Skip to main content
OpenTrials
Completed

NCT Number: NCT05899725

The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Respiratory Medicine, Peking Union Medical College Hospita, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old≤ Aged ≤80 years old.
  • Diagnosis of malignancy.
  • 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.
  • Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4.
  • 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

  • Predicted life expectancy<12 weeks.
  • 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.
  • malignancy progression.
  • Patients with other serious complications that may affect safety or adherence judged by the investigator.
  • Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
  • Patients can't fully understand the study protocol, arrangement and other study-related elements.
  • Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
  • Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.
  • Patients who cannot comply with study treatment and follow-up according to the trial protocol.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 8 weeks

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

Secondary outcomes

  1. Mortality

    Time frame: 8 weeks

    Mortality of severe CIP patients at 8 weeks.

  2. Proportion of invasive ventilator assisted respiration

    Time frame: 8 weeks

    Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.

  3. Incidence of pulmonary infection

    Time frame: 8 weeks

    Incidence of pulmonary infection in severe CIP patients in 8 weeks.

  4. Total corticosteroids usage

    Time frame: 8 weeks.

    Total corticosteroids usage for severe CIP patients in 8 weeks.

  5. The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG

    Time frame: 8 weeks.

    The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Second Affiliated Hospital of Nanchang University
  • Shanxi Bethune Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.