The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
Official Title: An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)
Study ID: NCT05609968
Brief Summary: The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Infirmary Cancer Care ( Site 0418), Mobile, Alabama, United States
Clermont Oncology Center ( Site 0421), Clermont, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417), Miami, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0416), Orange City, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407), Marietta, Georgia, United States
Our Lady of the Lake RMC ( Site 0424), Baton Rouge, Louisiana, United States
Henry Ford Hospital ( Site 0412), Detroit, Michigan, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425), Minneapolis, Minnesota, United States
White Plains Hospital-Center for Cancer Care ( Site 0403), White Plains, New York, United States
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408), Portland, Oregon, United States
Houston Methodist Hospital ( Site 0419), Houston, Texas, United States
Central Texas Veterans health care ( Site 0414), Temple, Texas, United States
Orange Hospital-Clinical Trials Unit ( Site 0600), Orange, New South Wales, Australia
Cancer Research SA-St Andrews Hospital ( Site 0603), Adelaide, South Australia, Australia
Frankston Hospital-Oncology and Haematology ( Site 0601), Frankston, Victoria, Australia
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320), Fortaleza, Ceara, Brazil
Hospital Tacchini ( Site 0322), Bento Goncalves, Rio Grande Do Sul, Brazil
Hospital da Cidade de Passo Fundo ( Site 0321), Passo Fundo, Rio Grande Do Sul, Brazil
Instituto de Oncologia Saint Gallen ( Site 0317), Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318), Barretos, Sao Paulo, Brazil
A. C. Camargo Cancer Center ( Site 0324), Sao Paulo, , Brazil
BC Cancer Abbotsford-Medical Oncology ( Site 0433), Abbotsford, British Columbia, Canada
Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435), Newmarket, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430), Greenfield Park, Quebec, Canada
St. Marys Hospital Center-Oncology ( Site 0434), Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431), Trois-Rivières, Quebec, Canada
Oncovida ( Site 0334), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332), Santiago, Region M. De Santiago, Chile
Second Affiliated hospital of Anhui Medical University ( Site 0126), Hefei, Anhui, China
Anhui Provincial Hospital ( Site 0136), Hefei, Anhui, China
Beijing Cancer hospital ( Site 0104), Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106), Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University ( Site 0105), Beijing, Beijing, China
Chongqing University Cancer Hospital-Medical Oncology ( Site 0130), Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 0131), Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 0132), Xiamen, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (, Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 0113), Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 0119), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 0127), Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0116), Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115), Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0107), Wuhan, Hubei, China
Xiangya Hospital Central South University ( Site 0124), Changsha, Hunan, China
The Second Xiangya Hospital of Central South University ( Site 0135), Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112, NanJing, Jiangsu, China
Nantong Tumor Hospital-Medical Oncology ( Site 0122), Nantong, Jiangsu, China
The First Affliated Hospital of Suzhou University ( Site 0114), Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 0134), Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 0117), Changchun, Jilin, China
Jilin Province Tumor Hospital ( Site 0118), Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133), Xi'an, Shaanxi, China
Jinan Central Hospital-oncology department ( Site 0121), Jinan, Shandong, China
LinYi Cancer Hospital ( Site 0120), Linyi, Shandong, China
Shanghai Chest Hospital ( Site 0101), Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center-Oncology ( Site 0102), Shanghai, Shanghai, China
Huashan Hospital, Fudan University ( Site 0103), Shanghai, Shanghai, China
West China Hospital of Sichuan University ( Site 0129), Cheng Du, Sichuan, China
Sichuan Cancer hospital ( Site 0128), Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University ( Site 0109), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0108), Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110), Hangzhou, Zhejiang, China
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621), Tallinn, Harjumaa, Estonia
Tartu University Hospital-Radiotherapy and oncology ( Site 0620), Tartu, Tartumaa, Estonia
Universitätsmedizin Mannheim ( Site 0654), Mannheim, Baden-Wurttemberg, Germany
Klinikum Kempten ( Site 0655), Kempten, Bayern, Germany
Klinikum Würzburg Mitte ( Site 0651), Wuerzburg, Bayern, Germany
Katholisches Klinikum Koblenz ( Site 0650), Koblenz, Rheinland-Pfalz, Germany
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657), Halle, Sachsen-Anhalt, Germany
Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- (, Berlin, , Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653), Berlin, , Germany
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141), Athens, Attiki, Greece
Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 014, Athens, Attiki, Greece
European Interbalkan Medical Center-Oncology Department ( Site 0142), Thessaloniki, , Greece
Shaare Zedek Medical Center-Oncology ( Site 0176), Jerusalem, , Israel
Meir Medical Center-oncology ( Site 0171), KfarSaba, , Israel
Rabin Medical Center-Oncology ( Site 0174), Petah Tikva, , Israel
Sourasky Medical Center-Oncology ( Site 0175), Tel Aviv, , Israel
Yitzhak Shamir Medical Center. ( Site 0179), Zerifin, , Israel
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677), Roma, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674), Bergamo, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673), Milan, Lombardia, Italy
