Evaluation of Inhaled Budesonide to Prevent Recurrence and Support Treatment of Checkpoint Inhibitor Pneumonitis in Adults with Solid Tumors

What this Trial Is About

Researchers are investigating the use of inhaled steroids to prevent the recurrence of checkpoint inhibitor pneumonitis CIP, a serious lung inflammation that can occur in cancer patients treated with immune checkpoint inhibitors. These immunotherapy drugs help the immune system attack cancer cells but can sometimes cause the immune system to attack healthy lung tissue, leading to CIP. This trial aims to assess whether inhaled budesonide can help resolve lung inflammation and reduce its return, improving quality of life and cancer treatment decisions for patients with solid tumors. Participants will be randomly assigned to one of two groups. One group will receive usual care, which includes systemic steroids orally or intravenously based on the severity of CIP. The other group will receive inhaled budesonide twice daily using a Turbuhaler device for 36 weeks alongside usual care. CIP flare-ups during the study will be managed as initial episodes according to guidelines. The study is designed as a phase 2 randomized trial comparing these approaches. During the study, participants will be monitored for the development of refractory or recurrent CIP over one year. Researchers will assess steroid-related side effects, systemic steroid use, time to improvement of initial CIP, and patient-reported outcomes. Participants need to be able to use the inhaler device or have caregiver support. The trial involves regular assessments over the 36-week treatment period and follow-up to measure lung inflammation control and treatment impact.

Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis