At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Nintedanib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
In Brief
A Phase 2 clinical trial evaluating Nintedanib, Prednisone, and 1 other intervention for Lung Cancer and Lung Metastases. Completed, enrolled 34 participants across 12 sites.
Detailed Summary
The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Lung Metastases
CountriesUnited States
CollaboratorsBoehringer Ingelheim
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionApr 2024
TodayJul 2026
First PostedJul 14, 2015
Enrollment StartJul 8, 2015
Primary CompletionApr 12, 2024
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 11.0 years ago
Interventions
Nintedanibdrug
Prednisonedrug
Placeboother