Study Details

OVERVIEW

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) (EVOKE-SCLC-04)

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Gender

N/A

Date

April 2025 - October 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only)

Eligibility Information

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.

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.

Locations

Locations (196)

Los Angeles Cancer Network

Anaheim, California, United States, 92801

Hope and Healing Cancer Services

Hinsdale, Illinois, United States, 60521

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Springfield Clinic

Springfield, Illinois, United States, 62702

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

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

Muncie, Indiana, United States, 47303

Northwest Cancer Centers

Dyer, Kentucky, United States, 46311

St. Claire Regional Medical Ce

Morehead, Kentucky, United States, 40351

New Mexico Oncology Hematology Consultants, Ltd

Albuquerque, New Mexico, United States, 87109

University Hospitals Seidman Cancer Center

Sandusky, Ohio, United States, 44870

Taylor Cancer Research Foundation

Toledo, Ohio, United States, 43617

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, United States, 18045

Hendrick Health System

Abilene, Texas, United States, 79601

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Texas Oncology - San Antonio

New Braunfels, Texas, United States, 78130

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States, 75708

Gundersen Health System

West Salem, Wisconsin, United States, 54601

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina, 1280

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

Buenos Aires, Argentina, C1426ANZ

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, T4000IAN

Sanatorio Parque SA

Santa Fe, Argentina, 2000

Cancer Care Wollongong

New South Wales, New South Wales, Australia, 2500

Metro North HHS (The Prince Charles Hospital)

Queensland, Queensland, Australia, 4006

Gold Coast University Hospital

Southport, Queensland, Australia, 4215

Cancer Research SA

Adelaide, South Australia, Australia, 5000

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Grand Hopital de Charleroi

Charleroi, Belgium, 6000

Jessa Ziekenhuis

Hasselt, Belgium, 3500

AZ Delta

Roeselare, Belgium, 8800

Vitaz

Sint-Niklaas, Belgium, 9100

Instituto do Cancer do Ceara

Fortaleza Ceara, Brazil, 60430-230

Hospital de Caridade de Ijui

Ijuí, Brazil, 98700-000

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

Natal, Brazil, 59062-000

Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Hospital Sao Lucas da PUC Rio Grande do Sul

Porto Alegre, Brazil, 90610-000

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Recife Pernambuco, Brazil, 50070-550

