Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
Status:
Completed
Trial end date:
2020-03-26
Target enrollment:
Participant gender:
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).