Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation

This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft capsules, and Ganoderma spore oil) to standard glucocorticoid therapy improves outcomes in patients with Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP), compared with standard glucocorticoid therapy alone. A total of 60 patients with malignancies who develop Grade 3-4 CIP (per CTCAE v5.0) after at least one cycle of immune checkpoint inhibitor therapy will be randomized 1:1 to the experimental or control arm. The primary endpoints are time to pneumonitis downgrading and the proportion of patients achieving downgrading at 3 months.

NCT Number	NCT07554885
Lead Sponsor	Guangzhou Institute of Respiratory Disease
Conditions	Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms
Enrollment	60 participants
Start Date	2026-04
Primary Completion	2028-12 (estimated)
Study Completion	2029-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-26