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A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Official title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2024-11-21
Completion Date
2030-02-11
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab (+) Berahyaluronidase alfa
Administered subcutaneously on Day 1 of each cycle
Pembrolizumab
Administered intravenously on Day 1 of each cycle
Locations (67)
Providence Medical Foundation ( Site 0117)
Fullerton, California, United States
Illinois Cancer Care ( Site 0101)
Peoria, Illinois, United States
Montefiore Medical Center ( Site 0104)
The Bronx, New York, United States
University of Cincinnati Medical Center ( Site 0112)
Cincinnati, Ohio, United States
Beijing Peking Union Medical College Hospital ( Site 5000)
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital ( Site 5018)
Chongqing, Chongqing Municipality, China
Fujian Province Cancer Hospital ( Site 5007)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 5008)
Xiamen, Fujian, China
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 5003)
Guangzhou, Guangdong, China
Huizhou Central People's Hospital ( Site 5004)
Huizhou, Guangdong, China
Jiangmen Center Hospital ( Site 5001)
Jiangmen, Guangdong, China
Liuzhou People's Hospital ( Site 5009)
Liuchow, Guangxi, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University ( Site 5019)
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital ( Site 5014)
Changchun, Jilin, China
Jinan Central Hospital ( Site 5012)
Jinan, Shandong, China
Shanghai Pulmonary Hospital ( Site 5010)
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University ( Site 5016)
Chengdu, Sichuan, China
Sichuan Cancer Hospital. ( Site 5006)
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 5002)
Linhai, Zhejiang, China
HELIOS Klinikum Erfurt ( Site 2005)
Erfurt, Thuringia, Germany
Universitätsklinikum Jena ( Site 2002)
Jena, Thuringia, Germany
MEDI-K ( Site 1101)
Guatemala City, Guatemala
CELAN,S.A ( Site 1104)
Guatemala City, Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
Guatemala City, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
Quetzaltenango, Guatemala
Fujita Health University Hospital ( Site 4004)
Toyoake, Aichi-ken, Japan
Ehime University Hospital ( Site 4007)
Tōon, Ehime, Japan
Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)
Kitakyushu, Fukuoka, Japan
Takarazuka City Hospital ( Site 4006)
Takarazuka, Hyōgo, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital ( Site 4012)
Nankoku, Kochi, Japan
Miyagi Cancer Center ( Site 4000)
Natori-shi, Miyagi, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
Sakai, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 4001)
Kitaadachi-gun, Saitama, Japan
Tochigi Cancer Center ( Site 4008)
Utsunomiya, Tochigi, Japan
Juntendo University Hospital ( Site 4003)
Bunkyo, Tokyo, Japan
Fukushima Medical University Hospital ( Site 4011)
Fukushima, Japan
Osaka International Cancer Institute ( Site 4005)
Osaka, Japan
Clínica San Antonio ( Site 1006)
Trujillo, La Libertad, Peru
Clínica Internacional - Sede San Borja ( Site 1002)
Lima, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
Lima, Peru
Oncosalud ( Site 1000)
Lima, Peru
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii ( Site 2303)
Warsaw, Masovian Voivodeship, Poland
SC Radiotherapy Center Cluj SRL ( Site 2203)
Floreşti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
Craiova, Dolj, Romania
Spitalul Municipal Schuller Ploiești ( Site 2204)
Ploieşti, Prahova, Romania
Institutul Oncologic ( Site 2202)
Cluj-Napoca, Romania
Pusan National University Hospital ( Site 3002)
Pusan Kwangyokshi, Pusan-Kwangyokshi, South Korea
Chungnam National University Hospital ( Site 3003)
Daejeon, Taejon-Kwangyokshi, South Korea
Korea University Guro Hospital ( Site 3001)
Seoul, South Korea
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital General Universitari Vall d Hebron ( Site 2450)
Barcelona, Spain
INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
Barcelona, Spain
Hospital Universitario Juan Ramon Jimenez ( Site 2453)
Huelva, Spain
Hospital Universitario Virgen Macarena ( Site 2455)
Seville, Spain
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
Bornova, İzmir, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi ( Site 2504)
Ankara, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
Ankara, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 2503)
Ankara, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
Istanbul, Turkey (Türkiye)
Torbay Hospital ( Site 2100)
Torquay, England, United Kingdom
The Royal Cornwall Hospital ( Site 2102)
Truro, England, United Kingdom