Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT03098030Phase 2/3Completed
- Lead sponsor
- United Therapeutics (Industry)
- Enrollment
- 483 (actual)
- Start date
- 1 Jun 2017
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 26 Mar 2020
- Last update posted
- 9 Dec 2020
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 4
Interventions
- Dinutuximab Biological
- Irinotecan Drug
- Topotecan Drug
Conditions and primary outcome
- Small Cell Lung Cancer
Primary outcome
Overall Survival (OS) (Up to approximately 2.5 years)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03098030 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Adverse events (AEs) were collected for all enrolled subjects beginning with first dose of study medication. Serious adverse events (and AEs based on local regulations) were to be collected starting on the day of written informed consent. In addition to reporting while on study therapy, adverse events were required to be reported through 30 days after the last dose of study therapy.
| Group | Affected | At risk |
|---|---|---|
| Part 1: Dinutuximab + Irinotecan | 5 | 12 |
| Part 2: Dinutuximab + Irinotecan | 74 | 183 |
| Part 2: Irinotecan | 76 | 187 |
| Part 2: Topotecan | 39 | 88 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedRandomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer.
Lung cancer (Amsterdam, Netherlands) · 2022 Apr
PubMed 35278766 (opens in a new tab)DOI 10.1016/j.lungcan.2022.03.003 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03098030 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.