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ACTIVE NOT RECRUITING
NCT06698042
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

Administered subcutaneously on Day 1 of each cycle

BIOLOGICAL

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