Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

Inclusion Criteria:

Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK
Prior treatment with thoracic radiotherapy completed >4 weeks and ≤ 9 months prior to enrollment
Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast
Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria
Age≥18 years
KPS > 70%
Reduction of any acute toxicity from radiation treatment to grade 1
Written informed consent signed prior to entry into the study

Exclusion Criteria:

Current oral steroid use > 4 weeks prior to registration
Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy, except the following therapies which are permitted: Pembrolizumab, Nivolumab, Afatinib and all hormonal therapies.
Mean esophageal radiation dose >45 Gy
Diagnosis of diffuse radiation pneumonitis
Untreated or symptomatic brain metastases or leptomeningeal disease
Liver metastases
Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible)
Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
Active chronic Hepatitis C and/or B infection
Gastrointestinal disorders that would interfere with drug absorption
AST > 1.5 x ULN, ALT>1.5 x ULN and Bilirubin > 1.5 x ULN
≥ Grade 2 proteinuria, creatinine >1.5x ULN or GFR <45 ml/min
Other investigational therapy received within 8 weeks prior to screening visit
Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment1
Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
Conditions that may affect the patient's ability to participate in this trial, e.g. known or suspected active alcohol or drug abuse
Inherited predisposition to bleeding or thrombosis, INR >2, PT and PTT >1.5x ULN
History of bleeding disorders or thrombotic events, e.g. hemorrhagic or thrombotic events within 12 months, clinically significant or tumor-related hemoptysis, active gastrointestinal bleeding or ulcers or major injuries or surgery
ANC < 1.5 K/mcL, Platelets < 100 K/mcL, Hemoglobin < 9.0 g/dl
Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin, etc.), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150mg)^2 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively
Known inherited predisposition to thrombosis
Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
Known predisposition to bleeding
Patients with severe hepatic impairment
History of a gastrointestinal perforation