Lung Cancer DIV-SCLC-301

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 compared with irinotecan alone. Subjects in Part 2 will be randomized into 3 different treatment groups.

Eligibility Criteria:

The patient must have histological (tissue microscopically examined) or cytological (fluid cells microscopically examined) confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin). There must be documented relapse or disease progression during or after first-line platinum-based therapy.

This study is for patients age 18 and older.

Available at: Hartford Hospital, the Hospital of Central Connecticut, Midstate Medical Center, and Backus Hospital

Cancer Clinical Research Office