Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 3EVOKE-SCLC-04NCT06801834
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
A Phase 3 study testing Sacituzumab Govitecan (SG), Topotecan and Amrubicin (Japan only) in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Gilead Sciences at 219 sites in 23 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- Sacituzumab Govitecan (SG), Topotecan and Amrubicin (Japan only)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 219 sitesin 23 countries
- Study dates
- 4 Apr 2025to Oct 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
219 sites in 23 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Cente contact
219 sites in 23 countries
China32 sites, 32 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
- Recruiting
Jilin Cancer Hospital
Changchun, 130012
- Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
- Recruiting
Chongqing University Cancer Hospital
Chongqing, 404100
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 130012
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310000
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310016
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 552440
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
- Recruiting
The Second Affiliated Hospital of Nanchang University
Jiangxi, 330008
- Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, 250021
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, 650000
- Recruiting
Linyi Cancer Hospital
Linyi, 276000
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330019
- Recruiting
Jiangsu Cancer Hospital
Nanjing, 210009
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
- Recruiting
Shanghai East Hospital
Shanghai, 200123
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
- Recruiting
Shanxi Provincial Cancer Hospital
Shanxi, 030013
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300181
- Recruiting
Weifang No.2 People's Hospital
Weifang, 261041
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430030
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, 361003
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, 453100
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, 225001
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, 450008
United States20 sites, 20 recruiting
- Recruiting
Hendrick Health System
Abilene, Texas, 79601
- Recruiting
New Mexico Oncology Hematology Consultants, Ltd
Albuquerque, New Mexico, 87109
- Recruiting
Los Angeles Cancer Network
Anaheim, California, 92801
- Recruiting
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
- Recruiting
Northwest Cancer Centers
Dyer, Kentucky, 46311
- Recruiting
Spoknwrd Clinical Trials Inc.
Easton, Pennsylvania, 18045
- Recruiting
Parkview Research Center
Fort Wayne, Indiana, 46845
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
- Recruiting
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Boca Raton Regional
Miami, Florida, 33143
- Recruiting
St. Claire Regional Medical Ce
Morehead, Kentucky, 40351
- Recruiting
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
Muncie, Indiana, 47303
- Recruiting
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
- Recruiting
University Hospitals Seidman Cancer Center
Sandusky, Ohio, 44870
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
- Recruiting
Taylor Cancer Research Foundation
Toledo, Ohio, 43617
- Recruiting
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
- Recruiting
Gundersen Health System
West Salem, Wisconsin, 54601
Japan20 sites, 20 recruiting
- Recruiting
Nagoya University Hospital
Aichi, 466-8560
- Recruiting
National Cancer Center Hospital East
Chiba, 277-0882
- Recruiting
Shikoku Cancer Center
Ehime, 791-0245
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
Kurume University Hospital
Fukuoka, 830-0011
- Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
- Recruiting
Hyogo Cancer Center
Hyōgo, 673-8558
- Recruiting
Kanagawa Cancer Center
Kanagawa, 241-0815
- Recruiting
Kobe City Medical Center General Hospital
Kobe, 650-0047
- Recruiting
Sendai Kousei Hospital
Miyagi, 981-0914
- Recruiting
Niigata University Medical & Dental Hospital
Nigata-shi, 9518520
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka City General Hospital
Osaka, 534-0021
- Recruiting
Kansai Medical University Hospital
Osaka, 573-1191
- Recruiting
Kindai University Hospital
Osaka, 589-8511
- Recruiting
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka, 591-8555
- Recruiting
Saitama Prefectural Cancer Center
Saitama, 362-0806
- Recruiting
Juntendo University School of Medicine Juntendo Clinic
Tokyo, 113-8431
- Recruiting
Nippon Medical School (all Hospitals)
Tokyo, 113-8603
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Spain18 sites, 18 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
CEIC - Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
- Recruiting
ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i Pujol
Barcelona, 08916
- Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 8906
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Institut Catala d'Oncologia Girona
Girona, 17007
- Recruiting
Complejo Hospitalario de Jaén
Jaén, 23007
- Recruiting
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, 35016
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Facultad de Medicina. Universidad Complutense de Madrid
Madrid, 28041
- Recruiting
Hospital Quironsalud Malaga
Málaga, 29010
- Recruiting
Hospital Universitario Virgen de Valme Sevilla
Seville, 41013
- Recruiting
Hospital Universitario Virgen de Valme
Seville, 41014
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Brazil12 sites, 12 recruiting
