Immune checkpoint inhibitor-associated lung disorder immune checkpoint inhibitor
Conditions
Interventions
Treatment with prednisolone (1mg/kg/day), tapered over 6 weeks
prednisolone
Sponsors
Suda Takafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with cancer who developed grade 2 or more immune checkpoint inhibitor-associated lung disorder. 2. Patients who require oral steroid therapy for immune checkpoint inhibitor-associated lung disorder. 3. Aged 20 years old or more. 4. Expected life period of 3 months or more. 5. Written informed consent given.
Exclusion criteria
Exclusion criteria: 1. Grade 1 immune checkpoint inhibitor-associated lung disorder, not requiring steroid therapy 2. Lung disorder due to durvalumab after chest chemo-radiotherapy 3. Patients who receive steroids of 10mg or more (prednisolone equivalent), immunosuppressive agents, or anti-fibrosis agents 4. Patients who do not stop anti-cancer treatments during steroid therapy 5. History of interstitial lung disease or drug-induced lung disorder 6. Uncontrolled diabetes 7. Active infectious disease 8. Pregnancy, possibility of pregnancy, or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control rate at 6 weeks after the start of prednisolone treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Control rate at 12 weeks after the start of prednisolone treatment Pneumonitis control rate at 6 and 12 weeks assessed by investigators Progression free survival after the start of prednisolone treatment Time to treatment failure after the start of prednisolone treatment Time to next anti-cancer treatment after the start of prednisolone treatment Overall survival after the start of prednisolone treatment | — |
Contacts
Public ContactMasato Karayama
Hamamatsu University School of Medicine
Outcome results
None listed