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)
Status: Active_not_recruiting
Location: See all (180) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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%).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
• Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
• Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
• Has a life expectancy of at least 3 months
Locations
United States
Alabama
Infirmary Cancer Care ( Site 0418)
Mobile
California
Profound Research LLC ( Site 0444)
Oceanside
Florida
Clermont Oncology Center ( Site 0421)
Clermont
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)
Miami
Mid Florida Hematology and Oncology Center ( Site 0416)
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)
Marietta
Louisiana
Our Lady of the Lake RMC ( Site 0424)
Baton Rouge
Michigan
Henry Ford Hospital ( Site 0412)
Detroit
Profound Research LLC ( Site 0440)
Farmington Hills
Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)
Minneapolis
New York
Basil Clinical ( Site 0441)
Inwood
White Plains Hospital-Center for Cancer Care ( Site 0403)
White Plains
Oregon
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)
Portland
Oregon Health & Science University ( Site 0427)
Portland
Texas
Houston Methodist Hospital ( Site 0419)
Houston
Central Texas Veterans health care ( Site 0414)
Temple
Other Locations
Australia
Cancer Research SA-St Andrews Hospital ( Site 0603)
Adelaide
Frankston Hospital-Oncology and Haematology ( Site 0601)
Frankston
Orange Hospital-Clinical Trials Unit ( Site 0600)
Orange
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)
Barretos
Hospital Tacchini ( Site 0322)
Bento Gonçalves
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)
Fortaleza
Hospital da Cidade de Passo Fundo ( Site 0321)
Passo Fundo
Instituto de Oncologia Saint Gallen ( Site 0317)
Santa Cruz Do Sul
A. C. Camargo Cancer Center ( Site 0324)
São Paulo
Canada
BC Cancer Abbotsford-Medical Oncology ( Site 0433)
Abbotsford
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)
Greenfield Park
St. Marys Hospital Center-Oncology ( Site 0434)
Montreal
Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)
Newmarket
Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)
Trois-rivières
Chile
Oncovida ( Site 0334)
Santiago
Pontificia Universidad Catolica de Chile ( Site 0332)
Santiago
China
Beijing Cancer hospital ( Site 0104)
Beijing
Beijing Chest Hospital,Capital Medical University ( Site 0105)
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)
Beijing
Jilin Province Tumor Hospital-clinical research ( Site 0118)
Changchun
The First Hospital of Jilin University ( Site 0117)
Changchun
The Second Xiangya Hospital of Central South University ( Site 0135)
Changsha
Xiangya Hospital Central South University ( Site 0124)
Changsha
Sichuan Cancer hospital. ( Site 0128)
Chengdu
West China Hospital of Sichuan University ( Site 0129)
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)
Chongqing
Fujian Provincial Cancer Hospital ( Site 0131)
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0125)
Guangzhou
Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)
Hangzhou
The First Affiliated Hospital, Zhejiang University ( Site 0109)
Hangzhou
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)
Hangzhou
Zhejiang Cancer Hospital ( Site 0108)
Hangzhou
Harbin Medical University Cancer Hospital ( Site 0119)
Harbin
Anhui Provincial Hospital ( Site 0136)
Hefei
Second Affiliated hospital of Anhui Medical University ( Site 0126)
Hefei
Jinan Central Hospital-oncology department ( Site 0121)
Jinan
LinYi Cancer Hospital ( Site 0120)
Linyi
The Second Affiliated Hospital of Nanchang University ( Site 0134)
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112)
Nanjing
Affiliated Cancer Hospital of Guangxi Medical University ( Site 0113)
Nanning
Nantong Tumor Hospital-Medical Oncology ( Site 0122)
Nantong
Fudan University Shanghai Cancer Center-Oncology ( Site 0102)
Shanghai
Huashan Hospital, Fudan University ( Site 0103)
Shanghai
Shanghai Chest Hospital ( Site 0101)
Shanghai
The First Affliated Hospital of Suzhou University ( Site 0114)
Suzhou
Hubei Cancer Hospital ( Site 0107)
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)
Xi'an
The First Affiliated hospital of Xiamen University ( Site 0132)
Xiamen
Henan Cancer Hospital ( Site 0127)
Zhengzhou
Estonia
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)
Tallinn
Tartu University Hospital-Radiotherapy and oncology ( Site 0620)
Tartu
Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)
Berlin
Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 0656)
Berlin
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)
Halle
Klinikum Kempten ( Site 0655)
Kempten (allgäu)
Katholisches Klinikum Koblenz ( Site 0650)
Koblenz
Universitätsmedizin Mannheim ( Site 0654)
Mannheim
Klinikum Würzburg Mitte ( Site 0651)
Würzburg
Greece
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)
Athens
Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 0140)
Athens
European Interbalkan Medical Center-Oncology Department ( Site 0142)
Thessaloniki
Israel
Shaare Zedek Medical Center-Oncology ( Site 0176)
Jerusalem
Meir Medical Center-oncology ( Site 0171)
Kfarsaba
Rabin Medical Center-Oncology ( Site 0174)
Petah Tikva
Sourasky Medical Center-Oncology ( Site 0175)
Tel Aviv
Yitzhak Shamir Medical Center. ( Site 0179)
Ẕerifin
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)
Bergamo
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)
Milan
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)
Naples
Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)
Parma
Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)
Peschiera Del Garda
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)
Rome
Japan
Tokyo Metropolitan Komagome Hospital ( Site 0020)
Bunkyo Ku
Kyushu University Hospital ( Site 0010)
Fukuoka
National Hospital Organization Kyushu Medical Center ( Site 0009)
Fukuoka
Kansai Medical University Hospital ( Site 0005)
Hirakata
Kanazawa University Hospital ( Site 0019)
Kanazawa
Saitama Prefectural Cancer Center ( Site 0002)
Kitaadachi-gun
Kurashiki Central Hospital ( Site 0011)
Kurashiki
Kurume University Hospital ( Site 0014)
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 0008)
Matsuyama
Shizuoka Cancer Center ( Site 0004)
Nagaizumi-cho,sunto-gun
Aichi Cancer Center ( Site 0018)
Nagoya
Miyagi Cancer Center ( Site 0001)
Natori-shi
Niigata Cancer Center Hospital ( Site 0017)
Niigata
Okayama University Hospital ( Site 0007)
Okayama
Kindai University Hospital ( Site 0013)
Sakai
Sendai Kousei Hospital ( Site 0012)
Sendai
Takarazuka City Hospital ( Site 0015)
Takarazuka
Nippon Medical School Hospital ( Site 0003)
Tokyo
Wakayama Medical University Hospital ( Site 0006)
Wakayama
Kanagawa Cancer Center ( Site 0016)
Yokohama
Latvia
Daugavpils Regional Hospital-Oncology Department ( Site 0194)
Daugavpils
Liepjas reionl slimnca ( Site 0191)
Liepāja
Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)
Riga
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 0193)
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)
Kaunas
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0691)
Vilnius
Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)
George Town
Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)
Kota Bharu
Beacon Hospital Sdn Bhd ( Site 0033)
Petaling Jaya
Mexico
Centro de Investigacion Medica Aguascalientes ( Site 0340)
Aguascalientes
Medical Care and Research SA de CV ( Site 0353)
Mérida
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0352)
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0351)
Oaxaca City
Oaxaca Site Management Organization ( Site 0346)
Oaxaca City
COI Tijuana - Centro Oncológico Internacional ( Site 0350)
Tijuana
Peru
Clinica Vallesur - AUNA ( Site 0360)
Arequipa
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)
Concepción
Clínica Internacional - Sede San Borja ( Site 0356)
Lima
Hospital Cayetano Heredia ( Site 0361)
Lima
Instituto Neuro Cardiovascular de las Americas ( Site 0365)
Lima
Detecta Clínica ( Site 0364)
Surquillo
Centro de investigacion Clínica Trujillo ( Site 0358)
Trujillo
Clínica San Antonio ( Site 0366)
Trujillo
Philippines
Cebu Doctors University Hospital ( Site 0045)
Cebu
Metro Davao Medical and Research Center ( Site 0047)
Davao City
ST. LUKE'S MEDICAL CENTER ( Site 0046)
Quezon City
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)
Bydgoszcz
Med-Polonia Sp. z o. o. ( Site 0204)
Poznan
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)
Prabuty
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)
Przemyśl
Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)
Racibórz
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)
Siedlce
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0200)
Warsaw
Republic of Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 0063)
Daejeon
Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)
Hwasun
Pusan National University Yangsan Hospital ( Site 0060)
Pusan
Asan Medical Center ( Site 0064)
Seoul
Korea University Guro Hospital-Internal Medicine ( Site 0062)
Seoul
Romania
Gral Medical SRL-Medical Oncology ( Site 0220)
Bucharest
Cardiomed SRL Cluj-Napoca ( Site 0217)
Cluj-napoca
Institutul Oncologic-Oncologie Medicala ( Site 0218)
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)
Craiova
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)
Florești
Cabinet Medical Oncomed ( Site 0219)
Timișoara
Taiwan
E-Da hospital ( Site 0075)
Kaohsiung City
China Medical University Hospital-Internal Medicine ( Site 0083)
Taichung
Chung Shan Medical University Hospital ( Site 0078)
Taichung
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)
Tainan
National Taiwan University Hospital-Internal Medicine ( Site 0080)
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 0079)
Taipei City
Chang Gung Medical Foundation-Linkou Branch ( Site 0082)
Taoyuan District
Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 0090)
Bangkok
Songklanagarind hospital ( Site 0091)
Hat Yai
Lampang Cancer Hospital ( Site 0098)
Lampang
Maharaj Nakorn Chiang Mai Hospital ( Site 0092)
Muang
Sunpasitthiprasong Hospital ( Site 0093)
Ubon Ratchathani
Turkey
Ankara City Hospital-Medical Oncology ( Site 0268)
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)
Ankara
Liv Hospital Ankara-Oncology ( Site 0274)
Ankara
Trakya University-Medical Oncology ( Site 0270)
Edirne
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 0267)
Istanbul
VM Medical Park Pendik Hospital ( Site 0271)
Istanbul
I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)
Izmir
Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)
Mersin
United Kingdom
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)
Leicester
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)
London
University College London Hospital ( Site 0305)
London
The Clatterbridge Cancer Centre ( Site 0303)
Metropolitan Borough Of Wirral
Time Frame
Start Date: 2023-02-06
Completion Date: 2028-08-23
Participants
Target number of participants: 614
Treatments
Experimental: Pembrolizumab + Sacituzumab Govitecan
Participants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days).
Experimental: Pembrolizumab
Participants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: Gilead Sciences