About this trial
This multicenter observational study will evaluate the safety and effectiveness of immune checkpoint inhibitor rechallenge in adults with lung cancer who developed checkpoint inhibitor pneumonitis.
The study will use both retrospective medical records and prospective follow-up data. Participants will not be assigned to any treatment by the study protocol. All treatment decisions will be made by the treating physicians as part of routine clinical care.
Participants will be classified into three groups according to their subsequent treatment: rechallenge with a PD-L1 inhibitor, rechallenge with a PD-1 inhibitor, or no immune checkpoint inhibitor rechallenge. The primary outcome is the recurrence of checkpoint inhibitor pneumonitis after rechallenge. Secondary outcomes include immune-related adverse events, progression-free survival, overall survival, objective response rate, and disease control rate at 24 weeks.
Approximately 150 participants will be included across multiple study centers in China.
Eligibility criteria
Qualifiers
Age 18 years or older.
Histologically confirmed lung cancer.
Development of checkpoint inhibitor pneumonitis after treatment with immune checkpoint inhibitor.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Disqualifiers
Incomplete clinical information required for the study analyses.
Considered unsuitable for participation by the investigator.
Trial design
Treatments tested in this trial
- PD-L1 Inhibitor Rechallenge
- PD-1 Inhibitor Rechallenge
- No Immune Checkpoint Inhibitor Rechallenge
Treatment groups
Sponsors and collaborators
Nanfang Hospital, Southern Medical University
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Shenzhen People's Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator