RECRUITING Phase 3 ClinicalTrials.gov

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT06801834

Registry updated: 2026-10-20

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Description

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).

Interventions

Sacituzumab Govitecan (SG) (Drug)
Administered intravenously
Topotecan (Drug)
Administered intravenously
Amrubicin (Japan only) (Drug)
Administered intravenously
Lurbinectedin (regions/countries where approved and available) (Drug)
Administered intravenously

Eligibility criteria

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.

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Locations

Alaska Oncology and Hematology — Anchorage, Alaska, United States
Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States
Los Angeles Cancer Network — Anaheim, California, United States
Boca Raton Regional — Miami, Florida, United States
Hope and Healing Cancer Services — Hinsdale, Illinois, United States
Southern Illinois University School of Medicine — Springfield, Illinois, United States
Springfield Clinic — Springfield, Illinois, United States
Parkview Research Center — Fort Wayne, Indiana, United States
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie — Muncie, Indiana, United States
Northwest Cancer Centers — Dyer, Kentucky, United States
St. Claire Regional Medical Ce — Morehead, Kentucky, United States
New Mexico Oncology Hematology Consultants, Ltd — Albuquerque, New Mexico, United States
University Hospitals Seidman Cancer Center — Sandusky, Ohio, United States
Taylor Cancer Research Foundation — Toledo, Ohio, United States
Spoknwrd Clinical Trials Inc. — Easton, Pennsylvania, United States
Hendrick Health System — Abilene, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
Texas Oncology - San Antonio — New Braunfels, Texas, United States
The University of Texas Health Science Center at Tyler — Tyler, Texas, United States
Gundersen Health System — West Salem, Wisconsin, United States
Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires) — Buenos Aires, Argentina
Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata — Buenos Aires, Argentina
Centro Oncologico de Excelencia (San Juan) — San Juan, Argentina
Centro Médico San Roque — San Miguel de Tucumán, Argentina
Sanatorio Parque SA — Santa Fe, Argentina
Cancer Care Wollongong — New South Wales, New South Wales, Australia
Metro North HHS (The Prince Charles Hospital) — Queensland, Queensland, Australia
Gold Coast University Hospital — Southport, Queensland, Australia
Cancer Research SA — Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
Grand Hopital de Charleroi — Charleroi, Belgium
Jessa Ziekenhuis — Hasselt, Belgium
Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1 — Liège, Belgium
AZ Delta — Roeselare, Belgium
Vitaz — Sint-Niklaas, Belgium
Instituto do Cancer do Ceara — Fortaleza Ceara, Brazil
Hospital de Caridade de Ijui — Ijuí, Brazil
Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa Clinica — Natal, Brazil
Hospital Mae de Deus — Porto Alegre, Brazil
Hospital Sao Lucas da PUC Rio Grande do Sul — Porto Alegre, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira — Recife Pernambuco, Brazil
Grupo Oncoclínicas — Santa Lúcia, Brazil
Centro de Estudos e Pesquisa de Hematologia e Oncologia — Santo André, Brazil
Instituto Hemomed Oncologia e Hematologia — São Paulo, Brazil
Fundação Pio XII - Hospital de Amor — São Paulo, Brazil
HB Onco — São Paulo, Brazil
Hospital Amaral Carvalho — São Paulo, Brazil
Royal Victoria Regional Health Centre — Barrie, Canada
Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Canada
McGill University — Montreal, Canada
CISSS BSL / Hopital regional de Rimouski — Rimouski, Canada
Sunnybrook Health Sciences Centre — Toronto, Canada
Beijing Cancer Hospital — Beijing, China
Jilin Cancer Hospital — Changchun, China
Sichuan Cancer Hospital — Chengdu, China
Chongqing University Cancer Hospital — Chongqing, China
Fujian Medical University Union Hospital — Fuzhou, China
Sun Yat-sen University Cancer Center — Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China
Zhejiang Cancer Hospital — Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China
Harbin Medical University Cancer Hospital — Harbin, China
The Second Affiliated Hospital of Nanchang University — Jiangxi, China
Affiliated Cancer Hospital of Shandong First Medical University — Jinan, China
The Second Affiliated Hospital of Kunming Medical University — Kunming, China
Linyi Cancer Hospital — Linyi, China
The First Affiliated Hospital of Nanchang University — Nanchang, China
Jiangsu Cancer Hospital — Nanjing, China
Shanghai Chest Hospital — Shanghai, China
Shanghai East Hospital — Shanghai, China
Fudan University Shanghai Cancer Center — Shanghai, China
Shanxi Provincial Cancer Hospital — Shanxi, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, China
Tianjin Medical University Cancer Institute & Hospital — Tianjin, China
Weifang No.2 People's Hospital — Weifang, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China
The First Affiliated Hospital of Xiamen University — Xiamen, China
The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, China
Northern Jiangsu People's Hospital — Yangzhou, China
Henan Provincial Cancer Hospital — Zhengzhou, China
CHU Angers - Hôpital Larrey — Angers, France
Centre Hospitalier Intercommunal de Créteil — Créteil, France
CHU Grenoble Alpes - Hopital Albert Michallon — La Tronche, France
Hôpital Lyon Sud - Hospices Civils de Lyon — Lyon, France
Assistance Publique - Hopitaux de Marseille, Hopital Nord — Marseille, France
Hopital Tenon - Assistance Publique Hopitaux de Paris — Paris, France
Institut Curie — Paris, France
Hopital Haut-Leveque — Pessac, France
CHU Rennes - Hopital Pontchaillou — Rennes, France
Centre Hospitalier Universitaire de Nantes — Saint-Herblain, France
Hopital Saint Joseph - Paris — Saint-Mandé, France
CHU Strasbourg - Nouvel Hopital Civil — Strasbourg, France
Vivantes Klinikum Neukoelln, — Berlin, Germany
Charité Universitatsmedizin Berlin — Berlin, Germany
Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische Onkologie — Bochum, Germany
Klinikum Chemnitz gGmbH — Chemnitz, Germany
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and Pneumologie — Esslingen am Neckar, Germany
UKE Hamburg-Eppendorf fur Onkologie — Hamburg, Germany
Katholisches Marienkrankenhaus gGmbH — Hamburg, Germany
Fachklinik Loewenstein — Löwenstein, Germany
Johannes Wesling Klinikum Minden — Minden, Germany
LMU-Campus Innenstadt — Munich, Germany
Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology Department — Athens, Greece
Henry Dunant Hospital Center, 4th Oncology Clinic — Athens, Greece
Metropolitan Hospital — Athens, Greece
University General Hospital of Larissa Department of Medical Oncology — Larissa, Greece
University General Hospital of Patras, Division of Oncology — Rio, Greece
St Luke's Hospital Oncology Department, Panorama — Thessaloniki, Greece
Interbalkan Hospital of Thessaloniki — Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz, Onkoradiologiai Kozpont — Kecskemét, Hungary
Soroka Medical Center — Beersheba, Israel
Rambam Health Care Campus — Haifa, Israel
Hadassah Medical Center — Jerusalem, Israel
Meir Medical Center — Kfar Saba, Israel
Galilee Medical Center — Naharyia, Israel
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano — Aviano, Italy
IRCCS Candiolo - Istituto di Ricerca — Candiolo, Italy
Ospedale San Luca - Lucca — Lucca, Italy
IRCCS Ospedale San Raffaele — Milan, Italy
ASST - Grande Ospedale Metropolitano Niguarda — Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples — Naples, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale — Naples, Italy
Azienda Sanitaria Territoriale Pesaro e Urbino (AST) — Pesaro, Italy
Casa di cura Pederzoli — Peschiera del Garda, Italy
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri — Roma, Italy
Universita Cattolica del Sacro Cuore — Roma, Italy
Asst Ovest Milanese - Ospedale Nuovo Di Legnano — Treviglio, Italy
Nagoya University Hospital — Aichi, Japan
National Cancer Center Hospital East — Chiba, Japan
Shikoku Cancer Center — Ehime, Japan
Kyushu University Hospital — Fukuoka, Japan
Kurume University Hospital — Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Japan
Hyogo Cancer Center — Hyōgo, Japan
Kanagawa Cancer Center — Kanagawa, Japan
Kobe City Medical Center General Hospital — Kobe, Japan
Sendai Kousei Hospital — Miyagi, Japan
Niigata University Medical & Dental Hospital — Nigata-shi, Japan
Okayama University Hospital — Okayama, Japan
Osaka City General Hospital — Osaka, Japan
Kansai Medical University Hospital — Osaka, Japan
Kindai University Hospital — Osaka, Japan
National Hospital Organization Kinki Chuo Chest Medical Center — Osaka, Japan
Saitama Prefectural Cancer Center — Saitama, Japan
Juntendo University School of Medicine Juntendo Clinic — Tokyo, Japan
Nippon Medical School (all Hospitals) — Tokyo, Japan
The Cancer Institute Hospital of JFCR — Tokyo, Japan
Pantai Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
Beacon Hospital — Kuala Selangor, Malaysia
Sunway Medical Centre — Kuala Selangor, Malaysia
Sarawak General Hospital — Kuching, Malaysia
University Malaya Medical Centre — Lembah Pantai, Malaysia
Amsterdam UMC, Locatie VUMC — Amsterdam, Netherlands
Zuyderland Medisch Centrum — Heerlen, Netherlands
Frisius MC location Leeuwarden — Leeuwarden, Netherlands
Maastricht University Medical Center — Maastricht, Netherlands
Sint Antonius Ziekenhuis — Utrecht, Netherlands
Haukeland University hospital — Bergen, Norway
Seksjon for kreftbehandling, Drammen Hospital — Drammen, Norway
Oslo University Hospital — Oslo, Norway
Uniwersytet Medyczny w Lodzi — Lodz, Poland
Poznan University of Medical Sciences — Poznan, Poland
Podkarpackie Centrum Onkologii Rzeszow — Rzeszów, Poland
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach — Siedlce, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku — Stupsk, Poland
Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Warsaw, Poland
Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu — Bucharest, Romania
Spitalul Clinic Coltea — Bucharest, Romania
S.C Radiotherapy Center Cluj S.R.L — Cluj-Napoca, Romania
S.C Centrul de Oncologie S.F Nectarie SRL — Craiova, Romania
Institul Regional de Oncologie lasi; — Iași, Romania
S.C Ovidius Clinical Hospital S.R.L — Ovidiu, Romania
Spitalul Municipal Ploiesti — Ploieşti, Romania
S.C Oncomed S.R.L — Timișoara, Romania
Samsung Changwon Hospital — Changwon-Si, South Korea
Chonnam National University Hwasun Hospital — Gwangju, South Korea
Korea University Anam Hospital — Seongbuk-Gu, South Korea
Seoul National University Bundang Hospital — Seongnam, South Korea
Kangbuk Samsung Hospital — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
Yonsei University Severance Hospital — Seoul, South Korea
Gyeongsang National University Hospital — Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital — Suwon, South Korea
Ulsan University Hospital — Ulsan, South Korea
Complejo Hospitalario Universitario A Coruña — A Coruña, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
CEIC - Hospital Clinic i Provincial de Barcelona — Barcelona, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i Pujol — Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals — Barcelona, Spain
Hospital Universitario Reina Sofia — Córdoba, Spain
Institut Catala d'Oncologia Girona — Girona, Spain
Complejo Hospitalario de Jaén — Jaén, Spain
Complejo Hospitalario Universitario Insular Materno-Infantil — Las Palmas de Gran Canaria, Spain
Hospital General Universitario Gregorio Maranon — Madrid, Spain
Hospital Universitario Ramon y Cajal — Madrid, Spain
Facultad de Medicina. Universidad Complutense de Madrid — Madrid, Spain
Hospital Quironsalud Malaga — Málaga, Spain
Hospital Universitario Virgen de Valme Sevilla — Seville, Spain
Hospital Universitario Virgen de Valme — Seville, Spain
Hospital Clínico Universitario de Valencia — Valencia, Spain
Hospital Universitari i Politecnic La Fe — Valencia, Spain
Changhua Christian Hospital — Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Cheng Kung University Hospital — Tainan, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
National Taiwan University Cancer Center — Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou — Taoyuan City, Taiwan
The Christie NHS Foundation Trust — Manchester, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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