Severe Checkpoint Inhibitor PneumonitisNCT05899725
The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia
A study testing Corticosteroids and Corticosteroids and Ruxolitinib in people with Severe Checkpoint Inhibitor Pneumonitis, run by Peking Union Medical College Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Severe Checkpoint Inhibitor Pneumonitis
- What is being tested?
- Corticosteroids and Corticosteroids and Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 14 Apr 2023to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Department of Respiratory Medicine, Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730
The Affiliated hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
The second affiliated hospital of Nanchang University
Nanchang, Jiangxi
Shanxi Bethune Hospital
Taiyuan, Shanxi
About this study
Official 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
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.
- Conditions
- Severe Checkpoint Inhibitor Pneumonitis
- Being tested
- Corticosteroids, Corticosteroids and Ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidsDrug
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
Corticosteroids and RuxolitinibDrug
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: severe CIP with the treatment of corticosteroids | Active comparator | severe CIP with the treatment of corticosteroids Receives: Drug: Corticosteroids |
| Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib | Experimental | severe CIP with the treatment of corticosteroids and Ruxolitinib Receives: Drug: Corticosteroids and Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Mortality
Mortality of severe CIP patients at 8 weeks.
Measured: 8 weeks
Proportion of invasive ventilator assisted respiration
Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Measured: 8 weeks
Incidence of pulmonary infection
Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Measured: 8 weeks
Total corticosteroids usage
Total corticosteroids usage for severe CIP patients in 8 weeks.
Measured: 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.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start14 Apr 2023
- Primary completion1 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Checkpoint Inhibitor PneumonitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Inner Mongolia Medical University, Shanxi Bethune Hospital
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899725
- Sponsor's protocol ID
- K22C2678
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided