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NCT06801834PHASE3Recruiting

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

Gilead Sciences

Start Date

4/4/2025

Completion Date

10/1/2029

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sacituzumab Govitecan (SG)

DRUG

Topotecan

DRUG

Amrubicin (Japan only)

DRUG

Lurbinectedin (regions/countries where approved and available)

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Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Locations

Genesis Cancer and Blood Institute

Hot Springs, Arkansas 71913

United States

Los Angeles Cancer Network

Anaheim, California 92801

United States

Boca Raton Regional

Miami, Florida 33143

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Springfield Clinic

Springfield, Illinois 62702

United States

Parkview Research Center

Fort Wayne, Indiana 46845

United States

IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie

Muncie, Indiana 47303

United States

Northwest Cancer Centers

Dyer, Kentucky 46311

United States

St. Claire Regional Medical Ce

Morehead, Kentucky 40351

United States

Maine Health Cancer Care

Scarborough, Maine 04074

United States

Optum Care Cancer Care

Las Vegas, Nevada 89102

United States

New Mexico Oncology Hematology Consultants, Ltd

Albuquerque, New Mexico 87109

United States

University Hospitals Seidman Cancer Center

Sandusky, Ohio 44870

United States

Taylor Cancer Research Foundation

Toledo, Ohio 43617

United States

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania 18045

United States

Hendrick Health System

Abilene, Texas 79601

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - San Antonio

New Braunfels, Texas 78130

United States

The University of Texas Health Science Center at Tyler

Tyler, Texas 75708

United States

Gundersen Health System

West Salem, Wisconsin 54601

United States

Hospital Britanico de Buenos Aires

Buenos Aires, 1280

Argentina

Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires)

Buenos Aires, C1426ANZ

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, T4000IAN

Argentina

Sanatorio Parque SA

Santa Fe, 2000

Argentina

Cancer Care Wollongong

New South Wales, New South Wales 2500

Australia

Metro North HHS (The Prince Charles Hospital)

Queensland, Queensland 4006

Australia

Gold Coast University Hospital

Southport, Queensland 4215

Australia

Cancer Research SA

Adelaide, South Australia 5000

Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia 6009

Australia

Grand Hopital de Charleroi

Charleroi, 6000

Belgium

Jessa Ziekenhuis

Hasselt, 3500

Belgium

Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1

Liège, 4000

Belgium

AZ Delta

Roeselare, 8800

Belgium

Vitaz

Sint-Niklaas, 9100

Belgium

Instituto do Cancer do Ceara

Fortaleza Ceara, 60430-230

Brazil

Hospital de Caridade de Ijui

Ijuí, 98700-000

Brazil

Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa Clinica

Natal, 59062-000

Brazil

Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Hospital Sao Lucas da PUC Rio Grande do Sul

Porto Alegre, 90610-000

Brazil

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Recife Pernambuco, 50070-550

