Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
Recruiting · NCT06801834 · Interventional (participants receive a specific treatment) · Lead sponsor: Gilead Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Amrubicin (Japan only)Lurbinectedin (regions/countries where approved and available)Sacituzumab Govitecan (SG)Topotecan
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 14 US states.
- 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
- Owensboro Health Mitchell Memorial Cancer Center - Owensboro, Kentucky, United States
- MaineHealth Cancer Care - Scarborough, Maine, United States
- OptumCare Cancer Care - Las Vegas, Nevada, 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
- Complejo Hospitalario Universitario A Coruña - A Coruña, Spain
- Nagoya University Hospital - Aichi, Japan
- Amsterdam UMC, Locatie VUMC - Amsterdam, Netherlands
- CHU Angers - Hôpital Larrey - Angers, France
- Anticancer-Oncology Hospital of Athens 'Agios Sawas' 1st Pathology-Oncology Department - Athens, Greece
- Henry Dunant Hospital Center, 4th Oncology Clinic - Athens, Greece
- Metropolitan Hospital - Athens, Greece
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano - Aviano, Italy
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- CEIC - Hospital Clinic i Provincial de Barcelona - Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- ICO(Instituto Catalan de Oncologia) Badalona - Germans Trias i Pujol - Barcelona, Spain
- ICO l'Hospitalet - Hospital Duran i Reynals - Barcelona, Spain
- Royal Victoria Regional Health Centre - Barrie, Canada
- Soroka Medical Center - Beersheba, Israel
- Beijing Cancer Hospital - Beijing, China
- Haukeland University hospital - Bergen, Norway
- Vivantes Klinikum Neukoelln, - Berlin, Germany
- Charité Universitatsmedizin Berlin - Berlin, Germany
- Augusta-Kranken-Anstalt gGmbH, Klinik f. Haematologie u. internistische Onkologie - Bochum, Germany
- Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu - Bucharest, Romania
- Spitalul Clinic Coltea - Bucharest, Romania
- 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
- IRCCS Candiolo - Istituto di Ricerca - Candiolo, Italy
- Jilin Cancer Hospital - Changchun, China
- Changhua Christian Hospital - Changhua, Taiwan
- Samsung Changwon Hospital - Changwon-Si, South Korea
- Grand Hopital de Charleroi - Charleroi, Belgium
- Klinikum Chemnitz gGmbH - Chemnitz, Germany
- Sichuan Cancer Hospital - Chengdu, China
- National Cancer Center Hospital East - Chiba, Japan
- Chongqing University Cancer Hospital - Chongqing, China
- S.C Radiotherapy Center Cluj S.R.L - Cluj-Napoca, Romania
- S.C Centrul de Oncologie S.F Nectarie SRL - Craiova, Romania
- Centre Hospitalier Intercommunal de Créteil - Créteil, France
Showing 60 of 220 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →