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

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 involved 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).

Key inclusion criteria include:

• Age ≥18 years
• Histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin)
• Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinumbased therapy are eligible)
• Have a life expectancy of at least 12 weeks
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria include:

• Candidate for re-treatment with original platinum-based regimen as second-line therapy
• Prior treatment with irinotecan, topotecan, or dinutuximab
• Active brain metastases; subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation
• Have mixed small cell and non-small cell histologic features

Target enrollment is 470 patients.

For questions, email DISTINCT@unither.com.