Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)
August 10, 2026 updated by: Gilead Sciences
A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).
The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
695
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gilead Clinical Study Information Cente
- Phone Number: 1-833-445-3230 (GILEAD-0)
- Email: GileadClinicalTrials@gilead.com
Study Locations
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Buenos Aires, Argentina, 1280
- Recruiting
- Hospital Británico de Buenos Aires
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Buenos Aires, Argentina
- Recruiting
- Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata
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Buenos Aires, Argentina, C1426ANZ
- Recruiting
- Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires)
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San Juan, Argentina
- Recruiting
- Centro Oncologico de Excelencia (San Juan)
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San Miguel de Tucumán, Argentina, T4000IAN
- Recruiting
- Centro Medico San Roque
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Santa Fe, Argentina, 2000
- Recruiting
- Sanatorio Parque SA
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New South Wales
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New South Wales, New South Wales, Australia, 2500
- Recruiting
- Cancer Care Wollongong
-
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Queensland
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Queensland, Queensland, Australia, 4006
- Recruiting
- Metro North HHS (The Prince Charles Hospital)
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Southport, Queensland, Australia, 4215
- Recruiting
- Gold Coast University Hospital
-
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South Australia
-
Adelaide, South Australia, Australia, 5000
- Recruiting
- Cancer Research SA
-
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Victoria
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Fitzroy, Victoria, Australia, 3065
- Recruiting
- St Vincent's Hospital Melbourne
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Recruiting
- Sir Charles Gairdner Hospital
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-
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-
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Charleroi, Belgium, 6000
- Recruiting
- Grand Hôpital de Charleroi
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Hasselt, Belgium, 3500
- Recruiting
- Jessa Ziekenhuis
-
Liège, Belgium, 4000
- Recruiting
- Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1
-
Roeselare, Belgium, 8800
- Recruiting
- AZ Delta
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Sint-Niklaas, Belgium, 9100
- Recruiting
- VITAZ
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-
-
-
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Fortaleza Ceara, Brazil, 60430-230
- Recruiting
- Instituto do Câncer do Ceará
-
Ijuí, Brazil, 98700-000
- Recruiting
- Hospital de Caridade de Ijui
-
Natal, Brazil, 59062-000
- Recruiting
- Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa Clinica
-
Porto Alegre, Brazil, 90110-270
- Recruiting
- Hospital Mae de Deus
-
Porto Alegre, Brazil, 90610-000
- Recruiting
- Hospital Sao Lucas da PUC Rio Grande do Sul
-
Recife Pernambuco, Brazil, 50070-550
- Recruiting
- IMIP - Instituto de Medicina Integral Professor Fernando Figueira
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Santa Lúcia, Brazil, 30360-680
- Recruiting
- Grupo Oncoclínicas
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Santo André, Brazil, 09060-650
- Recruiting
- Centro de Estudos e Pesquisa de Hematologia e Oncologia
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São Paulo, Brazil, 01227-200
- Recruiting
- Instituto Hemomed Oncologia e Hematologia
-
São Paulo, Brazil, 14784400
- Recruiting
- Fundação Pio XII - Hospital de Amor
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São Paulo, Brazil, 15090-000
- Recruiting
- HB Onco
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São Paulo, Brazil, 17210-080
- Recruiting
- Hospital Amaral Carvalho
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Barrie, Canada, L4M 6M2
- Recruiting
- Royal Victoria Regional Health Centre
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Hamilton, Canada, L8V 1C3
- Recruiting
- Hamilton Health Sciences - Juravinski Cancer Centre
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Montreal, Canada, H4A 3J1
- Recruiting
- McGill University
-
Rimouski, Canada, G5L 5T1
- Recruiting
- CISSS BSL / Hopital regional de Rimouski
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Toronto, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
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Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
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Changchun, China, 130012
- Recruiting
- Jilin Cancer Hospital
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Chengdu, China, 610041
- Recruiting
- Sichuan Cancer hospital
-
Chongqing, China, 404100
- Recruiting
- Chongqing University Cancer Hospital
-
Fuzhou, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
-
Guangzhou, China, 510080
- Recruiting
- The First Affiliated Hospital, Sun Yat-sen University
-
Guangzhou, China, 130012
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Hangzhou, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, China, 310009
- Recruiting
- The Second Affiliated hospital of Zhejiang University school of medicine
-
Hangzhou, China, 310000
- Recruiting
- Zhejiang Cancer Hospital
-
Hangzhou, China, 552440
- Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine
-
Harbin, China, 150081
- Recruiting
- Harbin Medical University Cancer Hospital
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Jiangxi, China, 330008
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Jinan, China, 250021
- Recruiting
- Affiliated Cancer Hospital of Shandong First Medical University
-
Kunming, China, 650000
- Recruiting
- The Second Affiliated Hospital of Kunming Medical University
-
Linyi, China, 276000
- Recruiting
- LinYi Cancer Hospital
-
Nanchang, China, 330019
- Recruiting
- The First Affiliated Hospital of Nanchang University
-
Nanjing, China, 210009
- Recruiting
- Jiangsu Cancer Hospital
-
Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
-
Shanghai, China, 200030
- Recruiting
- Shanghai Chest Hospital
-
Shanghai, China, 200123
- Recruiting
- Shanghai East Hospital
-
Shanxi, China, 030013
- Recruiting
- Shanxi Provincial Cancer Hospital
-
Shenzhen, China
- Recruiting
- Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
-
Tianjin, China, 300181
- Recruiting
- Tianjin Medical University Cancer Institute & Hospital
-
Weifang, China, 261041
- Recruiting
- Weifang NO.2 People's Hospital
-
Wuhan, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
-
Wuhan, China, 430030
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Xi'an, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xiamen, China, 361003
- Recruiting
- The First Affiliated Hospital of Xiamen University
-
Xinxiang, China, 453100
- Recruiting
- The First Affiliated Hospital of Xinxiang Medical University
-
Yangzhou, China, 225001
- Recruiting
- Northern Jiangsu People's Hospital
-
Zhengzhou, China, 450008
- Recruiting
- Henan Provincial Cancer Hospital
-
-
-
-
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Angers, France, 49933
- Recruiting
- CHU Angers - Hôpital Larrey
-
Créteil, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Creteil
-
La Tronche, France, 38700
- Recruiting
- CHU Grenoble Alpes - Hôpital Albert Michallon
-
Lyon, France, 69003
- Recruiting
- Hôpital Lyon Sud - Hospices Civils de Lyon
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Marseille, France, 13005
- Recruiting
- Assistance Publique - Hopitaux de Marseille, Hopital Nord
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Paris, France, 75248
- Recruiting
- Institut Curie
-
Paris, France, 75020
- Recruiting
- Hopital Tenon - Assistance Publique Hopitaux de Paris
-
Pessac, France, 33604
- Recruiting
- Hôpital Haut-Lévêque
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Rennes, France, 35033
- Recruiting
- CHU Rennes - Hopital Pontchaillou
-
Saint-Herblain, France, 44805
- Recruiting
- Centre Hospitalier Universitaire De Nantes
-
Saint-Mandé, France, 94160
- Recruiting
- Hopital Saint Joseph - Paris
-
Strasbourg, France, 67091
- Recruiting
- CHU Strasbourg - Nouvel Hopital Civil
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-
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-
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Berlin, Germany, 13353
- Active, not recruiting
- Charité Universitätsmedizin Berlin
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Berlin, Germany, 12351
- Recruiting
- Vivantes Klinikum Neukoelln,
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Bochum, Germany, 44791
- Recruiting
- Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische Onkologie
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Chemnitz, Germany, 9113
- Recruiting
- Klinikum Chemnitz gGmbH
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Esslingen am Neckar, Germany, 73730
- Recruiting
- Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and Pneumologie
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Hamburg, Germany, 22087
- Recruiting
- Katholisches Marienkrankenhaus gGmbH
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Hamburg, Germany, 20251
- Recruiting
- UKE Hamburg-Eppendorf fur Onkologie
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Löwenstein, Germany, 74245
- Recruiting
- Fachklinik Loewenstein
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Minden, Germany, 32429
- Recruiting
- Johannes Wesling Klinikum Minden
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Munich, Germany, 80336
- Active, not recruiting
- LMU-Campus Innenstadt
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Athens, Greece, 185 47
- Recruiting
- Metropolitan Hospital
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Athens, Greece, 11522
- Recruiting
- Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology Department
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Athens, Greece, 11526
- Recruiting
- Henry Dunant Hospital Center, 4th Oncology Clinic
-
Larissa, Greece, 41110
- Recruiting
- University General Hospital of Larissa Department of Medical Oncology
-
Rio, Greece, 26500
- Recruiting
- University General Hospital of Patras, Division of Oncology
-
Thessaloniki, Greece, 552 36
- Recruiting
- St Luke's Hospital Oncology Department, Panorama
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Thessaloniki, Greece, 57001
- Recruiting
- Interbalkan Hospital of Thessaloniki
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Kecskemét, Hungary, 6000
- Recruiting
- Bacs-Kiskun Varmegyei Oktatokorhaz, Onkoradiologiai Kozpont
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-
-
-
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Beersheba, Israel, 84001
- Recruiting
- Soroka Medical Center
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Haifa, Israel, 3109601
- Recruiting
- Rambam Health Care Campus
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Jerusalem, Israel, 9112001
- Recruiting
- Hadassah Medical Center
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Kfar Saba, Israel, 44281
- Recruiting
- Meir Medical Center
-
Naharyia, Israel, 11111
- Recruiting
- Galilee Medical Center
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-
-
-
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Aviano, Italy, 33081
- Recruiting
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
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Candiolo, Italy, 10060
- Recruiting
- IRCCS Candiolo - Istituto di Ricerca
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Lucca, Italy, 55100
- Recruiting
- Ospedale San Luca - Lucca
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Milan, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
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Milan, Italy, 20162
- Recruiting
- ASST - Grande Ospedale Metropolitano Niguarda
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Naples, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
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Naples, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples
-
Pesaro, Italy, 61122
- Recruiting
- Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
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Peschiera del Garda, Italy, 37019
- Recruiting
- Casa di cura Pederzoli
-
Roma, Italy, 144
- Recruiting
- Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
-
Roma, Italy, 168
- Recruiting
- Universita Cattolica del Sacro Cuore
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Treviglio, Italy, 24047
- Active, not recruiting
- Asst Ovest Milanese - Ospedale Nuovo Di Legnano
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-
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Aichi, Japan, 466-8560
- Recruiting
- Nagoya University Hospital
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Chiba, Japan, 277-0882
- Recruiting
- National Cancer Center Hospital East
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Ehime, Japan, 791-0245
- Recruiting
- Shikoku Cancer Center
-
Fukuoka, Japan, 812-8582
- Recruiting
- Kyushu University Hospital
-
Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University Hospital
-
Hiroshima, Japan, 730-8518
- Recruiting
- Hiroshima City Hiroshima Citizens Hospital
-
Hyōgo, Japan, 673-8558
- Recruiting
- Hyogo Cancer Center
-
Kanagawa, Japan, 241-0815
- Recruiting
- Kanagawa Cancer Center
-
Kobe, Japan, 650-0047
- Recruiting
- Kobe City Medical Center General Hospital
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Miyagi, Japan, 981-0914
- Recruiting
- Sendai Kousei Hospital
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Nigata-shi, Japan, 9518520
- Recruiting
- Niigata University Medical & Dental Hospital
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Okayama, Japan, 700-8558
- Recruiting
- Okayama University Hospital
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Osaka, Japan, 534-0021
- Recruiting
- Osaka City General Hospital
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Osaka, Japan, 589-8511
- Recruiting
- Kindai University Hospital
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Osaka, Japan, 573-1191
- Recruiting
- Kansai Medical University Hospital
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Osaka, Japan, 591-8555
- Recruiting
- National Hospital Organization Kinki Chuo Chest Medical Center
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Saitama, Japan, 362-0806
- Recruiting
- Saitama Prefectural Cancer Center
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Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital Of JFCR
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Tokyo, Japan, 113-8431
- Recruiting
- Juntendo University School of Medicine Juntendo Clinic
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Tokyo, Japan, 113-8603
- Recruiting
- Nippon Medical School (all Hospitals)
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Kuala Lumpur, Malaysia, 59100
- Completed
- Pantai Hospital Kuala Lumpur
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Kuala Selangor, Malaysia, 46050
- Completed
- Beacon Hospital
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Kuala Selangor, Malaysia, 47500
- Completed
- Sunway Medical Centre
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Kuching, Malaysia, 93586
- Active, not recruiting
- Sarawak General Hospital
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Lembah Pantai, Malaysia, 59100
- Completed
- University Malaya Medical Centre
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-
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Amsterdam, Netherlands, 1081 HV
- Recruiting
- Amsterdam UMC, locatie VUmc
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Heerlen, Netherlands, 6419 PC
- Recruiting
- Zuyderland Medisch Centrum
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Leeuwarden, Netherlands, 8934 AD
- Recruiting
- Frisius MC location Leeuwarden
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Maastricht, Netherlands, 6229 HX
- Recruiting
- Maastricht University Medical Center
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Utrecht, Netherlands, 3543 AZ
- Recruiting
- Sint Antonius Ziekenhuis
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Bergen, Norway, 5009
- Recruiting
- Haukeland University Hospital
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Drammen, Norway, 3004
- Recruiting
- Seksjon for kreftbehandling, Drammen Hospital
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Oslo, Norway, 379
- Recruiting
- Oslo University Hospital
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Lodz, Poland, 90-302
- Recruiting
- Uniwersytet Medyczny w Lodzi
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Poznan, Poland, 60-693
- Recruiting
- Poznan University of Medical Sciences
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Rzeszów, Poland, 35-055
- Recruiting
- Podkarpackie Centrum Onkologii Rzeszow
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Siedlce, Poland, 08-110
- Recruiting
- Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
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Stupsk, Poland, 076-200
- Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
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Warsaw, Poland, 02-781
- Recruiting
- Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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-
-
-
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Bucharest, Romania, 30171
- Recruiting
- Spitalul Clinic Colțea
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Bucharest, Romania, 22328
- Recruiting
- Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu
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Cluj-Napoca, Romania, 407 280
- Recruiting
- S.C Radiotherapy Center Cluj S.R.L
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Craiova, Romania, 200347
- Recruiting
- S.C Centrul de Oncologie S.F Nectarie SRL
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Iași, Romania, 700483
- Recruiting
- Institul Regional de Oncologie lasi;
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Ovidiu, Romania
- Recruiting
- S.C Ovidius Clinical Hospital S.R.L
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Ploieşti, Romania, 100337
- Recruiting
- Spitalul Municipal Ploiesti
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Timișoara, Romania, 300239
- Recruiting
- S.C Oncomed S.R.L
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-
-
-
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Changwon-Si, South Korea
- Recruiting
- Samsung Changwon Hospital
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Gwangju, South Korea, 61469
- Recruiting
- Chonnam National University Hwasun Hospital
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Seongbuk-Gu, South Korea
- Recruiting
- Korea University Anam Hospital
-
Seongnam, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
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Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Seoul, South Korea, 06591
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, South Korea, 03181
- Recruiting
- Kangbuk Samsung Hospital
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Seoul, South Korea, 120-752
- Recruiting
- Yonsei University Severance Hospital
-
Seoul, South Korea, 52727
- Recruiting
- Gyeongsang National University Hospital
-
Suwon, South Korea, 16247
- Recruiting
- The Catholic University of Korea, St. Vincent's Hospital
-
Ulsan, South Korea, 44033
- Recruiting
- Ulsan University Hospital
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-
-
-
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A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruna
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spain, 08041
- Recruiting
- Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain, 08036
- Recruiting
- CEIC - Hospital Clinic i Provincial de Barcelona
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Barcelona, Spain, 08916
- Recruiting
- ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i Pujol
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Barcelona, Spain, 8906
- Active, not recruiting
- ICO l'Hospitalet - Hospital Duran i Reynals
-
Girona, Spain, 17007
- Recruiting
- Institut Catala d'Oncologia GIRONA
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Jaén, Spain, 23007
- Recruiting
- Complejo Hospitalario de Jaén
-
Las Palmas de Gran Canaria, Spain, 35016
- Recruiting
- Complejo Hospitalario Universitario Insular Materno-Infantil
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Maranon
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Madrid, Spain, 28041
- Recruiting
- Facultad de Medicina. Universidad Complutense de Madrid
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Málaga, Spain, 29010
- Recruiting
- Hospital Quironsalud Malaga
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Seville, Spain, 41014
- Recruiting
- Hospital Universitario Virgen de Valme
-
Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen de Valme Sevilla
-
Valencia, Spain, 46010
- Recruiting
- Hospital Clinico Universitario de Valencia
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Valencia, Spain, 46026
- Recruiting
- Hospital Universitari I Politècnic La Fe
-
-
-
-
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Changhua, Taiwan, 500-06
- Active, not recruiting
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 80756
- Active, not recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40705
- Active, not recruiting
- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10002
- Recruiting
- Taipei Veterans General Hospital
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Taipei, Taiwan, 112
- Active, not recruiting
- Koo Foundation Sun Yat-Sen Cancer Center
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Cancer Center
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Taoyuan City, Taiwan, 33305
- Completed
- Chang Gung Memorial Hospital, Linkou
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-
-
-
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
-
-
-
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Alaska
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Anchorage, Alaska, United States, 99508
- Recruiting
- Alaska Oncology and Hematology
-
-
Arkansas
-
Hot Springs, Arkansas, United States, 71913
- Recruiting
- Genesis Cancer and Blood Institute
-
-
California
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Anaheim, California, United States, 92801
- Recruiting
- Los Angeles Cancer Network
-
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Florida
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Miami, Florida, United States, 33143
- Recruiting
- Boca Raton Regional
-
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Illinois
-
Hinsdale, Illinois, United States, 60521
- Recruiting
- Hope and Healing Cancer Services
-
Springfield, Illinois, United States, 62702
- Recruiting
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Recruiting
- Springfield Clinic
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46845
- Recruiting
- Parkview Research Center
-
Muncie, Indiana, United States, 47303
- Recruiting
- IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
-
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Kentucky
-
Dyer, Kentucky, United States, 46311
- Recruiting
- Northwest Cancer Centers
-
Morehead, Kentucky, United States, 40351
- Recruiting
- St. Claire Regional Medical Ce
-
Owensboro, Kentucky, United States, 42303
- Not yet recruiting
- Owensboro Health Mitchell Memorial Cancer Center
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Maine
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Scarborough, Maine, United States, 04074
- Not yet recruiting
- MaineHealth Cancer Care
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- Not yet recruiting
- OptumCare Cancer Care
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Recruiting
- New Mexico Oncology Hematology Consultants, Ltd
-
-
Ohio
-
Sandusky, Ohio, United States, 44870
- Recruiting
- University Hospitals Seidman Cancer Center
-
Toledo, Ohio, United States, 43617
- Recruiting
- Taylor Cancer Research Foundation
-
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Pennsylvania
-
Easton, Pennsylvania, United States, 18045
- Recruiting
- Spoknwrd Clinical Trials Inc.
-
-
Texas
-
Abilene, Texas, United States, 79601
- Recruiting
- Hendrick Health System
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
New Braunfels, Texas, United States, 78130
- Recruiting
- Texas Oncology - San Antonio
-
Tyler, Texas, United States, 75708
- Recruiting
- The University of Texas Health Science Center at Tyler
-
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Wisconsin
-
West Salem, Wisconsin, United States, 54601
- Recruiting
- Gundersen Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- Histologically confirmed diagnosis of SCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
- Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
- Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
- If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
- If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.
Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy.
Refer to protocol for country-specific requirements for participants in China.
Key Exclusion Criteria:
- Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) < 30 days (independent of the immunotherapy maintenance).
- Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.
- Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group A: SG
Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle.
Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Administered intravenously
Other Names:
|
|
Experimental: Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle:
In Japan, participants assigned to Treatment Group B may alternatively receive: • Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle. Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met. |
Administered intravenously
Administered intravenously
Administered intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to 4.5 years
|
OS is defined as length of time from randomization until the date of death from any cause.
|
Up to 4.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Deterioration in Shortness of Breath Domain
Time Frame: Up to 4.5 years
|
Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.
|
Up to 4.5 years
|
|
Time to First Deterioration in Physical Functioning Domain
Time Frame: Up to 4.5 years
|
Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.
|
Up to 4.5 years
|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 4.5 years
|
TEAE is defined as any AEs occurred during the treatment-emergent period.
The treatment-emergent period is defined as the time period from the first dose of study treatment to the earlier of 30 days following the last dose of study treatment or the initiation of subsequent anticancer therapy.
|
First dose date up to 4.5 years
|
|
Percentage of Participants Experiencing Clinical Laboratory abnormalities
Time Frame: First dose date up to 4.5 years
|
Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.
|
First dose date up to 4.5 years
|
|
Progression-free Survival (PFS)
Time Frame: Up to 4.5 years
|
PFS is defined as the time from date of randomization until disease progression as assessed by investigator according to RECIST v1.1 or death from any cause, whichever comes first.
|
Up to 4.5 years
|
|
Objective Response Rate (ORR)
Time Frame: Up to 4.5 years
|
ORR is defined as the percentage of participants who have achieved a CR or PR as assessed by investigator according to RECIST v1.1.
|
Up to 4.5 years
|
|
Duration of Response (DOR)
Time Frame: Up to 4.5 years
|
DOR is defined as is measured from the time of first response (CR or PR) as assessed by investigator according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first
|
Up to 4.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Study Registration Dates
First Submitted
January 24, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
January 30, 2025
Study Record Updates
Last Update Posted (Actual)
August 12, 2026
Last Update Submitted That Met QC Criteria
August 10, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-600-6165
- 2024-515884-69 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.