At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sacituzumab Govitecan (SG) (drug), Topotecan (drug), Amrubicin (Japan only) (drug), Lurbinectedin (regions/countries where approved and available) (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Sacituzumab Govitecan (SG) — drug: Administered intravenously · Topotecan — drug: Administered intravenously · Amrubicin (Japan only) — drug: Administered intravenously · Lurbinectedin (regions/countries where approved and available) — drug: Administered intravenously
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at sacituzumab govitecan compared with standard care for people with extensive stage small cell lung cancer (ES-SCLC) that has already been treated. Small cell lung cancer is a type of lung cancer; 'extensive stage' means it has spread beyond the lung. It is run by Gilead Sciences.
Who can take part
- A confirmed diagnosis of small cell lung cancer based on tissue testing.
- Fairly fit and active, shown by a performance status score of 0 or 1 (a scale doctors use to measure how well someone can carry out daily activities).
- Cancer that can be measured on a CT (computed tomography) or MRI (magnetic resonance imaging) scan.
- Cancer that got worse after one previous course of platinum-based chemotherapy (at least 2 cycles), with or without treatment called PD-1 or PD-L1 therapy.
- If platinum chemotherapy was given for earlier limited stage disease and the cancer came back 30 to 180 days after the last dose, this counts as the one previous course.
- People who have had, or may have, a treatment called tarlatamab can still take part.
- At least 85% of people in the study must have had previous PD-1 or PD-L1 therapy.
Who may not be able to
- Cancer came back less than 30 days after the last dose of first-line platinum chemotherapy.
- Previous treatment with certain drugs including irinotecan, topotecan, sacituzumab govitecan, SN-38, exatecan derivatives or similar drugs targeting topoisomerase I (a protein involved in cancer cell growth), or lurbinectedin after platinum chemotherapy.
- Cancer spread to the tissues lining the brain and spinal cord (meningitis), with some exceptions: treated brain metastases that have been stable for at least 4 weeks, with no new symptoms and on no more than 10 mg a day of prednisone or similar, may be allowed; small untreated brain metastases (5 mm or less, 3 or fewer, with no swelling and no symptoms) may also be allowed.
- People whose doctors think platinum chemotherapy again (rechallenge) would help cannot take part.
What taking part involves
- • Being given either sacituzumab govitecan or standard of care treatment (the usual treatment for this cancer), decided by chance (randomised) — Not stated — ask the trial team
- • Scans (CT or MRI) to measure the cancer — Not stated — ask the trial team about how often
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 695
- Started
- 2025-04-04
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for extensive stage small cell lung cancer (es-sclc)
- • Phase3 - 695 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with extensive stage small cell lung cancer (es-sclc)
Where?
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with
What the study is looking for
- ✓confirmed by a biopsy diagnosis of SCLC.
- ✓activity scale (ECOG) performance status score of 0 or 1.
- ✓cancer that can be measured on scans by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per...
- ✓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
- ✗Note: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Where Is This Study? (1 UK site)
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Gilead Clinical Study Information Cente
Sponsor contactCONTACT
