Pulmonology ( Site 0322)
Taiyuan, Shanxi, China
West China Hospital of Sichuan University ( Site 0324)
Chengdu, Sichuan, China
Tianjin Cancer Hospital ( Site 0329)
Tianjin, Tianjin Municipality, China
Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)
Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0308)
Hangzhou, Zhejiang, China
CIMCA ( Site 0501)
San José, Provincia de San José, Costa Rica
PROCLINICAL Pharma ( Site 0504)
San José, Provincia de San José, Costa Rica
Hospital Metropolitano - Sede Lindora ( Site 0503)
Santa Ana, Provincia de San José, Costa Rica
Masarykuv onkologicky ustav ( Site 3500)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 3502)
Ostrava, Moravskoslezský kraj, Czechia
Instituto de Oncologia ( Site 3003)
Santo Domingo, Nacional, Dominican Republic
Onconet ( Site 3002)
Distrito Nacional, Santo Domingo Province, Dominican Republic
Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)
Chemnitz, Saxony, Germany
LungenClinic Grosshansdorf-Onkologie ( Site 0602)
Großhansdorf, Schleswig-Holstein, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo ( Site 0609)
Kiel, Schleswig-Holstein, Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603)
Berlin, Germany
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)
Athens, Attica, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)
Athens, Attica, Greece
Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)
Athens, Attica, Greece
Metropolitan Hospital ( Site 0702)
Athens, Attica, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 0705)
Nea Kifissia, Attica, Greece
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)
Heraklion, Irakleio, Greece
European Interbalkan Medical Center ( Site 0701)
Thessaloniki, Greece
MEDI-K ( Site 0807)
Guatemala City, Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)
Guatemala City, Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 0801)
Quetzaltenango, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)
Quetzaltenango, Guatemala
Rambam Health Care Campus-Oncology ( Site 1001)
Haifa, Israel
Shaare Zedek Medical Center ( Site 1003)
Jerusalem, Israel
Rabin Medical Center ( Site 1004)
Petah Tikva, Israel
Sheba Medical Center-ONCOLOGY ( Site 1000)
Ramat Gan, Israel
Sourasky Medical Center ( Site 1002)
Tel Aviv, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)
Naples, Campania, Italy
Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)
Milan, Lombardy, Italy
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)
Monza, Lombardy, Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)
Brescia, Italy
Ospedale San Raffaele. ( Site 1104)
Milan, Italy
Fondazione IRCCS Policlinico San Matteo ( Site 1103)
Pavia, Italy
National Hospital Organization Shikoku Cancer Center ( Site 1211)
Matsuyama, Ehime, Japan
Kurume University Hospital ( Site 1212)
Kurume, Fukuoka, Japan
Kobe Minimally Invasive Cancer Center ( Site 1210)
Kobe, Hyōgo, Japan
Kanagawa Cancer Center ( Site 1204)
Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 1200)
Natori-shi, Miyagi, Japan
Sendai Kousei Hospital ( Site 1213)
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 1205)
Niigata, Niigata, Japan
Kansai Medical University Hospital ( Site 1207)
Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 1208)
Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 1201)
Ina-machi, Saitama, Japan
Cancer Institute Hospital of JFCR ( Site 1202)
Koto, Tokyo, Japan
Showa Medical University Hospital ( Site 1203)
Shinagawa, Tokyo, Japan
Osaka International Cancer Institute ( Site 1209)
Osaka, Japan
University Malaya Medical Centre-Clinical Oncology ( Site 1402)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 1400)
George Town, Pulau Pinang, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)
Kuala Lumpur, Malaysia
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)
Guadalajara, Jalisco, Mexico
Arké SMO S.A. de C.V. ( Site 1504)
Mexico City, Mexico City, Mexico
Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)
Chihuahua City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1501)
Oaxaca City, Mexico
THE MEDICAL CITY-Cancer Research Center ( Site 3200)
Pasig, National Capital Region, Philippines
Veterans Memorial Medical Center-Section of Oncology ( Site 3201)
Quezon City, National Capital Region, Philippines
Champalimaud Foundation ( Site 2003)
Lisbon, Lisbon District, Portugal
Hospital CUF Descobertas ( Site 2006)
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2004)
Porto, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)
Porto, Portugal
Centrul Medical Medicover Victoria ( Site 2106)
Bucharest, București, Romania
Amethyst Radiotherapy Center ( Site 2102)
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)
Craiova, Dolj, Romania
Radiology Therapeutic Center ( Site 2108)
Otopeni, Ilfov, Romania
Cabinet Medical Oncomed ( Site 2101)
Timișoara, Timiș County, Romania
Centrul Medical Neolife- Baneasa ( Site 2110)
Bucharest, Romania
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)
Port Elizabeth, Eastern Cape, South Africa
Wilgers Oncology Centre ( Site 2301)
Pretoria, Gauteng, South Africa
The Oncology Centre ( Site 2300)
Durban, KwaZulu-Natal, South Africa
Abraham Oncology ( Site 2303)
Richards Bay, KwaZulu-Natal, South Africa
Cape Town Oncology Trials ( Site 2306)
Cape Town, Western Cape, South Africa
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
Suwon, Kyonggi-do, South Korea
Ajou University Hospital-Hematology-Oncology ( Site 2402)
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital-Internal medicine ( Site 2400)
Cheongju-si, North Chungcheong, South Korea
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)
Seoul, South Korea
Hospital Universitari Vall d'Hebron ( Site 2501)
Barcelona, Catalonia, Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2503)
Barcelona, Catalonia, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)
Santiago de Compostela, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)
Pozuelo de Alarcón, Madrid, Comunidad de, Spain
Medipol Mega Universite Hastanesi-oncology ( Site 2611)
Stanbul, Istanbul, Turkey (Türkiye)
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)
Bornova, İzmir, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)
Adana, Turkey (Türkiye)
Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)
Ankara, Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 2605)
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)
Ankara, Turkey (Türkiye)
Ankara City Hospital-Medical Oncology ( Site 2601)
Ankara, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)
Istanbul, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)
Izmir, Turkey (Türkiye)
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 2905)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital ( Site 2920)
Lviv, Lviv Oblast, Ukraine
Rivne Regional Clinical Hospital ( Site 2919)
Rivne, Rivne Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2900)
Vinnytsia, Vinnytsia Oblast, Ukraine
Volyn Regional clinical hospital. Regional Medical Oncology Centre. Oncology chemotherapy department ( Site 2918)
Lutsk, Volyn Oblast, Ukraine
Universal Clinic Oberig-Oncology Center ( Site 2916)
Kyiv, Ukraine