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Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
NCT06801834 · Gilead Sciences
In plain English
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Official title
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)
About this study
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 objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).
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.
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.
* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 695 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-04
Estimated completion: 2029-10
Last updated: 2026-03-19
Interventions
Drug: Sacituzumab Govitecan (SG)Drug: TopotecanDrug: Amrubicin (Japan only)
Primary outcomes
- • Objective Response Rate (ORR) (Up to 4.5 years)
- • Overall Survival (OS) (Up to 4.5 years)
Sponsor
Gilead Sciences · industry
Contacts & investigators
ContactGilead Clinical Study Information Cente · contact · GileadClinicalTrials@gilead.com · 1-833-445-3230 (GILEAD-0)
InvestigatorGilead Study Director · study_director, Gilead Sciences
All locations (205)
Los Angeles Cancer NetworkRecruiting
Anaheim, California, United States
Boca Raton RegionalRecruiting
Miami, Florida, United States
Hope and Healing Cancer ServicesRecruiting
Hinsdale, Illinois, United States
Southern Illinois University School of MedicineRecruiting
Springfield, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Parkview Research CenterRecruiting
Fort Wayne, Indiana, United States
IU Health Ball Memorial Hospital and Physicians - Cancer Center - MuncieRecruiting
Muncie, Indiana, United States
Northwest Cancer CentersRecruiting
Dyer, Kentucky, United States
St. Claire Regional Medical CeRecruiting
Morehead, Kentucky, United States
New Mexico Oncology Hematology Consultants, LtdRecruiting
Albuquerque, New Mexico, United States
University Hospitals Seidman Cancer CenterRecruiting
Sandusky, Ohio, United States
Taylor Cancer Research FoundationRecruiting
Toledo, Ohio, United States
Spoknwrd Clinical Trials Inc.Recruiting
Easton, Pennsylvania, United States
Hendrick Health SystemRecruiting
Abilene, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Oncology - San AntonioRecruiting
New Braunfels, Texas, United States
The University of Texas Health Science Center at TylerRecruiting
Tyler, Texas, United States
Gundersen Health SystemRecruiting
West Salem, Wisconsin, United States
Hospital Britanico de Buenos AiresRecruiting
Buenos Aires, Argentina
Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires)Recruiting
Buenos Aires, Argentina
Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del PlataRecruiting
Buenos Aires, Argentina
Centro Oncologico de Excelencia (San Juan)Recruiting
San Juan, Argentina
Centro Médico San RoqueRecruiting
San Miguel de Tucumán, Argentina
Sanatorio Parque SARecruiting
Santa Fe, Argentina
Cancer Care WollongongRecruiting
New South Wales, New South Wales, Australia
Metro North HHS (The Prince Charles Hospital)Recruiting
Queensland, Queensland, Australia
Gold Coast University HospitalRecruiting
Southport, Queensland, Australia
Cancer Research SARecruiting
Adelaide, South Australia, Australia
St Vincent's Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Sir Charles Gairdner HospitalRecruiting
Nedlands, Western Australia, Australia
Grand Hopital de CharleroiRecruiting
Charleroi, Belgium
Jessa ZiekenhuisRecruiting
Hasselt, Belgium
Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1Recruiting
Liège, Belgium
AZ DeltaRecruiting
Roeselare, Belgium
VitazRecruiting
Sint-Niklaas, Belgium
Instituto do Cancer do CearaRecruiting
Fortaleza Ceara, Brazil
Hospital de Caridade de IjuiRecruiting
Ijuí, Brazil
Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa ClinicaRecruiting
Natal, Brazil
Hospital Mae de DeusRecruiting
Porto Alegre, Brazil
Hospital Sao Lucas da PUC Rio Grande do SulRecruiting
Porto Alegre, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando FigueiraRecruiting
Recife Pernambuco, Brazil
Grupo OncoclínicasRecruiting
Santa Lúcia, Brazil
Centro de Estudos e Pesquisa de Hematologia e OncologiaRecruiting
Santo André, Brazil
Instituto Hemomed Oncologia e HematologiaRecruiting
São Paulo, Brazil
Fundação Pio XII - Hospital de AmorRecruiting
São Paulo, Brazil
HB OncoRecruiting
São Paulo, Brazil
Hospital Amaral CarvalhoRecruiting
São Paulo, Brazil
Royal Victoria Regional Health CentreRecruiting
Barrie, Canada
Hamilton Health Sciences - Juravinski Cancer CentreRecruiting
Hamilton, Canada
McGill UniversityRecruiting
Montreal, Canada
CISSS BSL / Hopital regional de RimouskiRecruiting
Rimouski, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Canada
Beijing Cancer HospitalRecruiting
Beijing, China
Jilin Cancer HospitalRecruiting
Changchun, China
Sichuan Cancer HospitalRecruiting
Chengdu, China
Chongqing University Cancer HospitalRecruiting
Chongqing, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Guangzhou, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Hangzhou, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Jiangxi, China
Affiliated Cancer Hospital of Shandong First Medical UniversityRecruiting
Jinan, China
The Second Affiliated Hospital of Kunming Medical UniversityRecruiting
Kunming, China
Linyi Cancer HospitalRecruiting
Linyi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
Jiangsu Cancer HospitalRecruiting
Nanjing, China
Shanghai Chest HospitalRecruiting
Shanghai, China
Shanghai East HospitalRecruiting
Shanghai, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
Shanxi Provincial Cancer HospitalRecruiting
Shanxi, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterRecruiting
Shenzhen, China
Tianjin Medical University Cancer Institute & HospitalRecruiting
Tianjin, China
Weifang No.2 People's HospitalRecruiting
Weifang, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Xi'an, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, China
The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
Xinxiang, China
Northern Jiangsu People's HospitalRecruiting
Yangzhou, China
Henan Provincial Cancer HospitalRecruiting
Zhengzhou, China
CHU Angers - Hôpital LarreyRecruiting
Angers, France
Centre Hospitalier Intercommunal de CréteilRecruiting
Créteil, France
CHU Grenoble Alpes - Hopital Albert MichallonRecruiting
La Tronche, France
Hôpital Lyon Sud - Hospices Civils de LyonRecruiting
Lyon, France
Assistance Publique - Hopitaux de Marseille, Hopital NordRecruiting
Marseille, France
Hopital Tenon - Assistance Publique Hopitaux de ParisRecruiting
Paris, France
Institut CurieRecruiting
Paris, France
Hopital Haut-LevequeRecruiting
Pessac, France
CHU Rennes - Hopital PontchaillouRecruiting
Rennes, France
Centre Hospitalier Universitaire de NantesRecruiting
Saint-Herblain, France
Hopital Saint Joseph - ParisRecruiting
Saint-Mandé, France
CHU Strasbourg - Nouvel Hopital CivilRecruiting
Strasbourg, France
Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische OnkologieRecruiting
Bochum, Germany
Klinikum Chemnitz gGmbHRecruiting
Chemnitz, Germany
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and PneumologieRecruiting
Esslingen am Neckar, Germany
UKE Hamburg-Eppendorf fur OnkologieRecruiting
Hamburg, Germany
Katholisches Marienkrankenhaus gGmbHRecruiting
Hamburg, Germany
Johannes Wesling Klinikum MindenRecruiting
Minden, Germany
Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology DepartmentRecruiting
Athens, Greece
Henry Dunant Hospital Center, 4th Oncology ClinicRecruiting
Athens, Greece
Metropolitan HospitalRecruiting
Athens, Greece
University General Hospital of Larissa Department of Medical OncologyRecruiting
Larissa, Greece
University General Hospital of Patras, Division of OncologyRecruiting
Rio, Greece
St Luke's Hospital Oncology Department, PanoramaRecruiting
Thessaloniki, Greece
Interbalkan Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz, Onkoradiologiai KozpontRecruiting
Kecskemét, Hungary
Soroka Medical CenterRecruiting
Beersheba, Israel
Rambam Health Care CampusRecruiting
Haifa, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Galilee Medical CenterRecruiting
Naharyia, Israel
Fondazione IRCCS - Istituto Nazionale dei Tumori di MilanoRecruiting
Aviano, Italy
IRCCS Candiolo - Istituto di RicercaRecruiting
Candiolo, Italy
Ospedale San Luca - LuccaRecruiting
Lucca, Italy
ASST - Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale NaplesRecruiting
Naples, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. PascaleRecruiting
Naples, Italy
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)Recruiting
Pesaro, Italy
Casa di cura PederzoliRecruiting
Peschiera del Garda, Italy
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici OspitalieriRecruiting
Roma, Italy
Universita Cattolica del Sacro CuoreRecruiting
Roma, Italy
Nagoya University HospitalRecruiting
Aichi, Japan
Shikoku Cancer CenterRecruiting
Ehime, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Kurume University HospitalRecruiting
Fukuoka, Japan
Hiroshima City Hiroshima Citizens HospitalRecruiting
Hiroshima, Japan
Hyogo Cancer CenterRecruiting
Hyōgo, Japan
Kanagawa Cancer CenterRecruiting
Kanagawa, Japan
Kobe City Medical Center General HospitalRecruiting
Kobe, Japan
Sendai Kousei HospitalRecruiting
Miyagi, Japan
Niigata University Medical & Dental HospitalRecruiting
Nigata-shi, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Osaka City General HospitalRecruiting
Osaka, Japan
Kansai Medical University HospitalRecruiting
Osaka, Japan
Kindai University HospitalRecruiting
Osaka, Japan
National Hospital Organization Kinki Chuo Chest Medical CenterRecruiting
Osaka, Japan
Saitama Prefectural Cancer CenterRecruiting
Saitama, Japan
Juntendo University School of Medicine Juntendo ClinicRecruiting
Tokyo, Japan
Nippon Medical School (all Hospitals)Recruiting
Tokyo, Japan
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
Pantai Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
Beacon HospitalRecruiting
Kuala Selangor, Malaysia
Sunway Medical CentreRecruiting
Kuala Selangor, Malaysia
Sarawak General HospitalRecruiting
Kuching, Malaysia
University Malaya Medical CentreRecruiting
Lembah Pantai, Malaysia
Amsterdam UMC, Locatie VUMCRecruiting
Amsterdam, Netherlands
Zuyderland Medisch CentrumRecruiting
Heerlen, Netherlands
Frisius MC location LeeuwardenRecruiting
Leeuwarden, Netherlands
Maastricht University Medical CenterRecruiting
Maastricht, Netherlands
Sint Antonius ZiekenhuisRecruiting
Utrecht, Netherlands
Haukeland University hospitalRecruiting
Bergen, Norway
Seksjon for kreftbehandling, Drammen HospitalRecruiting
Drammen, Norway
Oslo University HospitalRecruiting
Oslo, Norway
Uniwersytet Medyczny w LodziRecruiting
Lodz, Poland
Poznan University of Medical SciencesRecruiting
Poznan, Poland
Podkarpackie Centrum Onkologii RzeszowRecruiting
Rzeszów, Poland
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w SiedlcachRecruiting
Siedlce, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w SłupskuRecruiting
Stupsk, Poland
Spitalul Clinic ColteaRecruiting
Bucharest, Romania
S.C Radiotherapy Center Cluj S.R.LRecruiting
Cluj-Napoca, Romania
S.C Centrul de Oncologie S.F Nectarie SRLRecruiting
Craiova, Romania
Institul Regional de Oncologie lasi;Recruiting
Iași, Romania
S.C Ovidius Clinical Hospital S.R.LRecruiting
Ovidiu, Romania
Spitalul Municipal PloiestiRecruiting
Ploieşti, Romania
S.C Oncomed S.R.LRecruiting
Timișoara, Romania
Samsung Changwon HospitalRecruiting
Changwon-Si, South Korea
Chonnam National University Hwasun HospitalRecruiting
Gwangju, South Korea
Korea University Anam HospitalRecruiting
Seongbuk-Gu, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, South Korea
Kangbuk Samsung HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
Seoul, South Korea
Yonsei University Severance HospitalRecruiting
Seoul, South Korea
Gyeongsang National University HospitalRecruiting
Seoul, South Korea
The Catholic University of Korea, St. Vincent's HospitalRecruiting
Suwon, South Korea
Ulsan University HospitalRecruiting
Ulsan, South Korea
Complejo Hospitalario Universitario A CoruñaRecruiting
A Coruña, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
CEIC - Hospital Clinic i Provincial de BarcelonaRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i PujolRecruiting
Barcelona, Spain
Institut Catala d'Oncologia GironaRecruiting
Girona, Spain
Complejo Hospitalario de JaénRecruiting
Jaén, Spain
Complejo Hospitalario Universitario Insular Materno-InfantilRecruiting
Las Palmas de Gran Canaria, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Facultad de Medicina. Universidad Complutense de MadridRecruiting
Madrid, Spain
Hospital Quironsalud MalagaRecruiting
Málaga, Spain
Hospital Universitario Virgen de Valme SevillaRecruiting
Seville, Spain
Hospital Universitario Virgen de ValmeRecruiting
Seville, Spain
Hospital Clínico Universitario de ValenciaRecruiting
Valencia, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
National Taiwan University Cancer CenterRecruiting
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
Taipei, Taiwan
Chang Gung Memorial Hospital, LinkouRecruiting
Taoyuan, Taiwan
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom