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NCT04173325 · ClinicalTrials.gov registry record · Phase 1
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
A Phase 1 study, sponsored by Augusta University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04173325: Clinical Trial Phase 1 study, sponsored by Augusta University.
NCT04173325 is a Phase 1 study that was terminated before completion, run by Augusta University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173325, a Phase 1 study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Primary Outcome
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Interventions
- DRUG Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
- DRUG Irinotecan Injection [Camptosar]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2022-05-26 |
| Phase | Phase 1 |
Why NCT04173325 stopped before completion
NCT04173325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] is the first listed.
NCT04173325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04173325 about?
NCT04173325 is a clinical study titled "Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer". This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together a...
What is the current status of trial NCT04173325?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-01-06. Estimated completion is 2022-05-26.
What interventions are being tested in trial NCT04173325?
The interventions under investigation include: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] (DRUG), Irinotecan Injection [Camptosar] (DRUG).
Who is sponsoring clinical trial NCT04173325?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04173325's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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