- Recruiting
Instituto do Cancer do Ceara
Fortaleza Ceara, 60430-230
- Recruiting
Hospital de Caridade de Ijui
Ijuí, 98700-000
- Recruiting
Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa Clinica
Natal, 59062-000
- Recruiting
Hospital Mae de Deus
Porto Alegre, 90110-270
- Recruiting
Hospital Sao Lucas da PUC Rio Grande do Sul
Porto Alegre, 90610-000
- Recruiting
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife Pernambuco, 50070-550
- Recruiting
Grupo Oncoclínicas
Santa Lúcia, 30360-680
- Recruiting
Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-650
- Recruiting
Instituto Hemomed Oncologia e Hematologia
São Paulo, 01227-200
- Recruiting
Fundação Pio XII - Hospital de Amor
São Paulo, 14784400
- Recruiting
HB Onco
São Paulo, 15090-000
- Recruiting
Hospital Amaral Carvalho
São Paulo, 17210-080
France12 sites, 12 recruiting
- Recruiting
CHU Angers - Hôpital Larrey
Angers, 49933
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
- Recruiting
CHU Grenoble Alpes - Hopital Albert Michallon
La Tronche, 38700
- Recruiting
Hôpital Lyon Sud - Hospices Civils de Lyon
Lyon, 69003
- Recruiting
Assistance Publique - Hopitaux de Marseille, Hopital Nord
Marseille, 13005
- Recruiting
Hopital Tenon - Assistance Publique Hopitaux de Paris
Paris, 75020
- Recruiting
Institut Curie
Paris, 75248
- Recruiting
Hopital Haut-Leveque
Pessac, 33604
- Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes, 35033
- Recruiting
Centre Hospitalier Universitaire de Nantes
Saint-Herblain, 44805
- Recruiting
Hopital Saint Joseph - Paris
Saint-Mandé, 94160
- Recruiting
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
Italy12 sites, 11 recruiting
- Recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
Aviano, 33081
- Recruiting
IRCCS Candiolo - Istituto di Ricerca
Candiolo, 10060
- Recruiting
Ospedale San Luca - Lucca
Lucca, 55100
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
- Recruiting
ASST - Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples
Naples, 80131
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
- Recruiting
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
Pesaro, 61122
- Recruiting
Casa di cura Pederzoli
Peschiera del Garda, 37019
- Recruiting
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
Roma, 144
- Recruiting
Universita Cattolica del Sacro Cuore
Roma, 168
- Active, not recruiting
Asst Ovest Milanese - Ospedale Nuovo Di Legnano
Treviglio, 24047
South Korea12 sites, 12 recruiting
- Recruiting
Samsung Changwon Hospital
Changwon-Si
- Recruiting
Chonnam National University Hwasun Hospital
Gwangju, 61469
- Recruiting
Korea University Anam Hospital
Seongbuk-Gu
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
- Recruiting
Yonsei University Severance Hospital
Seoul, 120-752
- Recruiting
Gyeongsang National University Hospital
Seoul, 52727
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Germany10 sites, 8 recruiting
- Recruiting
Vivantes Klinikum Neukoelln,
Berlin, 12351
- Active, not recruiting
Charité Universitatsmedizin Berlin
Berlin, 13353
- Recruiting
Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische Onkologie
Bochum, 44791
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 9113
- Recruiting
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie and Pneumologie
Esslingen am Neckar, 73730
- Recruiting
UKE Hamburg-Eppendorf fur Onkologie
Hamburg, 20251
- Recruiting
Katholisches Marienkrankenhaus gGmbH
Hamburg, 22087
- Recruiting
Fachklinik Loewenstein
Löwenstein, 74245
- Recruiting
Johannes Wesling Klinikum Minden
Minden, 32429
- Active, not recruiting
LMU-Campus Innenstadt
Munich, 80336
Romania8 sites, 8 recruiting
- Recruiting
Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu
Bucharest, 22328
- Recruiting
Spitalul Clinic Coltea
Bucharest, 30171
- Recruiting
S.C Radiotherapy Center Cluj S.R.L
Cluj-Napoca, 407 280
- Recruiting
S.C Centrul de Oncologie S.F Nectarie SRL
Craiova, 200347
- Recruiting
Institul Regional de Oncologie lasi;
Iași, 700483
- Recruiting
S.C Ovidius Clinical Hospital S.R.L
Ovidiu
- Recruiting
Spitalul Municipal Ploiesti
Ploieşti, 100337
- Recruiting
S.C Oncomed S.R.L
Timișoara, 300239
Taiwan8 sites, 3 recruiting
- Active, not recruiting
Changhua Christian Hospital
Changhua, 500-06
- Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Active, not recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
Taipei Veterans General Hospital
Taipei, 10002
- Recruiting
National Taiwan University Cancer Center
Taipei, 100
- Active, not recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
- Completed
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 33305
Greece7 sites, 7 recruiting
- Recruiting
Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology Department
Athens, 11522
- Recruiting
Henry Dunant Hospital Center, 4th Oncology Clinic
Athens, 11526
- Recruiting
Metropolitan Hospital
Athens, 185 47
- Recruiting
University General Hospital of Larissa Department of Medical Oncology
Larissa, 41110
- Recruiting
University General Hospital of Patras, Division of Oncology
Rio, 26500
- Recruiting
St Luke's Hospital Oncology Department, Panorama
Thessaloniki, 552 36
- Recruiting
Interbalkan Hospital of Thessaloniki
Thessaloniki, 57001
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Britanico de Buenos Aires
Buenos Aires, 1280
- Recruiting
Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires)
Buenos Aires, C1426ANZ
- Recruiting
Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata
Buenos Aires
- Recruiting
Centro Oncologico de Excelencia (San Juan)
San Juan
- Recruiting
Centro Médico San Roque
San Miguel de Tucumán, T4000IAN
- Recruiting
Sanatorio Parque SA
Santa Fe, 2000
Australia6 sites, 6 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
- Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
- Recruiting
Cancer Care Wollongong
New South Wales, New South Wales, 2500
- Recruiting
Metro North HHS (The Prince Charles Hospital)
Queensland, Queensland, 4006
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
Poland6 sites, 6 recruiting
- Recruiting
Uniwersytet Medyczny w Lodzi
Lodz, 90-302
- Recruiting
Poznan University of Medical Sciences
Poznan, 60-693
- Recruiting
Podkarpackie Centrum Onkologii Rzeszow
Rzeszów, 35-055
- Recruiting
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
Siedlce, 08-110
- Recruiting
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
Stupsk, 076-200
- Recruiting
Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Belgium5 sites, 5 recruiting
- Recruiting
Grand Hopital de Charleroi
Charleroi, 6000
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
- Recruiting
Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1
Liège, 4000
- Recruiting
AZ Delta
Roeselare, 8800
- Recruiting
Vitaz
Sint-Niklaas, 9100
Canada5 sites, 5 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, L4M 6M2
- Recruiting
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, L8V 1C3
- Recruiting
McGill University
Montreal, H4A 3J1
- Recruiting
CISSS BSL / Hopital regional de Rimouski
Rimouski, G5L 5T1
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, M4N 3M5
Israel5 sites, 5 recruiting
- Recruiting
Soroka Medical Center
Beersheba, 84001
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
- Recruiting
Meir Medical Center
Kfar Saba, 44281
- Recruiting
Galilee Medical Center
Naharyia, 11111
Malaysia5 sites
- Completed
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 59100
- Completed
Beacon Hospital
Kuala Selangor, 46050
- Completed
Sunway Medical Centre
Kuala Selangor, 47500
- Active, not recruiting
Sarawak General Hospital
Kuching, 93586
- Completed
University Malaya Medical Centre
Lembah Pantai, 59100
Netherlands5 sites, 5 recruiting
- Recruiting
Amsterdam UMC, Locatie VUMC
Amsterdam, 1081 HV
- Recruiting
Zuyderland Medisch Centrum
Heerlen, 6419 PC
- Recruiting
Frisius MC location Leeuwarden
Leeuwarden, 8934 AD
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
- Recruiting
Sint Antonius Ziekenhuis
Utrecht, 3543 AZ
Norway3 sites, 3 recruiting
- Recruiting
Haukeland University hospital
Bergen, 5009
- Recruiting
Seksjon for kreftbehandling, Drammen Hospital
Drammen, 3004
- Recruiting
Oslo University Hospital
Oslo, 379
Hungary1 site, 1 recruiting
- Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz, Onkoradiologiai Kozpont
Kecskemét, 6000
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
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)
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).
- Being tested
- Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only), Lurbinectedin (regions/countries where approved and available)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan (SG)Drug
Also called Trodelvy®, GS-0132, IMMU 132
Administered intravenously
TopotecanDrug
Administered intravenously
Amrubicin (Japan only)Drug
Administered intravenously
Lurbinectedin (regions/countries where approved and available)Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A: SG | Experimental | 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. Receives: Drug: Sacituzumab Govitecan (SG) |
| Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin | Experimental | Participants 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. Receives: Drug: Topotecan; Drug: Amrubicin (Japan only); Drug: Lurbinectedin (regions/countries where approved and available) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as length of time from randomization until the date of death from any cause.
Measured: Up to 4.5 years
Secondary outcomes (7)
Progression-free Survival (PFS)
PFS is defined as the time from date of randomization until disease progression as assessed by investigator according to RECIST v1.1 or death from any cause, whichever comes first.
Measured: Up to 4.5 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have achieved a CR or PR as assessed by investigator according to RECIST v1.1.
Measured: Up to 4.5 years
Duration of Response (DOR)
DOR is defined as is measured from the time of first response (CR or PR) as assessed by investigator according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first
Measured: Up to 4.5 years
Time to First Deterioration in Shortness of Breath Domain
Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.
Measured: Up to 4.5 years
Time to First Deterioration in Physical Functioning Domain
Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.
Measured: Up to 4.5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAE is defined as any AEs occurred during the treatment-emergent period. The treatment-emergent period is defined as the time period from the first dose of study treatment to the earlier of 30 days following the last dose of study treatment or the initiation of subsequent anticancer therapy.
Measured: First dose date up to 4.5 years
Percentage of Participants Experiencing Clinical Laboratory abnormalities
Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.
Measured: First dose date up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start4 Apr 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 695 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801834
- Sponsor's protocol ID
- GS-US-600-6165
- Other IDs
- 2024-515884-69
- Acronym
- EVOKE-SCLC-04
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No