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Clinical Trials in Germany / NCT06801834
Recruiting Phase 3

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

NCT06801834 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-04-04
Last updated
2026-08-12

Condition(s) studied

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan (SG) →Topotecan →Amrubicin (Japan only) →Lurbinectedin (regions/countries where approved and available) →

Sacituzumab Govitecan (SG): Administered intravenously

Topotecan: Administered intravenously

Amrubicin (Japan only): Administered intravenously

Lurbinectedin (regions/countries where approved and available): Administered intravenously

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (220)

FacilityCityRegionStatus
Alaska Oncology and Hematology Anchorage Alaska Recruiting
Genesis Cancer and Blood Institute Hot Springs Arkansas Recruiting
Los Angeles Cancer Network Anaheim California Recruiting
Boca Raton Regional Miami Florida Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
Southern Illinois University School of Medicine Springfield Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Parkview Research Center Fort Wayne Indiana Recruiting
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie Muncie Indiana Recruiting
Northwest Cancer Centers Dyer Kentucky Recruiting
St. Claire Regional Medical Ce Morehead Kentucky Recruiting
Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky Not Yet Recruiting
MaineHealth Cancer Care Scarborough Maine Not Yet Recruiting
OptumCare Cancer Care Las Vegas Nevada Not Yet Recruiting
New Mexico Oncology Hematology Consultants, Ltd Albuquerque New Mexico Recruiting
University Hospitals Seidman Cancer Center Sandusky Ohio Recruiting
Taylor Cancer Research Foundation Toledo Ohio Recruiting
Spoknwrd Clinical Trials Inc. Easton Pennsylvania Recruiting
Hendrick Health System Abilene Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - San Antonio New Braunfels Texas Recruiting
The University of Texas Health Science Center at Tyler Tyler Texas Recruiting
Gundersen Health System West Salem Wisconsin Recruiting
Hospital Britanico de Buenos Aires Buenos Aires Argentina Recruiting
Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires) Buenos Aires Argentina Recruiting
Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata Buenos Aires Argentina Recruiting
Centro Oncologico de Excelencia (San Juan) San Juan Argentina Recruiting
Centro Médico San Roque San Miguel de Tucumán Argentina Recruiting
Sanatorio Parque SA Santa Fe Argentina Recruiting
Cancer Care Wollongong New South Wales New South Wales Recruiting
Metro North HHS (The Prince Charles Hospital) Queensland Queensland Recruiting
Gold Coast University Hospital Southport Queensland Recruiting
Cancer Research SA Adelaide South Australia Recruiting
St Vincent's Hospital Melbourne Fitzroy Victoria Recruiting
Sir Charles Gairdner Hospital Nedlands Western Australia Recruiting
Grand Hopital de Charleroi Charleroi Belgium Recruiting
Jessa Ziekenhuis Hasselt Belgium Recruiting
Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1 Liège Belgium Recruiting
AZ Delta Roeselare Belgium Recruiting
Vitaz Sint-Niklaas Belgium Recruiting

+ 180 more sites — see the full list on the official registry below.

More Gilead Sciences trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801834 on ClinicalTrials.gov ↗ ← All trials in Germany