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NCT02452463 · ClinicalTrials.gov registry record · Phase 2
Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02452463: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT02452463 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02452463, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This trial studies the side effects and how well nintedanib works compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and may prevent the growth of new blood vessels. It may also help reduce the recurrence of non-small cell lung cancer.
Primary Outcome
Will compare the rate of symptomatic radiation pneumonitis in patients who received nintedanib versus placebo. Assessed using the intent-to-treat principle and a one-sided exact test about the Cochran-Mantel-Haenszel correlation and regression test. The grade 2 or higher radiation penumonitis is identified by the Common Terminology Criteria for Adverse Events.
Interventions
- OTHER Placebo
- BIOLOGICAL Durvalumab
- PROCEDURE Quality-of-Life Assessment
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-06-29 |
| Est. Completion | 2019-06-10 |
| Phase | Phase 2 |
Why NCT02452463 stopped before completion
NCT02452463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02452463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02452463 about?
NCT02452463 is a clinical study titled "Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy". This trial studies the side effects and how well nintedanib works compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are undergoing chemoradiation therapy. Nintedanib ma...
What is the current status of trial NCT02452463?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2015-06-29. Estimated completion is 2019-06-10.
What interventions are being tested in trial NCT02452463?
The interventions under investigation include: Placebo (OTHER), Durvalumab (BIOLOGICAL), Quality-of-Life Assessment (PROCEDURE), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT02452463?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02452463's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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