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Taking people in TaiwanPhase 3

Tests sacituzumab govitecan against standard treatment in small cell lung cancer

Compares sacituzumab govitecan with standard care in adults with previously treated lung cancer.

Key facts

Who runs it
Gilead Sciences
Where
Changhua, Kaohsiung City, Taichung, Tainan, Taipei, and Taoyuan City, TaiwanSee the 8 sitesAlso in 22 other countries, 211 sites
Registry title
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
People taking part
695 people, planned
Started
4 Apr 2025
Expected to end
Oct 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Sacituzumab Govitecan (SG)
  • Topotecan
  • Amrubicin (Japan only)
  • Lurbinectedin (regions/countries where approved and available)
Record updated
20 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Check if you might fit

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?

Where in Taiwan

Also in 22 other countries, 211 sites

  • Changhua Christian HospitalChanghua, TaiwanNo longer taking part
  • Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanNo longer taking part
  • Taichung Veterans General HospitalTaichung, TaiwanNo longer taking part
  • National Cheng Kung University HospitalTainan, TaiwanTaking people
  • National Taiwan University Cancer CenterTaipei, TaiwanTaking people
  • Taipei Veterans General HospitalTaipei, TaiwanTaking people
  • Koo Foundation Sun Yat-Sen Cancer CenterTaipei, TaiwanNo longer taking part
  • Chang Gung Memorial Hospital LinkouTaoyuan City, TaiwanNo longer taking part

About the trial

What the trial wants to find out

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

The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).

The 2 groups in the trial

  • Treatment Group A: SGTreatment being tested

    Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

    Treatment: Sacituzumab Govitecan (SG)

  • Treatment Group B: Topotecan, or Lurbinectedin, or AmrubicinTreatment being tested

    Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle: * Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or * Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available). In Japan, participants assigned to Treatment Group B may alternatively receive: • Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle. Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.

    Treatment: Topotecan, Amrubicin (Japan only), and Lurbinectedin (regions/countries where approved and available)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Tests sacituzumab govitecan against standard treatment in small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06801834, who can take part
Record updated
20 October 2026