Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Shenzhen People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Laiyu Liu
liulaiyu@sina.com
+86 13632102245
Time Frame
Start Date:2025-10-20
Estimated Completion Date:2027-06-30
Participants
Target number of participants:150
Treatments
PD-L1 Inhibitor Rechallenge Cohort
Participants with lung cancer who developed checkpoint inhibitor pneumonitis and subsequently restarted immune checkpoint inhibitor therapy with a PD-L1 inhibitor after interruption of immunotherapy because of pneumonitis. Rechallenge treatment is selected by the treating physician as part of routine clinical care and is not assigned by the study protocol.
PD-1 Inhibitor Rechallenge Cohort
Participants with lung cancer who developed checkpoint inhibitor pneumonitis and subsequently restarted immune checkpoint inhibitor therapy with a PD-1 inhibitor after interruption of immunotherapy because of pneumonitis. Rechallenge treatment is selected by the treating physician as part of routine clinical care and is not assigned by the study protocol.
No Immune Checkpoint Inhibitor Rechallenge Cohort
Participants with lung cancer who developed checkpoint inhibitor pneumonitis and did not restart PD-1 or PD-L1 inhibitor therapy. Subsequent antitumor treatment, if any, is selected by the treating physician according to routine clinical practice.
Collaborators: Shenzhen People's Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Nanchang University
Leads: Nanfang Hospital, Southern Medical University