lung cancer, malignant mesothelioma lung cancer
Conditions
Interventions
CTCAE v5.0 grade 2 pneumonitis
Patients will receive oral or intravenous prednisolone (1mg/kg/day) for 14 days.
CTCAE v5.0 grade 3 pneumonitis
Patients will receive intravenous prednisolone (2mg/kg/
Sponsors
Nobuyuki Hizawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| CTCAE v5.0 pneumonitis grade at the end of prednisolone therapy. Toxicity Overall survival from the start of immune checkpoint inhibitors treatment Efficacy by CTCAE v5.0 pneumonitis grade Solubulate interleukin 2 receptor Bronchoalveolar lavage fluid | — |
Contacts
Public ContactShiozawa Toshihiro
Faculty of Medicine, University of Tsukuba
Outcome results
None listed