Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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 mlmin
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT02496585

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 11 Locations for this study

See Locations Near You

Brigham and Women's Hospital (Data Collection Only)
Boston Massachusetts, 02115, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre New York, , United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States
Lehigh Valley Health Network (Data Collection Only)
Allentown Pennsylvania, 18103, United States
MD ANDERSON CANCER CENTER (Data Collection Only)
Houston Texas, 77030, United States
Myriad Genetic Laboratory (Data or Specimen Analysis Only)
Salt Lake City Utah, 84108, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT02496585

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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