The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05899725
Status
Unknown

Conditions

  • Severe Checkpoint Inhibitor Pneumonitis

Eligibility Criteria

Sex
ALL
Age
15 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Corticosteroids — DRUG
    Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
  • Corticosteroids and Ruxolitinib — DRUG
    Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence, add-on oral Ruxolitinib 5mg twice a day for 2 weeks, following with Ruxolitinib

Study Details

This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.

Key Dates

Start date
Apr 14, 2023
Status verified
Mar 2024
Primary completion
Mar 1, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: severe CIP with the treatment of corticosteroids
    severe CIP with the treatment of corticosteroids
  • Experimental: Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib
    severe CIP with the treatment of corticosteroids and Ruxolitinib

Primary Outcome Measure

Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1. [ Time Frame: 8 weeks ]

Central Contacts