Lung CancerPhase 2NCT02496585
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
A Phase 2 study testing Nintedanib and Prednisone in people with Lung Cancer and Lung Metastases, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Metastases
- What is being tested?
- Nintedanib and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Jul 2015to 12 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07920
Brigham and Women's Hospital (Data Collection Only)
Boston, Massachusetts, 02115
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
MD ANDERSON CANCER CENTER (Data Collection Only)
Houston, Texas, 77030
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Myriad Genetic Laboratory (Data or Specimen Analysis Only)
Salt Lake City, Utah, 84108
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
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
- Being tested
- Nintedanib, Prednisone, Placebo
- Keywords
- Nintedanib (BIBF 1120), Prednisone, Radiation Pneumonitis
- Medical subject headings
- Lung Neoplasms, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Also called BIBF 1120
PrednisoneDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Prednisone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Are Free From Pulmonary Exacerbations
An acute exacerbation will be defined as (all criteria must be met):
- Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
- 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start8 Jul 2015
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Zachary Moore, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496585
- Sponsor's protocol ID
- 14-167
- Status last verified
- Apr 2024
- First submitted
- 9 Jul 2015
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
- ClinicalTrials.gov ID
- NCT02496585
- Acronym / sponsor ID
- 14-167
- Conditions
- Lung Cancer, Lung Metastases
- Keywords
- Nintedanib (BIBF 1120), Prednisone, Radiation Pneumonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib + Prednisone | Experimental | Drug: Nintedanib, Drug: PrednisoneThe 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). |
| Placebo + Prednisone | Experimental | Drug: Prednisone, Other: PlaceboPlacebo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibAlso: BIBF 1120 | Drug | Nintedanib + Prednisone |
| Prednisone | Drug | Nintedanib + Prednisone, Placebo + Prednisone |
| Placebo | Other | Placebo + Prednisone |
Primary outcome
Number of Patients Who Are Free From Pulmonary Exacerbations
Time frame: 12 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Moore, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nintedanib and Prednisone in people with Lung Cancer and Lung Metastases, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Are Free From Pulmonary Exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.