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Protocol No. UW17108

Principal Investigator Leal, Ticiana

Phase II/III

Age Group Adult

Scope National

Sponsor Type Industry

Title A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer

Objective You will be participating in Part 2 of this study. In this part of the study, we want to find out if the combination of two drugs, dinutuximab and irinotecan, is a better treatment than either irinotecan alone or topotecan alone for the type of cancer you have. Topotecan has been approved by the US Food and Drug Administration (FDA) for the treatment of the type of cancer you have. The combination of dinutuximab and irinotecan is not approved by the FDA and considered investigational treatment of the type of cancer you have, and can only be given in a research study

Treatment You will be randomly assigned (by a computer program) to one of three treatment groups by chance (like the flip of a coin). Neither you nor your study doctor can choose which group you are assigned. You will be told which group you are in and will not be able to change to another group during the course of the study. Whichever group you are assigned to, you will still receive a standard of care SCLC treatment (either irinotecan or topotecan). You will have a 2 in 5 (40%) chance of being assigned to irinotecan alone, a 2 in 5 (40%) chance of being assigned to the investigational drug dinutuximab plus irinotecan, and a 1 in 5 (20%) chance of being assigned to topotecan alone. You will receive study treatment (irinotecan, dinutuximab + irinotecan, or topotecan) during the study until you are no longer benefiting from or tolerating these treatments.
  • Group A: Irinotecan alone
  • Group B: Dinutuximab + Irinotecan
  • Group C: Topotecan alone

  • Description Open-label, randomized, phase II/III study using Dinutuximab and Irinotecan versus Irinotecan, second line treatment for Relapsed or Refractory Small Cell Lung Cancer

    Key Eligibility
  • Histologically or cytologically confirmed SCLC (undifferentiated small cell carcinoma arising in or consistent with lung cancer origin)
  • Documented (radiographic evidence of) relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible)
  • No more than 1 prior regimen for SCLC. First-line platinum-based therapy followed by maintenance therapy is considered a single regimen provided there is no intervening disease progression
  • Have no curative therapy available.
  • Have a life expectancy of at least 12 weeks.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow function, hepatic function and calculated creatinine clearance
  • Women of reproductive potential must agree to consistently use one form of highly effective contraception
  • No prior treatment with irinotecan, topotecan or dinutuximab
  • No active brain metastases
  • No mixed small-cell and non-small-cell histologic features
  • No history or current evidence of uncontrolled cardiovascular disease
  • No history of atypical thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
  • No prior organ allograft or hematopoietic transplantation
  • Can not be HIV positive (human immunodeficiency virus)
  • No active infection requiring treatment

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics