Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
EVOKE-SCLC-04
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)
2 other identifiers
interventional
695
23 countries
205
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Typical duration for phase_3
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2025
CompletedStudy Start
First participant enrolled
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
April 29, 2026
April 1, 2026
4.5 years
January 24, 2025
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as length of time from randomization until the date of death from any cause.
Up to 4.5 years
Secondary Outcomes (7)
Progression-free Survival (PFS)
Up to 4.5 years
Objective Response Rate (ORR)
Up to 4.5 years
Duration of Response (DOR)
Up to 4.5 years
Time to First Deterioration in Shortness of Breath Domain
Up to 4.5 years
Time to First Deterioration in Physical Functioning Domain
Up to 4.5 years
- +2 more secondary outcomes
Study Arms (2)
Treatment Group A: SG
EXPERIMENTALParticipants 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.
Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
EXPERIMENTALParticipants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle: * Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or * Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available). In Japan, participants assigned to Treatment Group B may alternatively receive: • Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle. Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.
Interventions
Administered intravenously
Administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (205)
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
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
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
Johannes Wesling Klinikum Minden
Minden, 32429, 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
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
Nagoya University Hospital
Aichi, 466-8560, 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
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
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, 33305, Taiwan
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Central Study Contacts
Gilead Clinical Study Information Cente
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2025
First Posted
January 30, 2025
Study Start
April 4, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share