Full TitlePhase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients with Radiation Pneumonitis
Radiation pneumonitis is a complication that occurs in about one out of five patients receiving radiation therapy to the lungs. It causes lung inflammation and can eventually cause lung scarring. Radiation pneumonitis is typically treated with steroids like prednisone, which works in the short term, but it is unclear if steroid therapy can prevent the long-term consequences of pneumonitis.
In this study, researchers want to see if adding the investigational drug nintedanib (BIBF 1120) to prednisone therapy is more effective than prednisone alone. Other studies have suggested that nintedanib may be effective for reducing similar types of lung injury. Patients in this study will be randomly assigned to receive nintedanib or a placebo (inactive pill) in addition to prednisone. Both nintedanib and prednisone are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have developed grade 2 radiation pneumonitis from radiation therapy for thoracic tumors, including lung cancer, thymoma, mesothelioma, breast cancer, lymphoma, or lung metastases.
- Radiation therapy must have been completed more than 4 weeks but no more than 9 months before the diagnosis of radiation pneumonitis.
- This study is for patients age 18 and older.