Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03098030 | Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer | PHASE2 | COMPLETED | 483 | — | — | Jun 1, 2017 | Mar 26, 2020 | Dec 9, 2020 | 226 | United States, Australia +21 |
OS will be derived as: (date of death - date of randomization) + 1. Subjects who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the subject was known to be alive.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dinutuximab + Irinotecan | EXPERIMENTAL | Dinutuximab (10 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. |
| Part 2: Irinotecan | ACTIVE_COMPARATOR | Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. |
| Part 2: Dinutuximab + Irinotecan | EXPERIMENTAL | Dinutuximab (16 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. |
| Part 2: Topotecan | ACTIVE_COMPARATOR | Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle. |
| Name | Type | Description |
|---|---|---|
| Dinutuximab | BIOLOGICAL | Dinutuximab injection, for intravenous (IV) use |
| Irinotecan | DRUG | Irinotecan injection, IV infusion |
| Topotecan | DRUG | Topotecan for injection |
Inclusion Criteria: 1. Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin). 2. Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinu...