AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT05609968

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)

A Phase 3 study testing Sacituzumab Govitecan and Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 180 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Sacituzumab Govitecan and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
180 sitesin 25 countries
Study dates
6 Feb 2023to 23 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
  • Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
  • Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy
  • Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids
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  • Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
  • Has cardiac disease
  • Myocardial infarction or unstable angina pectoris within 6 months of enrollment
  • History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation
  • New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%
  • Has active chronic inflammatory bowel disease
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
  • Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • Has history of human immunodeficiency virus (HIV) infection
  • History of hepatitis B or known active hepatitis C virus infection
  • Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Have not adequately recovered from major surgery or have ongoing surgical complications

Trial locations and contacts

180 sites in 25 countries.

180 sites in 25 countries

China35 sites

  • Beijing Cancer hospital ( Site 0104)

    Beijing, Beijing Municipality, 100142

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

    Beijing, Beijing Municipality, 100730

  • Beijing Chest Hospital,Capital Medical University ( Site 0105)

    Beijing, Beijing Municipality, 101149

  • The First Hospital of Jilin University ( Site 0117)

    Changchun, Jilin, 130021

  • Jilin Province Tumor Hospital-clinical research ( Site 0118)

    Changchun, Jilin, 130103

  • Xiangya Hospital Central South University ( Site 0124)

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University ( Site 0135)

    Changsha, Hunan, 410011

  • West China Hospital of Sichuan University ( Site 0129)

    Chengdu, Sichuan, 610041

  • Sichuan Cancer hospital. ( Site 0128)

    Chengdu, Sichuan, 610213

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Provincial Cancer Hospital ( Site 0131)

    Fuzhou, Fujian, 350014

  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0125)

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University ( Site 0109)

    Hangzhou, Zhejiang, 310006

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

    Hangzhou, Zhejiang, 310009

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

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital ( Site 0108)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 0119)

    Harbin, Heilongjiang, 150081

  • Second Affiliated hospital of Anhui Medical University ( Site 0126)

    Hefei, Anhui, 230000

  • Anhui Provincial Hospital ( Site 0136)

    Hefei, Anhui, 230071

  • Jinan Central Hospital-oncology department ( Site 0121)

    Jinan, Shandong, 250013

  • LinYi Cancer Hospital ( Site 0120)

    Linyi, Shandong, 276034

  • The Second Affiliated Hospital of Nanchang University ( Site 0134)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112)

    Nanjing, Jiangsu, 210008

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 0113)

    Nanning, Guangxi, 530021

  • Nantong Tumor Hospital-Medical Oncology ( Site 0122)

    Nantong, Jiangsu, 226361

  • Shanghai Chest Hospital ( Site 0101)

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center-Oncology ( Site 0102)

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital, Fudan University ( Site 0103)

    Shanghai, Shanghai Municipality, 200040

  • The First Affliated Hospital of Suzhou University ( Site 0114)

    Suzhou, Jiangsu, 215000

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)

    Wuhan, Hubei, 430000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital ( Site 0107)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)

    Xi'an, Shaanxi, 710061

  • The First Affiliated hospital of Xiamen University ( Site 0132)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 0127)

    Zhengzhou, Henan, 450008

Other trials in China

Japan20 sites

  • Tokyo Metropolitan Komagome Hospital ( Site 0020)

    Bunkyo Ku, Tokyo, 113-8677

  • National Hospital Organization Kyushu Medical Center ( Site 0009)

    Fukuoka, 810-8563

  • Kyushu University Hospital ( Site 0010)

    Fukuoka, 812-8582

  • Kansai Medical University Hospital ( Site 0005)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 0019)

    Kanazawa, Ishikawa-ken, 920-8641

  • Saitama Prefectural Cancer Center ( Site 0002)

    Kitaadachi-gun, Saitama, 362-0806

  • Kurashiki Central Hospital ( Site 0011)

    Kurashiki, Okayama-ken, 710-8602

  • Kurume University Hospital ( Site 0014)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 0008)

    Matsuyama, Ehime, 791-0280

  • Shizuoka Cancer Center ( Site 0004)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777

  • Aichi Cancer Center ( Site 0018)

    Nagoya, Aichi-ken, 464-8681

  • Miyagi Cancer Center ( Site 0001)

    Natori-shi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital ( Site 0017)

    Niigata, Niigata, 951-8566

  • Okayama University Hospital ( Site 0007)

    Okayama, 700-8558

  • Kindai University Hospital ( Site 0013)

    Sakai, Osaka, 590-0197

  • Sendai Kousei Hospital ( Site 0012)

    Sendai, Miyagi, 981-0914

  • Takarazuka City Hospital ( Site 0015)

    Takarazuka, Hyōgo, 665-0827

  • Nippon Medical School Hospital ( Site 0003)

    Tokyo, 113-8603

  • Wakayama Medical University Hospital ( Site 0006)

    Wakayama, 641-8510

  • Kanagawa Cancer Center ( Site 0016)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States16 sites

  • Our Lady of the Lake RMC ( Site 0424)

    Baton Rouge, Louisiana, 70808

  • Clermont Oncology Center ( Site 0421)

    Clermont, Florida, 34711

  • Henry Ford Hospital ( Site 0412)

    Detroit, Michigan, 48202

  • Profound Research LLC ( Site 0440)

    Farmington Hills, Michigan, 48334

  • Houston Methodist Hospital ( Site 0419)

    Houston, Texas, 77030

  • Basil Clinical ( Site 0441)

    Inwood, New York, 11096

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)

    Marietta, Georgia, 30060

  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)

    Miami, Florida, 33136

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

    Minneapolis, Minnesota, 55407

  • Infirmary Cancer Care ( Site 0418)

    Mobile, Alabama, 36607

  • Profound Research LLC ( Site 0444)

    Oceanside, California, 92056-4522

  • Mid Florida Hematology and Oncology Center ( Site 0416)

    Orange City, Florida, 32763

  • Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)

    Portland, Oregon, 97227

  • Oregon Health & Science University ( Site 0427)

    Portland, Oregon, 97239

  • Central Texas Veterans health care ( Site 0414)

    Temple, Texas, 76504

  • White Plains Hospital-Center for Cancer Care ( Site 0403)

    White Plains, New York, 10601

Other trials in United States

Peru8 sites

  • Clinica Vallesur - AUNA ( Site 0360)

    Arequipa, Ariqipa, 15036

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

    Concepción, Departamento de Junín, 12125

  • Clínica Internacional - Sede San Borja ( Site 0356)

    Lima, 15036

  • Instituto Neuro Cardiovascular de las Americas ( Site 0365)

    Lima, 15047

  • Hospital Cayetano Heredia ( Site 0361)

    Lima, 15102

  • Detecta Clínica ( Site 0364)

    Surquillo, Lima region, 15038

  • Centro de investigacion Clínica Trujillo ( Site 0358)

    Trujillo, La Libertad, 13001

  • Clínica San Antonio ( Site 0366)

    Trujillo, La Libertad, 13008

Other trials in Peru

Turkey (Türkiye)8 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)

    Ankara, 06230

  • Liv Hospital Ankara-Oncology ( Site 0274)

    Ankara, 06680

  • Ankara City Hospital-Medical Oncology ( Site 0268)

    Ankara, 06800

  • Trakya University-Medical Oncology ( Site 0270)

    Edirne, 22030

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

    Istanbul, 34722

  • VM Medical Park Pendik Hospital ( Site 0271)

    Istanbul, 34899

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

    Izmir, 35575

  • Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)

    Mersin, 33240

Other trials in Turkey (Türkiye)

Germany7 sites

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

    Berlin, 13585

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)

    Berlin, 14165

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

    Halle, Saxony-Anhalt, 06120

  • Klinikum Kempten ( Site 0655)

    Kempten (Allgäu), Bavaria, 87439

  • Katholisches Klinikum Koblenz ( Site 0650)

    Koblenz, Rhineland-Palatinate, 56073

  • Universitätsmedizin Mannheim ( Site 0654)

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum Würzburg Mitte ( Site 0651)

    Würzburg, Bavaria, 97074

Other trials in Germany

Italy7 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)

    Bergamo, Lombardy, 24127

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)

    Florence, Tuscany, 50134

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)

    Milan, Lombardy, 20133

  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)

    Naples, Napoli, 80131

  • Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)

    Parma, 43126

  • Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)

    Peschiera del Garda, Verona, 37019

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

    Rome, Lazio, 00184

Other trials in Italy

Poland7 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Poznan, Greater Poland Voivodeship, 60-693

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

    Prabuty, Pomeranian Voivodeship, 82-550

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

    Przemyśl, Podkarpackie Voivodeship, 37-700

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

    Racibórz, Silesian Voivodeship, 47-400

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

    Siedlce, Masovian Voivodeship, 08-110

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Taiwan7 sites

  • E-Da hospital ( Site 0075)

    Kaohsiung City, 82445

  • Chung Shan Medical University Hospital ( Site 0078)

