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

NCT02496585 | Completed Phase 2 Results

• 1 other identifier: 14-167
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 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

Keywords

Nintedanib (BIBF 1120); Prednisone; Radiation Pneumonitis

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Are Free From Pulmonary Exacerbations

  An acute exacerbation will be defined as (all criteria must be met): 1. Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days 2. New or worsening diffuse pulmonary infiltrates on chest CT (with or without contrast) or new high resolution CT parenchymal abnormalities without significant pneumothorax or pleural effusion

  12 months

Study Arms (2)

Nintedanib + Prednisone

EXPERIMENTAL

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).

Drug: Nintedanib; Drug: Prednisone

Placebo + Prednisone

EXPERIMENTAL

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).

Drug: Prednisone; Other: Placebo

Interventions

Nintedanib DRUG

Also known as: BIBF 1120

Nintedanib + Prednisone

Prednisone DRUG

Nintedanib + Prednisone; Placebo + Prednisone

Placebo OTHER

Placebo + Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (12)

Brigham and Women's Hospital (Data Collection Only)

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, 18103, United States

Location

MD ANDERSON CANCER CENTER (Data Collection Only)

Houston, Texas, 77030, United States

Location

Myriad Genetic Laboratory (Data or Specimen Analysis Only)

Salt Lake City, Utah, 84108, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Radiation Pneumonitis

Interventions

nintedanib; Prednisone

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Zachary Moore, MD, PhD
• Organization: Memorial Sloan Kettering Cancer Center

moorez@mskcc.org

929-687-0151

Study Officials

• Zachary Moore, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: July 8, 2015
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2024-04

Locations

US (12)