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MM-339-01-03-04 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

NCT03088813

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

Associated Conditions

Lung Cancer

Principal Investigator

Sponsor

IPSEN Bioscience

This study will take place in 2 parts (Part 1 and Part 2). The purpose of Part 1 is to find out what is the best dose of irinotecan liposome injection to be used in Part 2 of the study. Once the best dose is found, Part 1 will be closed to enrollment and Part 2 will open. The purpose of Part 2 is to see how effective and safe the study drug is at treating subjects with small cell lung cancer. This will be done by comparing the effects of the study drug with the effects of topotecan. Topotecan is approved for the treatment of small cell lung cancer.