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A randomized controlled, open-label, phase II study aimed to evaluate the efficacy and safety of topical or systemic glucocorticoid therapy for grade 2 immune-related pneumonitis

A randomized controlled, open-label, phase II study aimed to evaluate the efficacy and safety of topical or systemic glucocorticoid therapy for grade 2 immune-related pneumonitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037658
Enrollment
Unknown
Registered
2020-08-29
Start date
2020-10-30
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

topical therapy group:Inhalation budesonide 2mg 3 times per day
systemic glucocorticoid therapy group:intravenous methylprednisolone 1~2mg/kg

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. ECOG score 0-3; 3. Histologically or cytologically confirmed lung cancer,including non-small cell lung cancer and small cell lung cancer; 4. Recieving anti-PD-1/PD-L1 therapy; 5. Grade 2 of ICI-related penumonitis occured; 6. Patients must join the study voluntarily.They should be cooperate with examination,treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. Have recieved systemic glucocorticoid treatment; 2. Allergic to adrenocorticosteroids; 3. Existed contraindication of glucocorticoid treatment, estimate by researchers; 4. Medical history, disease, treatment or abnormal laboratory results that may interfere with the results and prevent patients from participating in this study. Or the researchers think that it is not in the best interests of patients to participate in this study; 5. The investigators believe that it is not suitable for inclusion

Design outcomes

Primary

MeasureTime frame
treatment response rate;immunotherapy suspended time;

Secondary

MeasureTime frame
time to recover;immunotherapy re-challenge rate;

Countries

China

Contacts

Public ContactJing Zhao

Shanghai Pulmonary Hospital

zhaojing626@163.com+86 21-65115006-3062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026