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
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
• Measurable disease as assessed by the local site investigator/radiology.
Locations
United States
California
Providence Medical Foundation ( Site 0117)
RECRUITING
Fullerton
Illinois
Illinois Cancer Care ( Site 0101)
RECRUITING
Peoria
New York
Montefiore Medical Center ( Site 0104)
RECRUITING
The Bronx
Ohio
University of Cincinnati Medical Center ( Site 0112)
RECRUITING
Cincinnati
Other Locations
China
Beijing Peking Union Medical College Hospital ( Site 5000)
RECRUITING
Beijing
Jilin Province Tumor Hospital ( Site 5014)
RECRUITING
Changchun
Sichuan Cancer Hospital. ( Site 5006)
RECRUITING
Chengdu
West China Hospital of Sichuan University ( Site 5016)
RECRUITING
Chengdu
Chongqing University Three Gorges Hospital ( Site 5018)
RECRUITING
Chongqing
Fujian Province Cancer Hospital ( Site 5007)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital ( Site 5003)
RECRUITING
Guangzhou
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
RECRUITING
Hangzhou
Huizhou Central People's Hospital ( Site 5004)
RECRUITING
Huizhou
Jiangmen Center Hospital ( Site 5001)
RECRUITING
Jiangmen
Jinan Central Hospital ( Site 5012)
RECRUITING
Jinan
Taizhou Hospital of Zhejiang Province ( Site 5002)
RECRUITING
Linhai
Liuzhou People's Hospital ( Site 5009)
RECRUITING
Liuzhou
The First Affiliated Hospital of Nanchang University ( Site 5019)
RECRUITING
Nanchang
Shanghai Pulmonary Hospital ( Site 5010)
RECRUITING
Shanghai
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
RECRUITING
Wuhan
The First Affiliated hospital of Xiamen University ( Site 5008)
RECRUITING
Xiamen
Germany
Universitätsklinikum Jena ( Site 2002)
RECRUITING
Jena
Guatemala
CELAN,S.A ( Site 1104)
RECRUITING
Guatemala City
MEDI-K ( Site 1101)
RECRUITING
Guatemala City
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
RECRUITING
Guatemala City
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
RECRUITING
Quetzaltenango
Japan
Juntendo University Hospital ( Site 4003)
RECRUITING
Bunkyo
Saitama Prefectural Cancer Center ( Site 4001)
RECRUITING
Kitaadachi-gun
Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)
RECRUITING
Kitakyushu
Miyagi Cancer Center ( Site 4000)
RECRUITING
Natori-shi
Osaka International Cancer Institute ( Site 4005)
RECRUITING
Osaka
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
RECRUITING
Sakai
Takarazuka City Hospital ( Site 4006)
RECRUITING
Takarazuka
Ehime University Hospital ( Site 4007)
RECRUITING
Tōon
Fujita Health University Hospital ( Site 4004)
RECRUITING
Toyoake
Tochigi Cancer Center ( Site 4008)
RECRUITING
Utsunomiya
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
RECRUITING
Yokohama
Peru
Clínica Internacional - Sede San Borja ( Site 1002)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
RECRUITING
Lima
Oncosalud ( Site 1000)
RECRUITING
Lima
Clínica San Antonio ( Site 1006)
RECRUITING
Trujillo
Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
RECRUITING
Siedlce
Narodowy Instytut Onkologii ( Site 2303)
RECRUITING
Warsaw
Republic of Korea
Chungnam National University Hospital ( Site 3003)
RECRUITING
Daejeon
Pusan National University Hospital ( Site 3002)
RECRUITING
Pusan Kwangyokshi
Korea University Guro Hospital ( Site 3001)
RECRUITING
Seoul
Romania
Institutul Oncologic ( Site 2202)
RECRUITING
Cluj-napoca
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL ( Site 2203)
RECRUITING
Floreşti
Spitalul Municipal Schuller Ploiești ( Site 2204)
RECRUITING
Ploieşti
Spain
Hospital General Universitari Vall d Hebron ( Site 2450)
RECRUITING
Barcelona
INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
RECRUITING
Barcelona
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
RECRUITING
Donostia / San Sebastian
Hospital Universitario Juan Ramon Jimenez ( Site 2453)
RECRUITING
Huelva
Hospital Universitario Virgen Macarena ( Site 2455)
RECRUITING
Seville
Turkey
Ankara Bilkent Sehir Hastanesi ( Site 2503)
RECRUITING
Ankara
Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
RECRUITING
Ankara
Gulhane Egitim Arastirma Hastanesi ( Site 2504)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
RECRUITING
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
RECRUITING
Bornova
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
RECRUITING
Istanbul
United Kingdom
Torbay Hospital ( Site 2100)
RECRUITING
Torquay
The Royal Cornwall Hospital ( Site 2102)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2030-02-11
Participants
Target number of participants: 160
Treatments
Experimental: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Active_comparator: Pembrolizumab
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course,
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC