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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05899725
- Acronym / sponsor ID
- K22C2678
- Conditions
- Severe Checkpoint Inhibitor Pneumonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Inner Mongolia Medical University, Shanxi Bethune Hospital
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: severe CIP with the treatment of corticosteroids | Active comparator | Drug: Corticosteroidssevere CIP with the treatment of corticosteroids |
| Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib | Experimental | Drug: Corticosteroids and Ruxolitinibsevere CIP with the treatment of corticosteroids and Ruxolitinib |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidsInitial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence | Drug | Cohort 1: severe CIP with the treatment of corticosteroids |
| Corticosteroids and RuxolitinibInitial 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 | Drug | Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib |
Primary outcome
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.
5 secondary outcomes
Mortality
Time frame: 8 weeks
Proportion of invasive ventilator assisted respiration
Time frame: 8 weeks
Incidence of pulmonary infection
Time frame: 8 weeks
Total corticosteroids usage
Time frame: 8 weeks.
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG
Time frame: 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.