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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

The study was conducted in two parts: Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were planned to be enrolled. Part 1 Primary Objectives: - Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks - Determine the optimal irinotecan liposome injection monotherapy dose for Part 2 of this study Part 2: A randomized, efficacy study of irinotecan liposome injection versus intravenous (IV) topotecan. Approximately 450 patients were planned to be enrolled in part 2. Part 2 objectives: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03088813
Study type Interventional
Source Ipsen
Contact
Status Completed
Phase Phase 3
Start date April 25, 2018
Completion date July 27, 2023
View Details
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