NCT07775820Recruiting
PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 27 Jul 2026
- Start date
- 20 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07775820
What you commit to
- Study type: Observational
- Planned participants: 150
- From 20 Oct 2025 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Incomplete clinical information required for the study analyses.
- Considered unsuitable for participation by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.