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Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
NCT03088813 · View on ClinicalTrials.gov ↗
Study Summary
A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG Irinotecan liposome injection
Study Locations (20)
Michigan
- Henry Ford Hospital — Detroit
- Cancer & Hematology Centers of Western Michigan — Grand Rapids
- Sparrow Regional Cancer Center — Lansing
Colorado
- National Jewish Health — Denver
- Rocky Mountain Cancer Centers — Denver
Florida
- Florida Cancer Specialists (South Region) — Fort Myers
- Florida Cancer Specialists — St. Petersburg
Georgia
- Northwest Georgia Oncology Centers — Marietta
- Cancer Treatment Centers of America-Georgia — Newnan
New York
- Roswell Park Cancer Institute — Buffalo
- North Shore Hematology Oncology Associates, PC — East Setauket
Ohio
- Case Western Reserve University — Cleveland
- Tri County Hematology & Oncology Associates, Inc — Massillon
South Carolina
- Charleston Hematology Oncology Associates, PA — Charleston
- Greenville Hospital System University Medical Center — Greenville
Illinois
- Illinois Cancer Care, PC — Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03088813
The ClinicalTrials.gov registry entry for NCT03088813 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Topotecan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03088813 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Michigan, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03088813 about?
NCT03088813 is a clinical study titled "Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer". A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection...
What is the current status of trial NCT03088813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 491 participants. The study started on 2018-04-25. Estimated completion is 2023-07-27.
What conditions does trial NCT03088813 study?
This clinical trial studies the following conditions: Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03088813?
The interventions under investigation include: Topotecan (DRUG), Irinotecan liposome injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03088813?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03088813 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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