    Taichung, Taichung, 402

  • China Medical University Hospital-Internal Medicine ( Site 0083)

    Taichung, 40447

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

    Tainan, 704

  • National Taiwan University Hospital-Internal Medicine ( Site 0080)

    Taipei, 10002

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

    Taipei City, Taipei, 106

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0082)

    Taoyuan, 33305

Other trials in Taiwan

Brazil6 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)

    Barretos, São Paulo, 14784400

  • Hospital Tacchini ( Site 0322)

    Bento Gonçalves, Rio Grande do Sul, 95700-068

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)

    Fortaleza, Ceará, 60336-232

  • Hospital da Cidade de Passo Fundo ( Site 0321)

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Instituto de Oncologia Saint Gallen ( Site 0317)

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

  • A. C. Camargo Cancer Center ( Site 0324)

    São Paulo, 01509-010

Other trials in Brazil

Mexico6 sites

  • Centro de Investigacion Medica Aguascalientes ( Site 0340)

    Aguascalientes, 20116

  • Medical Care and Research SA de CV ( Site 0353)

    Mérida, Yucatán, 97070

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

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization ( Site 0346)

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca ( Site 0351)

    Oaxaca City, 68020

  • COI Tijuana - Centro Oncológico Internacional ( Site 0350)

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

Romania6 sites

  • Gral Medical SRL-Medical Oncology ( Site 0220)

    Bucharest, Bucharest, 031422

  • Cardiomed SRL Cluj-Napoca ( Site 0217)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic-Oncologie Medicala ( Site 0218)

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)

    Craiova, Dolj, 200542

  • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)

    Florești, Cluj, 407280

  • Cabinet Medical Oncomed ( Site 0219)

    Timișoara, Timiș County, 300239

Other trials in Romania

Thailand6 sites

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

    Bangkok, Bangkok, 10300

  • Faculty of Medicine Siriraj Hospital ( Site 0090)

    Bangkok, Bangkok, 10700

  • Songklanagarind hospital ( Site 0091)

    Hat Yai, Changwat Songkhla, 90110

  • Lampang Cancer Hospital ( Site 0098)

    Lampang, Changwat Lampang, 52000

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0092)

    Muang, Chiang Mai, 50200

  • Sunpasitthiprasong Hospital ( Site 0093)

    Ubon Ratchathani, 34000

Other trials in Thailand

Canada5 sites

  • BC Cancer Abbotsford-Medical Oncology ( Site 0433)

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)

    Greenfield Park, Quebec, J4V 2H1

  • St. Marys Hospital Center-Oncology ( Site 0434)

    Montreal, Quebec, H3T 1M5

  • Southlake Health- Oncology Clinical Trials ( Site 0435)

    Newmarket, Ontario, L3Y 2P9

  • Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Israel5 sites

  • Shaare Zedek Medical Center-Oncology ( Site 0176)

    Jerusalem, 9103102

  • Meir Medical Center-oncology ( Site 0171)

    KfarSaba, 4428164

  • Rabin Medical Center-Oncology ( Site 0174)

    Petah Tikva, 4941492

  • Sourasky Medical Center-Oncology ( Site 0175)

    Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center. ( Site 0179)

    Tsrifin, 7033001

Other trials in Israel

South Korea5 sites

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

    Daejeon, Taejon-Kwangyokshi, 35015

  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)

    Hwasun, Jeonranamdo, 58128

  • Pusan National University Yangsan Hospital ( Site 0060)

    Pusan, Kyongsangnam-do, 50612

  • Asan Medical Center ( Site 0064)

    Seoul, 05505

  • Korea University Guro Hospital-Internal Medicine ( Site 0062)

    Seoul

Other trials in South Korea

Latvia4 sites

  • Daugavpils Regional Hospital-Oncology Department ( Site 0194)

    Daugavpils, Daugavpils Novads, 5417

  • Liepjas reionl slimnca ( Site 0191)

    Liepāja, LV-3414

  • Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)

    Riga, 1002

  • RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 0193)

    Riga, LV1079

Other trials in Latvia

United Kingdom4 sites

  • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)

    Leicester, Leicestershire, LE1 5WW

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)

    London, London, City of, EC1A 7BE

  • University College London Hospital ( Site 0305)

    London, London, City of, NW1 2PG

  • The Clatterbridge Cancer Centre ( Site 0303)

    Metropolitan Borough of Wirral, CH63 4JY

Other trials in United Kingdom

Australia3 sites

  • Cancer Research SA-St Andrews Hospital ( Site 0603)

