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RECRUITING
NCT06801834
PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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 overall survival (OS).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

695

Start Date

2025-04-04

Completion Date

2029-10

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab Govitecan (SG)

Administered intravenously

DRUG

Topotecan

Administered intravenously

DRUG

Amrubicin (Japan only)

Administered intravenously

DRUG

Lurbinectedin (regions/countries where approved and available)

Administered intravenously

Locations (219)

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

And 119 more locations on ClinicalTrials.gov