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
- Barrie, Hamilton, Montreal, Rimouski, and Toronto, CanadaSee the 5 sites
- Phase
- Phase 3
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 Canada
- Royal Victoria Regional Health CentreBarrie, CanadaTaking people
- Hamilton Health Sciences-Juravinski Cancer CentreHamilton, CanadaTaking people
- McGill UniversityMontreal, CanadaTaking people
- CISSS BSL / Hopital regional de RimouskiRimouski, CanadaTaking people
- Sunnybrook Health Sciences CentreToronto, CanadaTaking 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).