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

NCT ID: NCT02496585

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-08
• Study Completion Date: 2024-04-12

Brief 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.

Conditions

Lung Cancer; Lung Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nintedanib + Prednisone

The initial dose of nintedanib will be 150mg two times per day orally according to study protocol. Nintedanib will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Placebo + Prednisone

Placebo will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Interventions

Nintedanib

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

BIBF 1120

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zachary Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Brigham and Women's Hospital (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States

MD ANDERSON CANCER CENTER (Data Collection Only)

Houston, Texas, United States

Myriad Genetic Laboratory (Data or Specimen Analysis Only)

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-167

Identifier Type: -

Identifier Source: org_study_id