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

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