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NCT03098030 · ClinicalTrials.gov registry record · Phase 2
Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 483
- Enrollment target
NCT03098030: Completed Phase 2 study, sponsored by United Therapeutics.
NCT03098030 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 483 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (263% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03098030, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 483 participants
- Enrollment target
Study Summary
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 (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).
Primary Outcome
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.
Interventions
- DRUG Irinotecan
- DRUG Topotecan
- BIOLOGICAL Dinutuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 483 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-03-26 |
| Phase | Phase 2 |
What the finished NCT03098030 record still lists
NCT03098030 is an interventional study that assigns participants to a tested intervention. The registered 483 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (263% higher).
The record links to 0 conditions, and to 3 interventions - of which Irinotecan is the first listed.
NCT03098030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03098030 about?
NCT03098030 is a clinical study titled "Dinutuximab and Irinotecan Versus Irinotecan to Treat 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 involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in...
What is the current status of trial NCT03098030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 483 participants. The study started on 2017-06-01. Estimated completion is 2020-03-26.
What interventions are being tested in trial NCT03098030?
The interventions under investigation include: Irinotecan (DRUG), Topotecan (DRUG), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03098030?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03098030's enrollment target sits among peer trials
483 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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