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Completed Phase 3 Interventional Results available

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT03088813

Public ClinicalTrials.gov record NCT03088813. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

RESILIENT: 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT03088813
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ipsen
Industry
Enrollment
491 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 25, 2018 (Actual)
Primary completion
Feb 8, 2022 (Actual)
Completion
Jul 27, 2023 (Actual)
Last update posted
Feb 19, 2025

2018 – 2023

United States locations

U.S. sites
22
U.S. states
13
U.S. cities
20
Facility City State ZIP Site status
National Jewish Health Denver Colorado 80206 —
Rocky Mountain Cancer Centers Denver Colorado 80218 —
Florida Cancer Specialists (South Region) Fort Myers Florida 33916 —
Florida Cancer Specialists St. Petersburg Florida 33705 —
Northwest Georgia Oncology Centers Marietta Georgia 30060 —
Cancer Treatment Centers of America-Georgia Newnan Georgia 30265 —
Illinois Cancer Care, PC Peoria Illinois 61615 —
Southern Maine Health Care Biddeford Maine 04005 —
University of Maryland Medical Group Baltimore Maryland 21201 —
Henry Ford Hospital Detroit Michigan 48202 —
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan 49503 —
Sparrow Regional Cancer Center Lansing Michigan 48219 —
Roswell Park Cancer Institute Buffalo New York 14263 —
North Shore Hematology Oncology Associates, PC East Setauket New York 11733 —
Case Western Reserve University Cleveland Ohio 44106 —
Tri County Hematology & Oncology Associates, Inc Massillon Ohio 44646 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Charleston Hematology Oncology Associates, PA Charleston South Carolina 29414 —
Greenville Hospital System University Medical Center Greenville South Carolina 29605 —
Tennessee Oncology Nashville Tennessee 37203 —
MultiCare Health System Institute for Research and Innovation Spokane Washington 99204 —
Summit Cancer Treatment Center Spokane Washington 99208 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03088813, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 19, 2025 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03088813 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →