Can a targeted drug tame Immunotherapy's most dangerous side effect?
NCT ID NCT05899725
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial investigates whether adding the drug ruxolitinib to standard corticosteroids can better treat severe checkpoint inhibitor pneumonitis (CIP) — a serious lung inflammation that can occur in cancer patients receiving immunotherapy. About 60 adults with grade 3 or 4 CIP will be randomly assigned to receive either corticosteroids alone or corticosteroids plus ruxolitinib. The goal is to see if the combination allows faster tapering of steroids and improves recovery without increasing harm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- corticosteroids and ruxolitinib
- What this could lead to
- If adding ruxolitinib works, it could offer a faster, safer way to control severe lung inflammation from immunotherapy, reducing steroid use and side effects.
- What could go wrong
- This is an early-stage trial with only 60 participants, so results may not apply broadly. Ruxolitinib also carries risks like infection and blood cell changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Respiratory Medicine, Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730, China
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Shanxi Bethune Hospital
Taiyuan, Shanxi, China
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The Affiliated hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
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The second affiliated hospital of Nanchang University
Nanchang, Jiangxi, China