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PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer

Recruitingn/aAges 18 Years - anyAllNanfang Hospital, Southern Medical University
NCT07775820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 years or older. 2. Histologically confirmed lung cancer. 3. Development of checkpoint inhibitor pneumonitis after treatment with immune checkpoint inhibitor. 4. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 5. Provision of written informed consent. Exclusion Criteria: 1. Incomplete clinical information required for the study analyses. 2. Considered unsuitable for participation by the investigator.
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What it tests

  • PD-L1 Inhibitor Rechallenge
  • PD-1 Inhibitor Rechallenge
  • No Immune Checkpoint Inhibitor Rechallenge
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Where

5 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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