NCT03098030

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Dinutuximab	Dinutuximab injection, for intravenous (IV) use
DRUG	Irinotecan	Irinotecan injection, IV infusion
DRUG	Topotecan	Topotecan for injection

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-01-27
• Completion: 2020-03-26
• First posted: 2017-03-31
• Last updated: 2020-12-09
• Results posted: 2020-12-09

Locations

226 sites across 23 countries: United States, Australia, Bulgaria, Canada, France, Georgia, Hong Kong, Hungary, India, Italy, Lithuania, Malaysia, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study