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)

NCT05609968 | Active Not Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: 3475-D46MK-3475-D46PHRR230203-005387jRCT20312300312023-503501-11-00U1111-1287-42392022-000836-49
• Study Type: interventional
• Target: 614
• Locations: 25 countries
• Sites: 180

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%).

Conditions

Carcinoma, Non-Small-Cell Lung

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 38 months

• Overall Survival (OS)

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

  Up to approximately 48 months

Secondary Outcomes (16)

• Objective Response (OR)

  Up to approximately 38 months

• Duration of Response (DOR)

  Up to approximately 48 months

• 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)

  Baseline and up to approximately 48 months

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

  Baseline and up to approximately 48 months

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

  Baseline and up to approximately 48 months

Study Arms (2)

Pembrolizumab + Sacituzumab Govitecan

EXPERIMENTAL

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).

Biological: Sacituzumab Govitecan; Biological: Pembrolizumab

Pembrolizumab

EXPERIMENTAL

Participants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).

Biological: Pembrolizumab

Interventions

Sacituzumab Govitecan BIOLOGICAL

IV infusion

Also known as: Trodelvy®

Pembrolizumab + Sacituzumab Govitecan

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, Keytruda®

Pembrolizumab; Pembrolizumab + Sacituzumab Govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Gilead Sciences: collaborator

Study Sites (180)

Infirmary Cancer Care ( Site 0418)

Mobile, Alabama, 36607, United States

Location

Profound Research LLC ( Site 0444)

Oceanside, California, 92056-4522, United States

Location

Clermont Oncology Center ( Site 0421)

Clermont, Florida, 34711, United States

Location

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

Miami, Florida, 33136, United States

Location

Mid Florida Hematology and Oncology Center ( Site 0416)

Orange City, Florida, 32763, United States

Location

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

Marietta, Georgia, 30060, United States

Location

Our Lady of the Lake RMC ( Site 0424)

Baton Rouge, Louisiana, 70808, United States

Location

Henry Ford Hospital ( Site 0412)

Detroit, Michigan, 48202, United States

Location

Profound Research LLC ( Site 0440)

Farmington Hills, Michigan, 48334, United States

Location

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

Minneapolis, Minnesota, 55407, United States

Location

Basil Clinical ( Site 0441)

Inwood, New York, 11096, United States

Location

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

White Plains, New York, 10601, United States

Location

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

Portland, Oregon, 97227, United States

Location

Oregon Health & Science University ( Site 0427)

Portland, Oregon, 97239, United States

Location

Houston Methodist Hospital ( Site 0419)

Houston, Texas, 77030, United States

Location

Central Texas Veterans health care ( Site 0414)

Temple, Texas, 76504, United States

Location

Orange Hospital-Clinical Trials Unit ( Site 0600)

Orange, New South Wales, 2800, Australia

Location

Cancer Research SA-St Andrews Hospital ( Site 0603)

Adelaide, South Australia, 5000, Australia

Location

Frankston Hospital-Oncology and Haematology ( Site 0601)

Frankston, Victoria, 3199, Australia

Location

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)

Fortaleza, Ceará, 60336-232, Brazil

Location

Hospital Tacchini ( Site 0322)

Bento Gonçalves, Rio Grande do Sul, 95700-068, Brazil

Location

Hospital da Cidade de Passo Fundo ( Site 0321)

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Instituto de Oncologia Saint Gallen ( Site 0317)

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

Location

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

Barretos, São Paulo, 14784400, Brazil

Location

A. C. Camargo Cancer Center ( Site 0324)

São Paulo, 01509-010, Brazil

Location

BC Cancer Abbotsford-Medical Oncology ( Site 0433)

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

Location

Southlake Health- Oncology Clinical Trials ( Site 0435)

Newmarket, Ontario, L3Y 2P9, Canada

Location

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

Greenfield Park, Quebec, J4V 2H1, Canada

Location

St. Marys Hospital Center-Oncology ( Site 0434)

Montreal, Quebec, H3T 1M5, Canada

Location

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

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Oncovida ( Site 0334)

Santiago, Region M. de Santiago, 7500994, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0332)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Second Affiliated hospital of Anhui Medical University ( Site 0126)

Hefei, Anhui, 230000, China

Location

Anhui Provincial Hospital ( Site 0136)

Hefei, Anhui, 230071, China

Location

Beijing Cancer hospital ( Site 0104)

Beijing, Beijing Municipality, 100142, China

Location

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

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chest Hospital,Capital Medical University ( Site 0105)

Beijing, Beijing Municipality, 101149, China

Location

Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Provincial Cancer Hospital ( Site 0131)

Fuzhou, Fujian, 350014, China

Location

The First Affiliated hospital of Xiamen University ( Site 0132)

Xiamen, Fujian, 361003, China

Location

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

Guangzhou, Guangdong, 510515, China

Location

Affiliated Cancer Hospital of Guangxi Medical University ( Site 0113)

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital ( Site 0119)

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital ( Site 0127)

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430000, China

Location

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

Wuhan, Hubei, 430048, China

Location

Hubei Cancer Hospital ( Site 0107)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University ( Site 0124)

Changsha, Hunan, 410008, China

Location

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

Changsha, Hunan, 410011, China

Location

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

Nanjing, Jiangsu, 210008, China

Location

Nantong Tumor Hospital-Medical Oncology ( Site 0122)

Nantong, Jiangsu, 226361, China

Location

The First Affliated Hospital of Suzhou University ( Site 0114)

Suzhou, Jiangsu, 215000, China

Location

The Second Affiliated Hospital of Nanchang University ( Site 0134)

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University ( Site 0117)

Changchun, Jilin, 130021, China

Location

Jilin Province Tumor Hospital-clinical research ( Site 0118)

Changchun, Jilin, 130103, China

Location

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

Xi'an, Shaanxi, 710061, China

Location

Jinan Central Hospital-oncology department ( Site 0121)

Jinan, Shandong, 250013, China

Location

LinYi Cancer Hospital ( Site 0120)

Linyi, Shandong, 276034, China

Location

Shanghai Chest Hospital ( Site 0101)

Shanghai, Shanghai Municipality, 200030, China

Location

Fudan University Shanghai Cancer Center-Oncology ( Site 0102)

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital, Fudan University ( Site 0103)

Shanghai, Shanghai Municipality, 200040, China

Location

West China Hospital of Sichuan University ( Site 0129)

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer hospital. ( Site 0128)

Chengdu, Sichuan, 610213, China

Location

The First Affiliated Hospital, Zhejiang University ( Site 0109)

Hangzhou, Zhejiang, 310006, China

Location

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

Hangzhou, Zhejiang, 310009, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital ( Site 0108)

Hangzhou, Zhejiang, 310022, China

Location

North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)

Tallinn, Harju, 13419, Estonia

Location

Tartu University Hospital-Radiotherapy and oncology ( Site 0620)

Tartu, Tartu, 50406, Estonia

Location

Universitätsmedizin Mannheim ( Site 0654)

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Kempten ( Site 0655)

Kempten (Allgäu), Bavaria, 87439, Germany

Location

Klinikum Würzburg Mitte ( Site 0651)

Würzburg, Bavaria, 97074, Germany

Location

Katholisches Klinikum Koblenz ( Site 0650)

Koblenz, Rhineland-Palatinate, 56073, Germany

Location

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

Halle, Saxony-Anhalt, 06120, Germany

Location

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

Berlin, 13585, Germany

Location

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

Berlin, 14165, Germany

Location

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

Athens, Attica, 115 26, Greece

Location

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

Athens, Attica, 115 27, Greece

Location

European Interbalkan Medical Center-Oncology Department ( Site 0142)

Thessaloniki, 570 01, Greece

Location

Shaare Zedek Medical Center-Oncology ( Site 0176)

Jerusalem, 9103102, Israel

Location

Meir Medical Center-oncology ( Site 0171)

KfarSaba, 4428164, Israel

Location

Rabin Medical Center-Oncology ( Site 0174)

Petah Tikva, 4941492, Israel

Location

Sourasky Medical Center-Oncology ( Site 0175)

Tel Aviv, 6423906, Israel

Location

Yitzhak Shamir Medical Center. ( Site 0179)

Ẕerifin, 7033001, Israel

Location

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

Rome, Lazio, 00184, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)

Bergamo, Lombardy, 24127, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)

Milan, Lombardy, 20133, Italy

Location

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

Naples, Napoli, 80131, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

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

Peschiera del Garda, Verona, 37019, Italy

Location

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

Parma, 43126, Italy

Location

Aichi Cancer Center ( Site 0018)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 0008)

Matsuyama, Ehime, 791-0280, Japan

Location

Kurume University Hospital ( Site 0014)

Kurume, Fukuoka, 830-0011, Japan

Location

Takarazuka City Hospital ( Site 0015)

Takarazuka, Hyōgo, 665-0827, Japan

Location

Kanazawa University Hospital ( Site 0019)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 0016)

Yokohama, Kanagawa, 241-8515, Japan

Location

Miyagi Cancer Center ( Site 0001)

Natori-shi, Miyagi, 981-1293, Japan

Location

Sendai Kousei Hospital ( Site 0012)

Sendai, Miyagi, 981-0914, Japan

Location

Niigata Cancer Center Hospital ( Site 0017)

Niigata, Niigata, 951-8566, Japan

Location

Kurashiki Central Hospital ( Site 0011)

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Kansai Medical University Hospital ( Site 0005)

Hirakata, Osaka, 573-1191, Japan

Location

Kindai University Hospital ( Site 0013)

Sakai, Osaka, 590-0197, Japan

Location

Saitama Prefectural Cancer Center ( Site 0002)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center ( Site 0004)

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

Location

Tokyo Metropolitan Komagome Hospital ( Site 0020)

Bunkyo Ku, Tokyo, 113-8677, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0009)

Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital ( Site 0010)

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital ( Site 0007)

Okayama, 700-8558, Japan

Location

Nippon Medical School Hospital ( Site 0003)

Tokyo, 113-8603, Japan

Location

Wakayama Medical University Hospital ( Site 0006)

Wakayama, 641-8510, Japan

Location

Daugavpils Regional Hospital-Oncology Department ( Site 0194)

Daugavpils, Daugavpils Novads, 5417, Latvia

Location

Liepjas reionl slimnca ( Site 0191)

Liepāja, LV-3414, Latvia

Location

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

Riga, 1002, Latvia

Location

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

Riga, LV1079, Latvia

Location

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

Kaunas, Kaunas County, 50161, Lithuania

Location

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

Vilnius, LT-08406, Lithuania

Location

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

Kota Bharu, Kelantan, 15586, Malaysia

Location

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

George Town, Pulau Pinang, 10450, Malaysia

Location

Beacon Hospital Sdn Bhd ( Site 0033)

Petaling Jaya, Selangor, 46050, Malaysia

Location

COI Tijuana - Centro Oncológico Internacional ( Site 0350)

Tijuana, Estado de Baja California, 22010, Mexico

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

Medical Care and Research SA de CV ( Site 0353)

Mérida, Yucatán, 97070, Mexico

Location

Centro de Investigacion Medica Aguascalientes ( Site 0340)

Aguascalientes, 20116, Mexico

Location

Oaxaca Site Management Organization ( Site 0346)

Oaxaca City, 68000, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 0351)

Oaxaca City, 68020, Mexico

Location

Clinica Vallesur - AUNA ( Site 0360)

Arequipa, Ariqipa, 15036, Peru

Location

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

Concepción, Departamento de Junín, 12125, Peru

Location

Centro de investigacion Clínica Trujillo ( Site 0358)

Trujillo, La Libertad, 13001, Peru

Location

Clínica San Antonio ( Site 0366)

Trujillo, La Libertad, 13008, Peru

Location

Detecta Clínica ( Site 0364)

Surquillo, Lima region, 15038, Peru

Location

Clínica Internacional - Sede San Borja ( Site 0356)

Lima, 15036, Peru

Location

Instituto Neuro Cardiovascular de las Americas ( Site 0365)

Lima, 15047, Peru

Location

Hospital Cayetano Heredia ( Site 0361)

Lima, 15102, Peru

Location

Metro Davao Medical and Research Center ( Site 0047)

Davao City, Davao Del Sur, 8000, Philippines

Location

ST. LUKE'S MEDICAL CENTER ( Site 0046)

Quezon City, National Capital Region, 1102, Philippines

Location

Cebu Doctors University Hospital ( Site 0045)

Cebu, 6000, Philippines

Location

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

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

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

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

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

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

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

Prabuty, Pomeranian Voivodeship, 82-550, Poland

Location

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

Racibórz, Silesian Voivodeship, 47-400, Poland

Location

Gral Medical SRL-Medical Oncology ( Site 0220)

Bucharest, București, 031422, Romania

Location

Cardiomed SRL Cluj-Napoca ( Site 0217)

Cluj-Napoca, Cluj, 400015, Romania

Location

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)

Florești, Cluj, 407280, Romania

Location

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)

Craiova, Dolj, 200542, Romania

Location

Cabinet Medical Oncomed ( Site 0219)

Timișoara, Timiș County, 300239, Romania

Location

Institutul Oncologic-Oncologie Medicala ( Site 0218)

Cluj-Napoca, 400015, Romania

Location

Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)

Hwasun, Jeonranamdo, 58128, South Korea

Location

Pusan National University Yangsan Hospital ( Site 0060)

Pusan, Kyongsangnam-do, 50612, South Korea

Location

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

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

Location

Asan Medical Center ( Site 0064)

Seoul, 05505, South Korea

Location

Korea University Guro Hospital-Internal Medicine ( Site 0062)

Seoul, South Korea

Location

Chung Shan Medical University Hospital ( Site 0078)

Taichung, Taichung, 402, Taiwan

Location

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

Taipei City, Taipei, 106, Taiwan

Location

E-Da hospital ( Site 0075)

Kaohsiung City, 82445, Taiwan

Location

China Medical University Hospital-Internal Medicine ( Site 0083)

Taichung, 40447, Taiwan

Location

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

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Internal Medicine ( Site 0080)

Taipei, 10002, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 0082)

Taoyuan District, 33305, Taiwan

Location

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

Bangkok, Bangkok, 10300, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 0090)

Bangkok, Bangkok, 10700, Thailand

Location

Lampang Cancer Hospital ( Site 0098)

Lampang, Changwat Lampang, 52000, Thailand

Location

Songklanagarind hospital ( Site 0091)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 0092)

Muang, Chiang Mai, 50200, Thailand

Location

Sunpasitthiprasong Hospital ( Site 0093)

Ubon Ratchathani, 34000, Thailand

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)

Ankara, 06230, Turkey (Türkiye)

Location

Liv Hospital Ankara-Oncology ( Site 0274)

Ankara, 06680, Turkey (Türkiye)

Location

Ankara City Hospital-Medical Oncology ( Site 0268)

Ankara, 06800, Turkey (Türkiye)

Location

Trakya University-Medical Oncology ( Site 0270)

Edirne, 22030, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

VM Medical Park Pendik Hospital ( Site 0271)

Istanbul, 34899, Turkey (Türkiye)

Location

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

Izmir, 35575, Turkey (Türkiye)

Location

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)

Mersin, 33240, Turkey (Türkiye)

Location

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

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

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

London, London, City of, EC1A 7BE, United Kingdom

Location

University College London Hospital ( Site 0305)

London, London, City of, NW1 2PG, United Kingdom

Location

The Clatterbridge Cancer Centre ( Site 0303)

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

sacituzumab govitecan; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: February 6, 2023
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): August 23, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

GR (3); IT (7); LA (4); IL (5); RO (6); GB (4); BR (6); JP (20); PL (7); CN (35); AU (3); PH (3); TU (8); LI (2); US (16); ES (2); CA (5); MY (3); PE (8); TW (7); TH (6); DE (7); CL (2); KR (5); ME (6)