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Study of Sacituzumab Govitecan for Extensive Stage Small Cell Lung Cancer

This study is looking at sacituzumab govitecan (Trodelvy®) compared to standard treatments like Topotecan, Amrubicin, or Lurbinectedin for people with extensive stage small cell lung cancer (ES-SCLC) that has been treated before. The main goal is to see if sacituzumab govitecan helps people live longer (overall survival). You might be able to join if you are 18 or older, have a confirmed diagnosis of SCLC, and your disease can be measured by scans. The study is currently unclear about its recruitment status and plans to include about 695 participants.

Study design
This is an interventional study comparing sacituzumab govitecan to standard treatments. It plans to enroll 695 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival for up to 4.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06801834

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Gilead Sciences
~695 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Sacituzumab Govitecan (SG)TopotecanAmrubicin (Japan only)Lurbinectedin (regions/countries where approved and available)

At a glance

Recruiting sites
203 of 220 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to 4.5 years

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

220 sites across 40 states
China32
Japan20
Spain16
Brazil12
France12
Italy12
South Korea12
Germany10

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Cente
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Overall Survival (OS)Up to 4.5 years

    OS is defined as length of time from randomization until the date of death from any cause.