Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis (NCT NCT02496585)
NCT ID: NCT02496585
Last Updated: 2025-04-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
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).
Nintedanib
Prednisone
|
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).
Prednisone
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
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).
Nintedanib
Prednisone
|
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).
Prednisone
Placebo
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Progression of Malignancy
|
4
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
Baseline characteristics by cohort
| Measure |
Nintedanib + Prednisone
n=18 Participants
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).
Nintedanib
Prednisone
|
Placebo + Prednisone
n=12 Participants
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).
Prednisone
Placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
70 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAn 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
Outcome measures
| Measure |
Nintedanib + Prednisone
n=18 Participants
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).
Nintedanib
Prednisone
|
Placebo + Prednisone
n=12 Participants
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).
Prednisone
Placebo
|
|---|---|---|
|
Number of Patients Who Are Free From Pulmonary Exacerbations
|
72 percental of participants
Interval 54.0 to 96.0
|
40 percental of participants
Interval 20.0 to 82.0
|
Adverse Events
Nintedanib + Prednisone
Serious events: 7 serious events
Other events: 18 other events
Deaths: 8 deaths
Placebo + Prednisone
Serious events: 1 serious events
Other events: 12 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Nintedanib + Prednisone
n=18 participants at risk
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).
Nintedanib
Prednisone
|
Placebo + Prednisone
n=12 participants at risk
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).
Prednisone
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Infections and infestations
Lung infection
|
16.7%
3/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
General disorders
Pain
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Psychiatric disorders
Psychosis
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Infections and infestations
Shingles
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
Other adverse events
| Measure |
Nintedanib + Prednisone
n=18 participants at risk
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).
Nintedanib
Prednisone
|
Placebo + Prednisone
n=12 participants at risk
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).
Prednisone
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
2/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
3/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
4/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Cardiac disorders
Cardiac arrest
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
2/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • 12 months
|
33.3%
4/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
61.1%
11/18 • 12 months
|
66.7%
8/12 • 12 months
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
61.1%
11/18 • 12 months
|
41.7%
5/12 • 12 months
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Gastrointestinal disorders
Dry throat
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
3/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
72.2%
13/18 • 12 months
|
91.7%
11/12 • 12 months
|
|
General disorders
Edema limbs
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Investigations
Elevated liver enzymes
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Esophagitis
|
11.1%
2/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
General disorders
Fatigue
|
50.0%
9/18 • 12 months
|
66.7%
8/12 • 12 months
|
|
General disorders
Fever
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
General disorders
Gait disturbance
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Vascular disorders
Hypotension
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
General disorders
Influenza Type A
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left mid back mass
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
Liver enzyme elevations
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Infections and infestations
Lung infection
|
16.7%
3/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Lymphocyte count decreased
|
11.1%
2/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
General disorders
Malaise
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Nervous system disorders
Neuralgia
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
General disorders
Pain
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Injury, poisoning and procedural complications
Parenchymal changes
|
16.7%
3/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
4/18 • 12 months
|
25.0%
3/12 • 12 months
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
3/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
38.9%
7/18 • 12 months
|
50.0%
6/12 • 12 months
|
|
Gastrointestinal disorders
Polyphagia
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
2/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Psychiatric disorders
Psychosis
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
33.3%
6/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Infections and infestations
Shingles
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Nervous system disorders
Spasticity
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Infections and infestations
Tracheitis
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Nervous system disorders
Tremor
|
11.1%
2/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • 12 months
|
0.00%
0/12 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • 12 months
|
8.3%
1/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/18 • 12 months
|
16.7%
2/12 • 12 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/18 • 12 months
|
8.3%
1/12 • 12 months
|
Additional Information
Dr. Zachary Moore, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 929-687-0151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place