6-week prednisolone for ICI-ILD

JRCT ID: jRCT1041190029

Registered date:24/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Immune checkpoint inhibitor-associated lung disorder
• Date of first enrollment: 29/05/2019
• Target sample size: 55
• Study type: Interventional
• Intervention(s): Treatment with prednisolone (1mg/kg/day), tapered over 6 weeks

Outcome(s)

• Primary Outcome: Control rate at 6 weeks after the start of prednisolone treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Suda Takafumi