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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNintedanib and Prednisone

Plus 1 other study approaches.

Who it may be forLung Cancer · Lung Metastases

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 16, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: Nintedanib; Drug: Prednisone; Other: Placebo

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Study topics

Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Brigham and Women's Hospital (Data Collection Only)Boston, Massachusetts
Memorial Sloan Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey
Memorial Sloan Kettering MonmouthMiddletown, New Jersey
Memorial Sloan Kettering BergenMontvale, New Jersey
Memorial Sloan Kettering Cancer Center @ SuffolkCommack, New York
Memorial Sloan Kettering WestchesterHarrison, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
Memorial Sloan Kettering at Mercy Medical CenterRockville Centre, New York
Memorial Sloan Kettering NassauUniondale, New York
Lehigh Valley Health Network (Data Collection Only)Allentown, Pennsylvania
MD ANDERSON CANCER CENTER (Data Collection Only)Houston, Texas
Myriad Genetic Laboratory (Data or Specimen Analysis Only)Salt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 16, 2025. Always confirm current availability with the study team.

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