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

Not Applicable

Recruiting

• Conditions: Severe Checkpoint Inhibitor Pneumonitis
• Interventions: Drug: Corticosteroids and Ruxolitinib; Drug: Corticosteroids

• Registration Number: NCT05899725
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Study First Submitted: 2023-06-03
• Study First Submitted QC: 2023-06-03
• Study First Posted: 2023-06-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 18 years old≤ Aged ≤80 years old.
2. Diagnosis of malignancy.
3. Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) in combination with or without chemotherapy.
4. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4.
5. Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent.

Exclusion Criteria

1. Predicted life expectancy<12 weeks.
2. Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment.
3. malignancy progression.
4. Patients with other serious complications that may affect safety or adherence judged by the investigator.
5. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
6. Patients can't fully understand the study protocol, arrangement and other study-related elements.
7. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
8. Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.
9. Patients who cannot comply with study treatment and follow-up according to the trial protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib	Corticosteroids and Ruxolitinib	severe CIP with the treatment of corticosteroids and Ruxolitinib
Cohort 1: severe CIP with the treatment of corticosteroids	Corticosteroids	severe CIP with the treatment of corticosteroids

Primary Outcome Measures

Name	Time	Method
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.	8 weeks	Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.

Secondary Outcome Measures

Name	Time	Method
Mortality	8 weeks	Mortality of severe CIP patients at 8 weeks.
Proportion of invasive ventilator assisted respiration	8 weeks	Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Incidence of pulmonary infection	8 weeks	Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Total corticosteroids usage	8 weeks.	Total corticosteroids usage for severe CIP patients in 8 weeks.
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG	8 weeks.	The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.

Trial Locations

Locations (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita; 🇨🇳 Beijing, Beijing, China