Sacituzumab Govitecan for Extensive Stage Small Cell Lung Cancer

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

Recruiting Phase 3 Interventional Study
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
695 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for

This trial is looking for patients with extensive stage small cell lung cancer that has been treated before. Participants will receive the study drug sacituzumab govitecan to see how it works compared to standard treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with extensive stage small cell lung cancer.
  • I have an ECOG performance status score of 0 or 1.
  • My cancer can be measured by a CT or MRI scan.
  • I have had disease progression after at least 1 treatment with platinum-based chemotherapy.
  • I was treated with a platinum-based therapy for earlier stage small cell lung cancer and my cancer progressed within the last 30 to 180 days.
  • I have not been treated with certain cancer medications before.
  • I can participate if I have stable brain metastases with no new symptoms.

You may not be able to join if

  • I have had disease progression less than 30 days after my last platinum treatment.
  • I have received certain types of cancer treatment like irinotecan or topotecan before.
  • I have carcinomatous meningitis or certain types of central nervous system metastasis.
  • I am currently taking more than 10 mg of prednisone or equivalent.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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).

Trial Locations
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Eligibility 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. * Document…
Contacts

Gilead Clinical Study Information Cente

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

CONTACT