PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
About this study
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.
- Condition
- Lung Cancer, Rechallenge, Checkpoint Inhibitor Pneumonitis
- Tested
- PD-L1 Inhibitor Rechallenge, PD-1 Inhibitor Rechallenge, No Immune Checkpoint Inhibitor Rechallenge
- Sponsor
- Nanfang Hospital, Southern Medical University
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Lung Cancer, Rechallenge, Checkpoint Inhibitor Pneumonitis
- 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.
- Provision of written informed consent.
Exclusion 2
- Incomplete clinical information required for the study analyses.
- Considered unsuitable for participation by the investigator.
Where
5 sites, 5 recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Contact
-
Laiyu Liu
+86 13632102245 liulaiyu@sina.com
Potential match only. Final eligibility is determined by the study team.