Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dinutuximab · 1 trial · 1 indication
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...
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Dinutuximab is a monoclonal antibody being studied for the treatment of relapsed or refractory Small Cell Lung Cancer. It is currently in Phase 2 clinical development and is being evaluated in combination with irinotecan compared to irinotecan alone in patients with this condition.
Dinutuximab is being developed by United Therapeutics Corporation, which trades under the ticker symbol UTHR. The company is conducting clinical research on this monoclonal antibody for the treatment of Small Cell Lung Cancer.
Dinutuximab is in Phase 2 clinical development for Small Cell Lung Cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and efficacy.
Dinutuximab has been studied in one clinical trial with the identifier NCT03098030. This Phase 2 trial, titled "Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer," enrolled 483 participants and has been completed.
Dinutuximab is a monoclonal antibody that targets a specific antigen on cancer cells. By binding to this target, it helps the immune system recognize and attack the cancer cells. In the context of Small Cell Lung Cancer, it is being tested in combination with chemotherapy.