NCT03088813

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan liposome injection	IV
DRUG	Topotecan	IV

Timeline

• Start date: 2018-04-25
• Primary completion: 2022-02-08
• Completion: 2023-07-27
• First posted: 2017-03-23
• Last updated: 2025-02-19
• Results posted: 2023-10-17

Locations

118 sites across 18 countries: United States, Australia, Belgium, Brazil, China, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study