Last updated on July 2020

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


Brief description of study

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 will be conducted in two parts:

  1. Dose determination of irinotecan liposome injection
  2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

Detailed Study Description

The study will be conducted in two parts:

Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were 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 IV topotecan.

Approximately 450 patients will be enrolled in part 2.

Part 2 objectives: Detailed in the Primary & Secondary outcome measure sections.

Clinical Study Identifier: NCT03088813

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Recruitment Status: Open


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