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

Official Title

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

Summary:

This is a 2-part, multicentre, 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).

Trial Description

Primary Outcome:

  • Overall survival (OS)
Secondary Outcome:
  • Progression-free survival (PFS)
  • Objective response rate (ORR)
  • Clinical benefit rate (CBR)
  • Area under the concentration versus time curve (AUC) of dinutuximab
  • Maximum concentration (Cmax) of dinutuximab
  • Halt-life (t1/2) of dinutuximab
  • Clearance (CL) of dinutuximab
  • Incidence of adverse events
  • Incidence of toxicities

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society