    Adelaide, South Australia, 5000

  • Frankston Hospital-Oncology and Haematology ( Site 0601)

    Frankston, Victoria, 3199

  • Orange Hospital-Clinical Trials Unit ( Site 0600)

    Orange, New South Wales, 2800

Other trials in Australia

Greece3 sites

  • Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)

    Athens, Attica, 115 26

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

    Athens, Attica, 115 27

  • European Interbalkan Medical Center-Oncology Department ( Site 0142)

    Thessaloniki, 570 01

Other trials in Greece

Malaysia3 sites

  • Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)

    George Town, Pulau Pinang, 10450

  • Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)

    Kota Bharu, Kelantan, 15586

  • Beacon Hospital Sdn Bhd ( Site 0033)

    Petaling Jaya, Selangor, 46050

Other trials in Malaysia

Philippines3 sites

  • Cebu Doctors University Hospital ( Site 0045)

    Cebu, 6000

  • Metro Davao Medical and Research Center ( Site 0047)

    Davao City, Davao Del Sur, 8000

  • ST. LUKE'S MEDICAL CENTER ( Site 0046)

    Quezon City, National Capital Region, 1102

Other trials in Philippines

Chile2 sites

  • Oncovida ( Site 0334)

    Santiago, Region M. de Santiago, 7500994

  • Pontificia Universidad Catolica de Chile ( Site 0332)

    Santiago, Region M. de Santiago, 8330024

Other trials in Chile

Estonia2 sites

  • North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)

    Tallinn, Harju, 13419

  • Tartu University Hospital-Radiotherapy and oncology ( Site 0620)

    Tartu, Tartu, 50406

Other trials in Estonia

Lithuania2 sites

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

    Kaunas, Kaunas County, 50161

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

    Vilnius, LT-08406

Other trials in Lithuania

About this study

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)

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%).

Being tested
Sacituzumab Govitecan, Pembrolizumab
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death-2 (PD2, PD-2), Programmed Death-Ligand 2 (PDL2, PD-L2), Trophoblast Cell Surface Antigen-2 (TROP-2), Antibody-Drug Conjugate (ADC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanBiological

    Also called Trodelvy®

    IV infusion

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    IV infusion

Study groups in NCT05609968
Study groupRoleWhat they receive
Pembrolizumab + Sacituzumab GovitecanExperimentalParticipants 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).
Receives: Biological: Sacituzumab Govitecan; Biological: Pembrolizumab
PembrolizumabExperimentalParticipants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).
Receives: Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as per the Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 is modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 38 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 48 months

Secondary outcomes (16)

  1. Objective Response (OR)

    OR is defined as the confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by BICR.

    Measured: Up to approximately 38 months

  2. Duration of Response (DOR)

    DOR is defined as the time from the first documented evidence of a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to approximately 48 months

  3. Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

    Measured: Baseline and up to approximately 48 months

  4. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.

    Measured: Baseline and up to approximately 48 months

  5. Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.

    Measured: Baseline and up to approximately 48 months

  6. Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.

    Measured: Baseline and up to approximately 48 months

  7. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate more frequent coughing and a worse outcome. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented.

    Measured: Baseline and up to approximately 48 months

  8. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate worse level of chest pain. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.

    Measured: Baseline and up to approximately 48 months

  9. Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") will be scored on a 7-point scale (1=Very Poor to 7=Excellent). Higher scores indicate a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.

    Measured: Up to approximately 48 months

  10. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented.

    Measured: Up to approximately 48 months

  11. TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented.

    Measured: Up to approximately 48 months

  12. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 11

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Item 8 will be presented.

    Measured: Up to approximately 48 months

  13. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate more frequent coughing and a worse outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 31 will be presented.

    Measured: Up to approximately 48 months

  14. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 40 will be presented.

    Measured: Up to approximately 48 months

  15. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who experience an AE will be reported.

    Measured: Up to approximately 48 months

  16. Number of Participants Who Discontinue Study Treatment Due To an AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start6 Feb 2023
  3. Primary completion12 Jan 2027 (estimated)
  4. Study completion23 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
614 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609968
Sponsor's protocol ID
3475-D46
Other IDs
MK-3475-D46, PHRR230203-005387, jRCT2031230031, 2023-503501-11-00, U1111-1287-4239, 2022-000836-49, 2023
Status last verified
Dec 2025
First submitted
2 Nov 2022
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan and Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 180 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in China, Japan, United States, Peru, Turkey (Türkiye) and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 38 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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