Clinical trial of prednisolone for immune related interstitial lung disease
- Conditions
- lung cancer, malignant mesotheliomalung cancer
- Registration Number
- JPRN-jRCTs031210327
- Lead Sponsor
- obuyuki Hizawa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
1. Histologically confirmed non-small cell lung cancer or maligmamt mesothelioma.
2. Patients who developed drug induced interstitial lung disease with CTCAE v5.0 grade 2 or 3 during immune checkpoint inhibitors (ICIs) or within 3 months from the last day of ICIs administrarion.
3. Required systemic corticosteroid therapy for drug induced interstitial lung disease.
4. The age is over 20 years.
5. Patients providing the written informed consent.
1. Active comorbidity that has required continuous systemic corticosteroid or other immunosupressive agents
2. Patients with severe respiratory complication or received home oxygen therapy.
3. Patients with active infection.
4. Psychological disorder difficult to participate in this clinical study.
5. Uncontroled diabetes melitus
6. Female patients with pregnant.
7. Patients who recieve desmopressin.
8. Other immune related adverse events that has required systemic steroid therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of cases in which CTCAE v5.0 pneumonitis grade on day 14 of prednisolone treatment improved by more than one levels from the time of regstration.
- Secondary Outcome Measures
Name Time Method CTCAE v5.0 pneumonitis grade at the end of prednisolone therapy.<br>Toxicity<br>Overall survival from the start of immune checkpoint inhibitors treatment<br>Efficacy by CTCAE v5.0 pneumonitis grade<br>Solubulate interleukin 2 receptor<br>Bronchoalveolar lavage fluid