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671), Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675), Firenze, Toscana, Italy
Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670), Peschiera del Garda, Verona, Italy
Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676), Parma, , Italy
Aichi Cancer Center Hospital ( Site 0018), Nagoya, Aichi, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0008), Matsuyama, Ehime, Japan
Kurume University Hospital ( Site 0014), Kurume, Fukuoka, Japan
Takarazuka City Hospital ( Site 0015), Takarazuka, Hyogo, Japan
Kanazawa University Hospital ( Site 0019), Kanazawa, Ishikawa, Japan
Kanagawa cancer center ( Site 0016), Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 0001), Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 0012), Sendai, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 0017), Niigata-shi, Niigata, Japan
Kurashiki Central Hospital ( Site 0011), Kurashiki, Okayama, Japan
Kansai Medical University Hospital ( Site 0005), Hirakata, Osaka, Japan
Kindai University Hospital- Osakasayama Campus ( Site 0013), Osaka-sayama, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 0002), Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 0004), Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0009), Fukuoka, , Japan
Kyushu University Hospital ( Site 0010), Fukuoka, , Japan
Okayama University Hospital ( Site 0007), Okayama, , Japan
Nippon Medical School Hospital ( Site 0003), Tokyo, , Japan
Wakayama Medical University Hospital ( Site 0006), Wakayama, , Japan
Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061), Hwasun, Jeonranamdo, Korea, Republic of
Pusan National University Yangsan Hospital ( Site 0060), Busan, Kyongsangnam-do, Korea, Republic of
Chungnam national university hospital-Department of Internal Medicine ( Site 0063), Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Asan Medical Center ( Site 0064), Seoul, , Korea, Republic of
Korea University Guro Hospital-Internal Medicine ( Site 0062), Seoul, , Korea, Republic of
Daugavpils Regional Hospital-Oncology Department ( Site 0194), Daugavpils, Daugavpils Novads, Latvia
Liepjas reionl slimnca ( Site 0191), Liepaja, , Latvia
Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192), Riga, , Latvia
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch, Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692), Kaunas, Kauno Apskritis, Lithuania
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 0691), Vilnius, Vilniaus Miestas, Lithuania
Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035), Kota Bharu, Kelantan, Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034), George Town, Pulau Pinang, Malaysia
Beacon Hospital Sdn Bhd ( Site 0033), Petaling Jaya, Selangor, Malaysia
Clinica Vallesur - AUNA ( Site 0360), Arequipa, Ariqipa, Peru
Centro de investigacion Clínica Trujillo ( Site 0358), Trujillo, La Libertad, Peru
Detecta Clínica ( Site 0364), Surquillo, Lima, Peru
Clínica Internacional - Sede San Borja ( Site 0356), Lima, , Peru
Hospital Cayetano Heredia ( Site 0361), Lima, , Peru
Metro Davao Medical and Research Center ( Site 0047), Davao City, Davao Del Sur, Philippines
ST. LUKE'S MEDICAL CENTER ( Site 0046), Quezon City, National Capital Region, Philippines
Cebu Doctors University Hospital ( Site 0045), Cebu, , Philippines
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208), Bydgoszcz, Kujawsko-pomorskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warszawa, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203), Przemysl, Podkarpackie, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202), Prabuty, Pomorskie, Poland
Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207), Racibórz, Slaskie, Poland
Med-Polonia Sp. z o. o. ( Site 0204), Poznan, Wielkopolskie, Poland
Gral Medical SRL-Medical Oncology ( Site 0220), București, Bucuresti, Romania
Cardiomed SRL Cluj-Napoca ( Site 0217), Cluj-Napoca, Cluj, Romania
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216), Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 0215), Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 0219), Timișoara, Timis, Romania
Institutul Oncologic-Oncologie Medicala ( Site 0218), Cluj, , Romania
Chung Shan Medical University Hospital ( Site 0078), Taichung City, Taichung, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 0079), Taipei City, Taipei, Taiwan
E-Da hospital ( Site 0075), Kaohsiung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076), Tainan, , Taiwan
National Taiwan University Hospital-Internal Medicine ( Site 0080), Taipei, , Taiwan
Maharaj Nakorn Chiang Mai Hospital ( Site 0092), Muang, Chiang Mai, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097), Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital ( Site 0090), Bangkok, Krung Thep Maha Nakhon, Thailand
Songklanagarind hospital ( Site 0091), Hatyai, Songkhla, Thailand
Lampang Cancer Hospital ( Site 0098), Lampang, , Thailand
Sunpasitthiprasong Hospital ( Site 0093), Ubon Ratchathani, , Thailand
I.E.U. Medical Point Hastanesi-Oncology ( Site 0266), Izmir, Karsiyaka, Izmir, Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265), Ankara, , Turkey
Liv Hospital Ankara-Oncology ( Site 0274), Ankara, , Turkey
Ankara City Hospital-Medical Oncology ( Site 0268), Ankara, , Turkey
Trakya University-Medical Oncology ( Site 0270), Edirne, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267), Istanbul, , Turkey
VM Medical Park Pendik Hospital ( Site 0271), Istanbul, , Turkey
Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275), Mersin, , Turkey
University College London Hospital ( Site 0305), London, England, United Kingdom
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300), Leicester, Leicestershire, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302), London, London, City Of, United Kingdom
The Clatterbridge Cancer Centre ( Site 0303), Wirral, , United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR