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)
Status: Recruiting
Location: See all (103) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Indiana
Parkview Research Center
RECRUITING
Fort Wayne
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
RECRUITING
Muncie
Kentucky
Northwest Cancer Centers
RECRUITING
Dyer
Ohio
University Hospitals Seidman Cancer Center
RECRUITING
Sandusky
Taylor Cancer Research Foundation
RECRUITING
Toledo
Pennsylvania
Spoknwrd Clinical Trials Inc.
RECRUITING
Easton
Texas
Hendrick Health System
RECRUITING
Abilene
MD Anderson Cancer Center
RECRUITING
Houston
The University of Texas Health Science Center at Tyler
RECRUITING
Tyler
Other Locations
Australia
Cancer Research SA
RECRUITING
Adelaide
St Vincent's Hospital Melbourne
RECRUITING
Fitzroy
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Cancer Care Wollongong
RECRUITING
New South Wales
Metro North HHS (The Prince Charles Hospital)
RECRUITING
Queensland
Gold Coast University Hospital
RECRUITING
Southport
Canada
McGill University
RECRUITING
Montreal
China
Jilin Cancer Hospital
RECRUITING
Changchun
Sichuan Cancer Hospital
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The Second Affiliated Hospital of Nanchang University
RECRUITING
Jiangxi
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Linyi Cancer Hospital
RECRUITING
Linyi
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Weifang No.2 People's Hospital
RECRUITING
Weifang
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
France
CHU Angers - Hôpital Larrey
RECRUITING
Angers
Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Institut Curie
RECRUITING
Paris
Hopital Haut-Leveque
RECRUITING
Pessac
Germany
Katholisches Marienkrankenhaus gGmbH
RECRUITING
Hamburg
Johannes Wesling Klinikum Minden
RECRUITING
Minden
Israel
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Galilee Medical Center
RECRUITING
Naharyia
Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
RECRUITING
Aviano
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Naples
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples
RECRUITING
Naples
Casa di cura Pederzoli
RECRUITING
Peschiera Del Garda
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
RECRUITING
Roma
Universita Cattolica del Sacro Cuore
RECRUITING
Roma
Japan
Kurume University Hospital
RECRUITING
Fukuoka
Kyushu University Hospital
RECRUITING
Fukuoka
Hyogo Cancer Center
RECRUITING
Hyōgo
Kanagawa Cancer Center
RECRUITING
Kanagawa
Kobe City Medical Center General Hospital
RECRUITING
Kobe
Sendai Kousei Hospital
RECRUITING
Miyagi
Okayama University Hospital
RECRUITING
Okayama
Kansai Medical University Hospital
RECRUITING
Osaka
National Hospital Organization Kinki Chuo Chest Medical Center
RECRUITING
Osaka
Osaka City General Hospital
RECRUITING
Osaka
Saitama Prefectural Cancer Center
RECRUITING
Saitama
Nippon Medical School (all Hospitals)
RECRUITING
Tokyo
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Malaysia
Pantai Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
Beacon Hospital
RECRUITING
Kuala Selangor
Sunway Medical Centre
RECRUITING
Kuala Selangor
Sarawak General Hospital
RECRUITING
Kuching
University Malaya Medical Centre
RECRUITING
Lembah Pantai
Netherlands
Amsterdam UMC, Locatie VUMC
RECRUITING
Amsterdam
Sint Antonius Ziekenhuis
RECRUITING
Utrecht
Poland
Uniwersytet Medyczny w Lodzi
RECRUITING
Lodz
Poznan University of Medical Sciences
RECRUITING
Poznan
Podkarpackie Centrum Onkologii Rzeszow
RECRUITING
Rzeszów
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
RECRUITING
Siedlce
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
RECRUITING
Stupsk
Republic of Korea
Samsung Changwon Hospital
RECRUITING
Changwon-si
Chonnam National University Hwasun Hospital
RECRUITING
Gwangju
Korea University Anam Hospital
RECRUITING
Seongbuk-gu
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Gyeongsang National University Hospital
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Yonsei University Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Spain
Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
CEIC - Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Institut Catala d'Oncologia Girona
RECRUITING
Girona
Complejo Hospitalario de Jaén
RECRUITING
Jaén
Facultad de Medicina. Universidad Complutense de Madrid
RECRUITING
Madrid
Hospital Universitario Virgen de Valme
RECRUITING
Seville
Hospital Universitario Virgen de Valme Sevilla
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
National Taiwan University Cancer Center
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan
Contact Information
Primary
Gilead Clinical Study Information Cente
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2025-04-04
Estimated Completion Date: 2029-10
Participants
Target number of participants: 695
Treatments
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.
Experimental: Treatment Group B: Topotecan or Amrubicin (Japan only)
Participants assigned to treatment group B will receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle.~Japan participants assigned to treatment group B will have the option to receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle, or Amrubicin 40 mg/m\^2 daily on Days 1 to 3 of a 21-day cycle.~Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences