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

The Efficacy and Safety of Corticosteroids in Combination With Biological Agents in the Management of Severe Immune Related Adverse Events Cohort A: The Efficacy and Safety of Corticosteroids or Corticosteroids Combination With Ruxolitinib in Patients With Severe Checkpoint Inhibitor Pneumonia

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Checkpoint Inhibitor Pneumonitis
• Intervention / Treatment: Drug: Corticosteroids; Drug: Corticosteroids and Ruxolitinib

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Xu; Phone Number: +861069155154; Email: maraxu@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Department of Respiratory Medicine, Peking Union Medical College Hospita
      • Contact: Mengzhao Wang, MD; Phone Number: +86 010-69155039; Email: mengzhaowang@sina.com
      • Sub-Investigator: Wei Zhong, MD
      • Contact: Yan Xu, MD; Phone Number: +86 18500296828; Email: maraxu@163.com
      • Sub-Investigator: Yan Xu, MD
      • Sub-Investigator: Minjiang Chen, MD
      • Sub-Investigator: Jing Zhao, MD
      • Sub-Investigator: Huang Hui, MD
      • Sub-Investigator: Xiaoxing Gao, MD
      • Sub-Investigator: Xiaoyan Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1: severe CIP with the treatment of corticosteroids; severe CIP with the treatment of corticosteroids	Drug: Corticosteroids; Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
Experimental: Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib; severe CIP with the treatment of corticosteroids and Ruxolitinib	Drug: Corticosteroids and Ruxolitinib; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 3, 2023
• First Submitted That Met QC Criteria: June 3, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: K22C2678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No