Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer (RESILIENT)
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|ClinicalTrials.gov Identifier: NCT03088813|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : July 28, 2021
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:
- Dose determination of irinotecan liposome injection
- A randomized, efficacy study of irinotecan liposome injection versus topotecan
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Irinotecan liposome injection Drug: Topotecan||Phase 2 Phase 3|
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: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with intravenous (IV) topotecan.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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|
|Actual Study Start Date :||April 25, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Experimental Arm
Irinotecan liposome injection
Drug: Irinotecan liposome injection
Other Name: ONIVYDE®
Active Comparator: Control Arm
- Overall survival (OS) [ Time Frame: 40 months ]Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.
- Progression-free survival [ Time Frame: 40 months ]Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first
- Objective Response [ Time Frame: 40 months ]Objective response is defined as the time from randomization to date of progression or death. Objective response rate (ORR) is the proportion of patients who achieve partial response or complete response according to RECIST v1.1 guidelines
- Quality of Life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-C30/LC13) dyspnea scale [ Time Frame: Baseline to week 12 ]
- Quality of Life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) cough scale [ Time Frame: Baseline to week 12 ]
- Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities [ Time Frame: Enrollment to 30 days after permanent treatment termination ]Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088813
|Study Director:||Ipsen Medical Director||Ipsen|