Brazil

Grupo Oncoclínicas

Santa Lúcia, 30360-680

Brazil

Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, 09060-650

Brazil

Instituto Hemomed Oncologia e Hematologia

São Paulo, 01227-200

Brazil

Fundação Pio XII - Hospital de Amor

São Paulo, 14784400

Brazil

HB Onco

São Paulo, 15090-000

Brazil

Hospital Amaral Carvalho

São Paulo, 17210-080

Brazil

Royal Victoria Regional Health Centre

Barrie, L4M 6M2

Canada

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, L8V 1C3

Canada

McGill University

Montreal, H4A 3J1

Canada

CISSS BSL / Hopital regional de Rimouski

Rimouski, G5L 5T1

Canada

Sunnybrook Health Sciences Centre

Toronto, M4N 3M5

Canada

Beijing Cancer Hospital

Beijing, 100142

China

Jilin Cancer Hospital

Changchun, 130012

China

Sichuan Cancer Hospital

Chengdu, 610041

China

Chongqing University Cancer Hospital

Chongqing, 404100

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

Sun Yat-sen University Cancer Center

Guangzhou, 130012

China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080

China

Zhejiang Cancer Hospital

Hangzhou, 310000

China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009

China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, 310016

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, 552440

China

Harbin Medical University Cancer Hospital

Harbin, 150081

China

The Second Affiliated Hospital of Nanchang University

Jiangxi, 330008

China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, 250021

China

The Second Affiliated Hospital of Kunming Medical University

Kunming, 650000

China

Linyi Cancer Hospital

Linyi, 276000

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330019

China

Jiangsu Cancer Hospital

Nanjing, 210009

China

Shanghai Chest Hospital

Shanghai, 200030

China

Shanghai East Hospital

Shanghai, 200123

China

Fudan University Shanghai Cancer Center

Shanghai,

China

Shanxi Provincial Cancer Hospital

Shanxi, 030013

China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen,

China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300181

China

Weifang No.2 People's Hospital

Weifang, 261041

China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030

China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030

China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061

China

The First Affiliated Hospital of Xiamen University

Xiamen, 361003

China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, 453100

China

Northern Jiangsu People's Hospital

Yangzhou, 225001

China

Henan Provincial Cancer Hospital

Zhengzhou, 450008

China

CHU Angers - Hôpital Larrey

Angers, 49933

France

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000

France

CHU Grenoble Alpes - Hopital Albert Michallon

La Tronche, 38700

France

Hôpital Lyon Sud - Hospices Civils de Lyon

Lyon, 69003

France

Assistance Publique - Hopitaux de Marseille, Hopital Nord

Marseille, 13005

France

Hopital Tenon - Assistance Publique Hopitaux de Paris

Paris, 75020

France

Institut Curie

Paris, 75248

France

Hopital Haut-Leveque

Pessac, 33604

France

CHU Rennes - Hopital Pontchaillou

Rennes, 35033

France

Centre Hospitalier Universitaire de Nantes

Saint-Herblain, 44805

France

Hopital Saint Joseph - Paris

Saint-Mandé, 94160

France

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091

France

Vivantes Klinikum Neukoelln,

Berlin, 12351

Germany

Charité Universitatsmedizin Berlin

Berlin, 13353

Germany

Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische Onkologie

Bochum, 44791

Germany

Klinikum Chemnitz gGmbH

Chemnitz, 9113

Germany

Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and Pneumologie

Esslingen am Neckar, 73730

Germany

UKE Hamburg-Eppendorf fur Onkologie

Hamburg, 20251

Germany

Katholisches Marienkrankenhaus gGmbH

Hamburg, 22087

Germany

Fachklinik Loewenstein

Löwenstein, 74245

Germany

Johannes Wesling Klinikum Minden

Minden, 32429

Germany

LMU-Campus Innenstadt

Munich, 80336

Germany

Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology Department

Athens, 11522

Greece

Henry Dunant Hospital Center, 4th Oncology Clinic

Athens, 11526

Greece

Metropolitan Hospital

Athens, 185 47

Greece

University General Hospital of Larissa Department of Medical Oncology

Larissa, 41110

Greece

University General Hospital of Patras, Division of Oncology

Rio, 26500

Greece

St Luke's Hospital Oncology Department, Panorama

Thessaloniki, 552 36

Greece

Interbalkan Hospital of Thessaloniki

Thessaloniki, 57001

Greece

Bacs-Kiskun Varmegyei Oktatokorhaz, Onkoradiologiai Kozpont

Kecskemét, 6000

Hungary

Soroka Medical Center

Beersheba, 84001

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Meir Medical Center

Kfar Saba, 44281

Israel

Galilee Medical Center

Naharyia, 11111

Israel

Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

Aviano, 33081

Italy

IRCCS Candiolo - Istituto di Ricerca

Candiolo, 10060

Italy

Ospedale San Luca - Lucca

Lucca, 55100

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

ASST - Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples

Naples, 80131

Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, 80131

Italy

Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

Pesaro, 61122

Italy

Casa di cura Pederzoli

Peschiera del Garda, 37019

Italy

Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri

Roma, 144

Italy

Universita Cattolica del Sacro Cuore

Roma, 168

Italy

Asst Ovest Milanese - Ospedale Nuovo Di Legnano

Treviglio, 24047

Italy

Nagoya University Hospital

Aichi, 466-8560

Japan

National Cancer Center Hospital East

Chiba, 277-0882

Japan

Shikoku Cancer Center

Ehime, 791-0245

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Kurume University Hospital

Fukuoka, 830-0011

Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518

Japan

Hyogo Cancer Center

Hyōgo, 673-8558

Japan

Kanagawa Cancer Center

Kanagawa, 241-0815

Japan

Kobe City Medical Center General Hospital

Kobe, 650-0047

Japan

Sendai Kousei Hospital

Miyagi, 981-0914

Japan

Niigata University Medical & Dental Hospital

Nigata-shi, 9518520

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Osaka City General Hospital

Osaka, 534-0021

Japan

Kansai Medical University Hospital

Osaka, 573-1191

Japan

Kindai University Hospital

Osaka, 589-8511

Japan

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, 591-8555

Japan

Saitama Prefectural Cancer Center

Saitama, 362-0806

Japan

Juntendo University School of Medicine Juntendo Clinic

Tokyo, 113-8431

Japan

Nippon Medical School (all Hospitals)

Tokyo, 113-8603

Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Pantai Hospital Kuala Lumpur

Kuala Lumpur, 59100

Malaysia

Beacon Hospital

Kuala Selangor, 46050

Malaysia

Sunway Medical Centre

Kuala Selangor, 47500

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

University Malaya Medical Centre

Lembah Pantai, 59100

Malaysia

Amsterdam UMC, Locatie VUMC

Amsterdam, 1081 HV

Netherlands

Zuyderland Medisch Centrum

Heerlen, 6419 PC

Netherlands

Frisius MC location Leeuwarden

Leeuwarden, 8934 AD

Netherlands

Maastricht University Medical Center

Maastricht, 6229 HX

Netherlands

Sint Antonius Ziekenhuis

Utrecht, 3543 AZ

Netherlands

Haukeland University hospital

Bergen, 5009

Norway

Seksjon for kreftbehandling, Drammen Hospital

Drammen, 3004

Norway

Oslo University Hospital

Oslo, 379

Norway

Uniwersytet Medyczny w Lodzi

Lodz, 90-302

Poland

Poznan University of Medical Sciences

Poznan, 60-693

Poland

Podkarpackie Centrum Onkologii Rzeszow

Rzeszów, 35-055

Poland

Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach

Siedlce, 08-110

Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

Stupsk, 076-200

Poland

Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, 02-781

Poland

Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu

Bucharest, 22328

Romania

Spitalul Clinic Coltea

Bucharest, 30171

Romania

S.C Radiotherapy Center Cluj S.R.L

Cluj-Napoca, 407 280

Romania

S.C Centrul de Oncologie S.F Nectarie SRL

Craiova, 200347

Romania

Institul Regional de Oncologie lasi;

Iași, 700483

Romania

S.C Ovidius Clinical Hospital S.R.L

Ovidiu,

Romania

Spitalul Municipal Ploiesti

Ploieşti, 100337

Romania

S.C Oncomed S.R.L

Timișoara, 300239

Romania

Samsung Changwon Hospital

Changwon-Si,

South Korea

Chonnam National University Hwasun Hospital

Gwangju, 61469

South Korea

Korea University Anam Hospital

Seongbuk-Gu,

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591

South Korea

Yonsei University Severance Hospital

Seoul, 120-752

South Korea

Gyeongsang National University Hospital

Seoul, 52727

South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, 16247

South Korea

Ulsan University Hospital

Ulsan, 44033

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

CEIC - Hospital Clinic i Provincial de Barcelona

Barcelona, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i Pujol

Barcelona, 08916

Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, 8906

Spain

Institut Catala d'Oncologia Girona

Girona, 17007

Spain

Complejo Hospitalario de Jaén

Jaén, 23007

Spain

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, 35016

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007

Spain

Facultad de Medicina. Universidad Complutense de Madrid

Madrid, 28041

Spain

Hospital Quironsalud Malaga

Málaga, 29010

Spain

Hospital Universitario Virgen de Valme Sevilla

Seville, 41013

Spain

Hospital Universitario Virgen de Valme

Seville, 41014

Spain

Hospital Clínico Universitario de Valencia

Valencia, 46010

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Changhua Christian Hospital

Changhua, 500-06

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

Taipei Veterans General Hospital

Taipei, 10002

Taiwan

National Taiwan University Cancer Center

Taipei, 100

Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan City, 33305

Taiwan

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom