At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 491 enrolled
Drug / intervention
Irinotecan liposome injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Irinotecan liposome injection and Topotecan for Small Cell Lung Cancer. Completed, enrolled 491 participants across 118 sites in 18 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesAustralia, Belgium, Brazil, China, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartApr 2018
Primary CompletionFeb 2022
Study CompletionJul 2023
TodayJul 2026
First PostedMar 23, 2017
Enrollment StartApr 25, 2018
Primary CompletionFeb 8, 2022
Study CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.3 years ago
Interventions
Irinotecan liposome injectiondrug
IV
Topotecandrug
IV