Trial · NCT02496585
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
NCT02496585, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2025-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis. Trials, record NCT02496585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02496585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
- NCT number
- NCT02496585
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Lung Cancer, Lung Metastases
- Interventions
- Nintedanib, Prednisone, Placebo
- First posted
- 2015-07-14
- Last updated
- 2025-04-16
- Results first posted
- 2025-04-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Are Free From Pulmonary Exacerbations | 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 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Are Free From Pulmonary Exacerbations | 12 months | percental of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Are Free From Pulmonary Exacerbations | Nintedanib + Prednisone | 72 | 95% Confidence Interval 54 to 96 | percental of participants | |
| Number of Patients Who Are Free From Pulmonary Exacerbations | Placebo + Prednisone | 40 | 95% Confidence Interval 20 to 82 | percental of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib + Prednisone | 19 | |
| Overall Study | STARTED | Placebo + Prednisone | 15 | |
| Overall Study | COMPLETED | Nintedanib + Prednisone | 9 | |
| Overall Study | COMPLETED | Placebo + Prednisone | 12 | |
| Overall Study | NOT COMPLETED | Nintedanib + Prednisone | 10 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisone | 3 |
Source ClinicalTrials.gov
Adverse events208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib + Prednisone | 1 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Prednisone | 1 | 12 | |
| other | Agitation | Psychiatric disorders | Nintedanib + Prednisone | 1 | 18 | |
| other | Agitation | Psychiatric disorders | Placebo + Prednisone | 0 | 12 | |
| other | Alanine aminotransferase increased | Investigations | Nintedanib + Prednisone | 2 | 18 | |
| other | Alanine aminotransferase increased | Investigations | Placebo + Prednisone | 0 | 12 | |
| other | Anemia | Blood and lymphatic system disorders | Nintedanib + Prednisone | 2 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo + Prednisone | 1 | 12 | |
| other | Anorexia | Metabolism and nutrition disorders | Nintedanib + Prednisone | 3 | 18 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo + Prednisone | 2 | 12 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib + Prednisone | 8 | 18 |
| Total, all-cause mortality | Placebo + Prednisone | 3 | 12 |
| Total, other adverse events | Nintedanib + Prednisone | 18 | 18 |
| Total, other adverse events | Placebo + Prednisone | 12 | 12 |
| Total, serious adverse events | Nintedanib + Prednisone | 7 | 18 |
| Total, serious adverse events | Placebo + Prednisone | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nintedanib + Prednisone vs Placebo + Prednisone: deaths from any cause | Trial comparisons |
| Nintedanib + Prednisone vs Placebo + Prednisone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02496585
GET https://conductscience.org/api/trials/v1/NCT02496585/events?page=2