6-week prednisolone for ICI-ILD
- Conditions
- Immune checkpoint inhibitor-associated lung disorderimmune checkpoint inhibitor
- Registration Number
- JPRN-jRCT1041190029
- Lead Sponsor
- Suda Takafumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Control rate at 6 weeks after the start of prednisolone treatment
- Secondary Outcome Measures
Name Time Method Control rate at 12 weeks after the start of prednisolone treatment<br>Pneumonitis control rate at 6 and 12 weeks assessed by investigators<br>Progression free survival after the start of prednisolone treatment<br>Time to treatment failure after the start of prednisolone treatment<br>Time to next anti-cancer treatment after the start of prednisolone treatment<br>Overall survival after the start of prednisolone treatment