NCT06801834 · Gilead Sciences
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
(EVOKE-SCLC-04)
What this study 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 the usual treatment (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).
View original scientific description
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).
Interventions
DRUG
Sacituzumab Govitecan (SG)
Administered intravenously
DRUG
Topotecan
Administered intravenously
DRUG
Amrubicin (Japan only)
Administered intravenously
DRUG
Lurbinectedin (regions/countries where approved and available)
Administered intravenously
Primary outcome measures
Overall Survival (OS)
Time frame: Up to 4.5 years
OS is defined as length of time from randomization until the date of death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. 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.
Where
- Hot Springs, Arkansas
- Anaheim, California
- Miami, Florida
- Hinsdale, Illinois
- Springfield, Illinois
- Fort Wayne, Indiana
- Muncie, Indiana
- Dyer, Kentucky
- Morehead, Kentucky
- Scarborough, Maine
- Las Vegas, Nevada
- Albuquerque, New Mexico
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations