Combining corticosteroids with Ruxolitinib for severe lung inflammation from cancer treatment

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 testing whether adding Ruxolitinib to corticosteroids can help people with severe lung inflammation caused by cancer treatment feel better and stay safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 15 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Ruxolitinib
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05899725 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of corticosteroids alone versus corticosteroids combined with Ruxolitinib in treating severe checkpoint inhibitor pneumonitis, a serious lung inflammation caused by cancer immunotherapy. It is a multicenter randomized controlled trial that aims to provide insights into the best management strategies for this condition. Participants will be monitored for clinical outcomes and potential side effects associated with the treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of malignancy who have developed grade 3 or 4 checkpoint inhibitor pneumonitis.

Not a fit: Patients with a life expectancy of less than 12 weeks or those with uncontrolled infections or malignancy progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from severe lung inflammation due to cancer therapies.

How similar studies have performed: While the combination of corticosteroids and Ruxolitinib is a novel approach, similar studies have shown promise in managing severe immune-related adverse events.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Department of Respiratory Medicine, Peking Union Medical College Hospita — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yan Xu

Conditions Severe Checkpoint Inhibitor Pneumonitis