Tests sacituzumab govitecan against standard treatment in small cell lung cancer
Compares sacituzumab govitecan with standard care in adults with previously treated lung cancer.
Plain-language title generated from the registry record
Registry title: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
Key facts
- Where
- Adelaide, Fitzroy, Nedlands, New South Wales, Queensland, and Southport, AustraliaSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive stage small cell lung cancer that got worse after one earlier round of platinum chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer confirmed under the microscope, extensive stage, with disease that can be measured on a CT or MRI scan and has progressed on scans.
- Earlier treatment
- Must have had 1 prior line of platinum-containing chemotherapy (at least 2 cycles), with or without PD-1 or PD-L1 therapy. Cannot have had irinotecan, topotecan, SG, SN-38, exatecan derivatives or similar drugs, or lurbinectedin after platinum chemotherapy.
Main reasons for not taking part
- Less than 30 days between the last dose of first-line platinum chemotherapy and disease progression
- Any earlier treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives or similar drugs
- Lurbinectedin received after progression on or after platinum chemotherapy
- Cancer in the lining of the brain and spinal cord (meningitis) from the cancer
- Brain metastases that are not stable, or untreated ones that cause symptoms, have swelling around them, are larger than 5 mm, or number more than 3
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06801834, who can take part
Where in Australia
- Cancer Research SAAdelaide, AustraliaTaking people
- St Vincent's Hospital MelbourneFitzroy, AustraliaTaking people
- Sir Charles Gairdner HospitalNedlands, AustraliaTaking people
- Cancer Care WollongongNew South Wales, AustraliaTaking people
- Metro North HHS (The Prince Charles Hospital)Queensland, AustraliaTaking people
- Gold Coast University HospitalSouthport, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT06801834
- Record updated
- 20 October 2026
- Original 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).Read full original descriptionShow less
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).
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; 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.
Exclusion: 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; 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).