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ACTIVE NOT RECRUITING
NCT05609968
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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%).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

614

Start Date

2023-02-06

Completion Date

2028-08-23

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sacituzumab Govitecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

Locations (180)

Infirmary Cancer Care ( Site 0418)

Mobile, Alabama, United States

Profound Research LLC ( Site 0444)

Oceanside, California, 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

Profound Research LLC ( Site 0440)

Farmington Hills, Michigan, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)

Minneapolis, Minnesota, United States

Basil Clinical ( Site 0441)

Inwood, New York, 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

Oregon Health & Science University ( Site 0427)

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, Ceará, Brazil

Hospital Tacchini ( Site 0322)

Bento Gonçalves, 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, São Paulo, Brazil

A. C. Camargo Cancer Center ( Site 0324)

São Paulo, Brazil

BC Cancer Abbotsford-Medical Oncology ( Site 0433)

Abbotsford British Columbia, British Columbia, Canada

Southlake Health- 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 ( 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 Municipality, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)

Beijing, Beijing Municipality, China

Beijing Chest Hospital,Capital Medical University ( Site 0105)

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)

Chongqing, Chongqing Municipality, 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 ( Site 0125)

Guangzhou, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University ( 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-clinical research ( 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 Municipality, China

Fudan University Shanghai Cancer Center-Oncology ( Site 0102)

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University ( Site 0103)

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University ( Site 0129)

Chengdu, Sichuan, China

Sichuan Cancer hospital. ( Site 0128)

Chengdu, Sichuan, China

The First Affiliated Hospital, Zhejiang University ( Site 0109)

Hangzhou, Zhejiang, China

The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0108)

Hangzhou, Zhejiang, China

North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)

Tallinn, Harju, Estonia

Tartu University Hospital-Radiotherapy and oncology ( Site 0620)

Tartu, Tartu, Estonia

Universitätsmedizin Mannheim ( Site 0654)

Mannheim, Baden-Wurttemberg, Germany

Klinikum Kempten ( Site 0655)

Kempten (Allgäu), Bavaria, Germany

Klinikum Würzburg Mitte ( Site 0651)

Würzburg, Bavaria, Germany

Katholisches Klinikum Koblenz ( Site 0650)

Koblenz, Rhineland-Palatinate, Germany

Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)

Halle, Saxony-Anhalt, Germany

Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 0656)

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, Attica, Greece

Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 0140)

Athens, Attica, 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)

Ẕerifin, Israel

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)

Rome, Lazio, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)

Bergamo, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)

Milan, Lombardy, 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)

Florence, Tuscany, 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 ( Site 0018)

Nagoya, Aichi-ken, 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, Hyōgo, Japan

Kanazawa University Hospital ( Site 0019)

Kanazawa, Ishikawa-ken, Japan

Kanagawa Cancer Center ( Site 0016)

Yokohama, Kanagawa, Japan

Miyagi Cancer Center ( Site 0001)

Natori-shi, Miyagi, Japan

Sendai Kousei Hospital ( Site 0012)

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital ( Site 0017)

Niigata, Niigata, Japan

Kurashiki Central Hospital ( Site 0011)

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital ( Site 0005)

Hirakata, Osaka, Japan

Kindai University Hospital ( Site 0013)

Sakai, Osaka, Japan

Saitama Prefectural Cancer Center ( Site 0002)

Kitaadachi-gun, Saitama, Japan

Shizuoka Cancer Center ( Site 0004)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Tokyo Metropolitan Komagome Hospital ( Site 0020)

Bunkyo Ku, Tokyo, 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

Daugavpils Regional Hospital-Oncology Department ( Site 0194)

Daugavpils, Daugavpils Novads, Latvia

Liepjas reionl slimnca ( Site 0191)

Liepāja, 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 ( Site 0193)

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)

Kaunas, Kaunas County, Lithuania

Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0691)

Vilnius, 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

COI Tijuana - Centro Oncológico Internacional ( Site 0350)

Tijuana, Estado de Baja California, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0352)

Monterrey, Nuevo León, Mexico

Medical Care and Research SA de CV ( Site 0353)

Mérida, Yucatán, Mexico

Centro de Investigacion Medica Aguascalientes ( Site 0340)

Aguascalientes, Mexico

Oaxaca Site Management Organization ( Site 0346)

Oaxaca City, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0351)

Oaxaca City, Mexico

Clinica Vallesur - AUNA ( Site 0360)

Arequipa, Ariqipa, Peru

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)

Concepción, Departamento de Junín, Peru

Centro de investigacion Clínica Trujillo ( Site 0358)

Trujillo, La Libertad, Peru

Clínica San Antonio ( Site 0366)

Trujillo, La Libertad, Peru

Detecta Clínica ( Site 0364)

Surquillo, Lima region, Peru

Clínica Internacional - Sede San Borja ( Site 0356)

Lima, Peru

Instituto Neuro Cardiovascular de las Americas ( Site 0365)

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

Med-Polonia Sp. z o. o. ( Site 0204)

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)

Siedlce, Masovian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0200)

Warsaw, Masovian Voivodeship, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)

Przemyśl, Podkarpackie Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)

Prabuty, Pomeranian Voivodeship, Poland

Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)

Racibórz, Silesian Voivodeship, Poland

Gral Medical SRL-Medical Oncology ( Site 0220)

Bucharest, București, Romania

Cardiomed SRL Cluj-Napoca ( Site 0217)

Cluj-Napoca, Cluj, Romania

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)

Florești, Cluj, Romania

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)

Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 0219)

Timișoara, Timiș County, Romania

Institutul Oncologic-Oncologie Medicala ( Site 0218)

Cluj-Napoca, Romania

Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)

Hwasun, Jeonranamdo, South Korea

Pusan National University Yangsan Hospital ( Site 0060)

Pusan, Kyongsangnam-do, South Korea

Chungnam national university hospital-Department of Internal Medicine ( Site 0063)

Daejeon, Taejon-Kwangyokshi, South Korea

Asan Medical Center ( Site 0064)

Seoul, South Korea

Korea University Guro Hospital-Internal Medicine ( Site 0062)

Seoul, South Korea

Chung Shan Medical University Hospital ( Site 0078)

Taichung, Taichung, Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 0079)

Taipei City, Taipei, Taiwan

E-Da hospital ( Site 0075)

Kaohsiung City, Taiwan

China Medical University Hospital-Internal Medicine ( Site 0083)

Taichung, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)

Tainan, Taiwan

National Taiwan University Hospital-Internal Medicine ( Site 0080)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0082)

Taoyuan District, Taiwan

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 0090)

Bangkok, Bangkok, Thailand

Lampang Cancer Hospital ( Site 0098)

Lampang, Changwat Lampang, Thailand

Songklanagarind hospital ( Site 0091)

Hat Yai, Changwat Songkhla, Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 0092)

Muang, Chiang Mai, Thailand

Sunpasitthiprasong Hospital ( Site 0093)

Ubon Ratchathani, Thailand

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)

Ankara, Turkey (Türkiye)

Liv Hospital Ankara-Oncology ( Site 0274)

Ankara, Turkey (Türkiye)

Ankara City Hospital-Medical Oncology ( Site 0268)

Ankara, Turkey (Türkiye)

Trakya University-Medical Oncology ( Site 0270)

Edirne, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 0267)

Istanbul, Turkey (Türkiye)

VM Medical Park Pendik Hospital ( Site 0271)

Istanbul, Turkey (Türkiye)

I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)

Izmir, Turkey (Türkiye)

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)

Mersin, Turkey (Türkiye)

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

University College London Hospital ( Site 0305)

London, London, City of, United Kingdom

The Clatterbridge Cancer Centre ( Site 0303)

Metropolitan Borough of Wirral, United Kingdom