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ACTIVE NOT RECRUITING
NCT05298423
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

pembrolizumab/vibostolimab

Administered as an intravenous (IV) infusion

BIOLOGICAL

durvalumab

Administered as an IV infusion

DRUG

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

DRUG

pemetrexed

Pemetrexed 500 mg/m\^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only

DRUG

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;

DRUG

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

DRUG

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

RADIATION

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