Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02496585) involved 34 people in total. Nineteen participants received nintedanib combined with prednisone, and fifteen received a placebo combined with prednisone. The trial was measuring how many people in each group remained free from serious lung flare-ups (called pulmonary exacerbations) — defined as a worsening of symptoms such as cough, breathlessness, or low oxygen levels lasting more than four days, along with new abnormalities visible on a chest scan. The reported data shows that, among those who received nintedanib plus prednisone, 72% were free from these lung flare-ups over the course of the study. In the placebo plus prednisone group, 40% were free from flare-ups. It is worth noting that fewer people completed the study in the nintedanib group (9 out of 19) compared to the placebo group (12 out of 15), and no additional outcome measures were reported in the submitted data. No other outcome measure results were included in the data submitted to ClinicalTrials.gov, so further details about secondary findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Interstitial Lung Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with a cancer in or near the chest (such as a lung, breast, or lymphoma cancer), or cancer that has spread to the lungs, and were treated with the goal of curing or fully controlling the disease at Memorial Sloan Kettering (MSK).
- You completed chest radiation therapy more than 4 weeks ago but no more than 9 months ago before joining the study.
- A CT scan of your chest shows signs of radiation pneumonitis (lung inflammation caused by radiation).
- You have been newly diagnosed with radiation pneumonitis that is rated as moderate or severe (grade 2 or higher) based on standard medical guidelines.
- You are 18 years of age or older.
- You are reasonably able to carry out daily activities, as measured by a standard health scoring tool (confirm with trial site).
- Any short-term side effects from your radiation treatment have mostly cleared up (reduced to a mild level).
- You are willing and able to sign a consent form before joining the study.
Who may not be able to join:
- You have been taking steroid tablets by mouth for more than 4 weeks before signing up.
- You are currently receiving radiation to the chest, or chemotherapy or certain targeted drug treatments for your cancer — although some specific drugs are allowed: Pembrolizumab, Nivolumab, Afatinib, and all hormone therapies.
- Your radiation treatment delivered a high dose of radiation to your esophagus (food pipe) above a certain level (confirm with trial site).
- You have been diagnosed with a widespread form of radiation pneumonitis affecting both lungs broadly.
- You have brain or spinal fluid metastases (cancer that has spread to the brain or lining of the brain/spine) that are untreated or causing symptoms.
- You have cancer that has spread to your liver.
- You have another active cancer that currently needs cancer treatment (note: certain minor skin cancers or early bladder cancers may still be eligible — confirm with trial site).
- Imaging shows that your tumor has hollow or dead areas, or that it is growing into major blood vessels.
- You have an active Hepatitis B or Hepatitis C infection.
- You have a digestive condition that would prevent your body from properly absorbing medication.
- Your liver function blood test results are above certain levels (confirm with trial site).
- Your kidney function results are below certain levels, or there is too much protein in your urine (confirm with trial site).
- You have taken part in another experimental drug study within the past 8 weeks.
- You are pregnant, breastfeeding, or capable of becoming pregnant and not using a highly effective form of birth control for at least one month before joining.
- You are a sexually active male and not willing to use birth control during the study (unless your partner cannot become pregnant).
- You have a known or suspected serious problem with alcohol or drug use that could affect your ability to take part in the trial.
- You have a genetic (inherited) tendency to bleed or form blood clots, or your blood clotting test results are above certain levels (confirm with trial site).
- You have had a significant bleeding episode, blood clot, coughing up blood, active stomach bleeding or ulcers, or major surgery or injury within the past 12 months.
- Your blood counts (white blood cells, platelets, or red blood cells/hemoglobin) are below certain levels (confirm with trial site).
- You are currently taking certain medications, including azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full-dose blood thinners, or high-dose blood-clot-preventing drugs.
- You have had a heart attack within the past 6 months, or unstable chest pain (angina) within the past month.
- You have a known inherited tendency to form blood clots.
- You have had a blood clot event within the past 12 months.
- You have a known tendency to bleed.
- You have serious liver disease.
- You have a history of a hole (perforation) forming in your digestive tract.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Patients Who Are Free From Pulmonary Exacerbations
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.