Grupo Oncoclínicas

Santa Lúcia, Brazil, 30360-680

Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil, 09060-650

Instituto Hemomed Oncologia e Hematologia

São Paulo, Brazil, 01227-200

Fundação Pio XII - Hospital de Amor

São Paulo, Brazil, 14784400

HB Onco

São Paulo, Brazil, 15090-000

Hospital Amaral Carvalho

São Paulo, Brazil, 17210-080

Royal Victoria Regional Health Centre

Barrie, Canada, L4M 6M2

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Canada, L8V 1C3

McGill University

Montreal, Canada, H4A 3J1

CISSS BSL / Hopital regional de Rimouski

Rimouski, Canada, G5L 5T1

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Beijing Cancer Hospital

Beijing, China, 100142

Jilin Cancer Hospital

Changchun, China, 130012

Sichuan Cancer Hospital

Chengdu, China, 610041

Chongqing University Cancer Hospital

Chongqing, China, 404100

Fujian Medical University Union Hospital

Fuzhou, China, 350001

Sun Yat-sen University Cancer Center

Guangzhou, China, 130012

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China, 510080

Zhejiang Cancer Hospital

Hangzhou, China, 310000

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China, 310009

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China, 310016

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China, 552440

Harbin Medical University Cancer Hospital

Harbin, China, 150081

The Second Affiliated Hospital of Nanchang University

Jiangxi, China, 330008

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China, 250021

The Second Affiliated Hospital of Kunming Medical University

Kunming, China, 650000

Linyi Cancer Hospital

Linyi, China, 276000

The First Affiliated Hospital of Nanchang University

Nanchang, China, 330019

Jiangsu Cancer Hospital

Nanjing, China, 210009

Shanghai Chest Hospital

Shanghai, China, 200030

Fudan University Shanghai Cancer Center

Shanghai, China

Shanxi Provincial Cancer Hospital

Shanxi, China, 030013

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China, 300181

Weifang No.2 People's Hospital

Weifang, China, 261041

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

Wuhan, China, 430030

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

Wuhan, China, 430030

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

The First Affiliated Hospital of Xiamen University

Xiamen, China, 361003

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China, 453100

Northern Jiangsu People's Hospital

Yangzhou, China, 225001

Henan Provincial Cancer Hospital

Zhengzhou, China, 450008

CHU Angers - Hôpital Larrey

Angers, France, 49933

Centre Hospitalier Intercommunal de Créteil

Créteil, France, 94000

CHU Grenoble Alpes - Hopital Albert Michallon

La Tronche, France, 38700

Hôpital Lyon Sud - Hospices Civils de Lyon

Lyon, France, 69003

Assistance Publique - Hopitaux de Marseille, Hopital Nord

Marseille, France, 13005

Hopital Tenon - Assistance Publique Hopitaux de Paris

Paris, France, 75020

Institut Curie

Paris, France, 75248

Hopital Haut-Leveque

Pessac, France, 33604

CHU Rennes - Hopital Pontchaillou

Rennes, France, 35033

Centre Hospitalier Universitaire de Nantes

Saint-Herblain, France, 44805

Hopital Saint Joseph - Paris

Saint-Mandé, France, 94160

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 9113

Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and Pneumologie

Esslingen am Neckar, Germany, 73730

UKE Hamburg-Eppendorf fur Onkologie

Hamburg, Germany, 20251

Katholisches Marienkrankenhaus gGmbH

Hamburg, Germany, 22087

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

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

Athens, Greece, 11522

Henry Dunant Hospital Center, 4th Oncology Clinic

Athens, Greece, 11526

Metropolitan Hospital

Athens, Greece, 185 47

University General Hospital of Larissa Department of Medical Oncology

Larissa, Greece, 41110

University General Hospital of Patras, Division of Oncology

Rio, Greece, 26500

St Luke's Hospital Oncology Department, Panorama

Thessaloniki, Greece, 552 36

Interbalkan Hospital of Thessaloniki

Thessaloniki, Greece, 57001

Soroka Medical Center

Beersheba, Israel, 84001

Rambam Health Care Campus

Haifa, Israel, 3109601

Hadassah Medical Center

Jerusalem, Israel, 9112001

Meir Medical Center

Kfar Saba, Israel, 44281

Galilee Medical Center

Naharyia, Israel, 11111

Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

Aviano, Italy, 33081

IRCCS Candiolo - Istituto di Ricerca

Candiolo, Italy, 10060

Ospedale San Luca - Lucca

Lucca, Italy, 55100

ASST - Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples

Naples, Italy, 80131

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy, 80131

Casa di cura Pederzoli

Peschiera del Garda, Italy, 37019

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

Roma, Italy, 144

Universita Cattolica del Sacro Cuore

Roma, Italy, 168

Nagoya University Hospital

Aichi, Japan, 466-8560

Shikoku Cancer Center

Ehime, Japan, 791-0245

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Kurume University Hospital

Fukuoka, Japan, 830-0011

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan, 730-8518

Hyogo Cancer Center

Hyōgo, Japan, 673-8558

Kanagawa Cancer Center

Kanagawa, Japan, 241-0815

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Sendai Kousei Hospital

Miyagi, Japan, 981-0914

Niigata University Medical & Dental Hospital

Nigata-shi, Japan, 9518520

Okayama University Hospital

Okayama, Japan, 700-8558

Osaka City General Hospital

Osaka, Japan, 534-0021

Kansai Medical University Hospital

Osaka, Japan, 573-1191

Kindai University Hospital

Osaka, Japan, 589-8511

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan, 591-8555

Saitama Prefectural Cancer Center

Saitama, Japan, 362-0806

Juntendo University School of Medicine Juntendo Clinic

Tokyo, Japan, 113-8431

Nippon Medical School (all Hospitals)

Tokyo, Japan, 113-8603

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 59100

Beacon Hospital

Kuala Selangor, Malaysia, 46050

Sunway Medical Centre

Kuala Selangor, Malaysia, 47500

Sarawak General Hospital

Kuching, Malaysia, 93586

University Malaya Medical Centre

Lembah Pantai, Malaysia, 59100

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands, 1081 HV

Zuyderland Medisch Centrum

Heerlen, Netherlands, 6419 PC

Frisius MC location Leeuwarden

Leeuwarden, Netherlands, 8934 AD

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

Sint Antonius Ziekenhuis

Utrecht, Netherlands, 3543 AZ

Haukeland University hospital

Bergen, Norway, 5009

Oslo University Hospital

Oslo, Norway, 379

Uniwersytet Medyczny w Lodzi

Lodz, Poland, 90-302

Poznan University of Medical Sciences

Poznan, Poland, 60-693

Podkarpackie Centrum Onkologii Rzeszow

Rzeszów, Poland, 35-055

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

Siedlce, Poland, 08-110

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

Stupsk, Poland, 076-200

Spitalul Clinic Coltea

Bucharest, Romania, 30171

S.C Radiotherapy Center Cluj S.R.L

Cluj-Napoca, Romania, 407 280

S.C Centrul de Oncologie S.F Nectarie SRL

Craiova, Romania, 200347

S.C Ovidius Clinical Hospital S.R.L

Ovidiu, Romania

Spitalul Municipal Ploiesti

Ploieşti, Romania, 100337

S.C Oncomed S.R.L

Timișoara, Romania, 300239

Samsung Changwon Hospital

Changwon-Si, South Korea

Chonnam National University Hwasun Hospital

Gwangju, South Korea, 61469

Korea University Anam Hospital

Seongbuk-Gu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Kangbuk Samsung Hospital

Seoul, South Korea, 03181

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 06351

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

Seoul, South Korea, 06591

Yonsei University Severance Hospital

Seoul, South Korea, 120-752

Gyeongsang National University Hospital

Seoul, South Korea, 52727

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

Suwon, South Korea, 16247

Ulsan University Hospital

Ulsan, South Korea, 44033

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

CEIC - Hospital Clinic i Provincial de Barcelona

Barcelona, Spain, 08036

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041

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

Barcelona, Spain, 08916

Institut Catala d'Oncologia Girona

Girona, Spain, 17007

Complejo Hospitalario de Jaén

Jaén, Spain, 23007

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, Spain, 35016

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Facultad de Medicina. Universidad Complutense de Madrid

Madrid, Spain, 28041

Hospital Quironsalud Malaga

Málaga, Spain, 29010

Hospital Universitario Virgen de Valme Sevilla

Seville, Spain, 41013

Hospital Universitario Virgen de Valme

Seville, Spain, 41014

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Changhua Christian Hospital

Changhua, Taiwan, 500-06

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

National Taiwan University Cancer Center

Taipei, Taiwan, 100

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 112

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan, 33305

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)