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Looking for participantsPhase3

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

Sponsor: Gilead Sciences

NCT ID: NCT06801834

View on ClinicalTrials.gov ↗

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).

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

PD-L1

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
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where Is This Study? (1 UK site)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Gilead Clinical Study Information Cente

Sponsor contact

CONTACT

1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08