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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 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 483 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03098030
The ClinicalTrials.gov registry entry for NCT03098030 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 483 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Irinotecan is the first listed.
NCT03098030 reports 0 study locations.
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.
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