PD-L1 Inhibitor Rechallenge After Pneumonitis in Lung Cancer
Official title: Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
Run by Nanfang Hospital, Southern Medical University · NCT07775820 · Data updated 2026-11-12
This study looks at how safe and helpful restarting PD-L1 or PD-1 inhibitors is for adults with lung cancer who previously had immune checkpoint inhibitor–related pneumonitis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07775820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with lung cancer who previously developed checkpoint inhibitor pneumonitis and are considered for rechallenge by their treating physician.
✕Probably not a fit
Patients unlikely to benefit include those with ongoing or recent pneumonitis or those not considered candidates for rechallenge by their physician.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, ambispective observational study will follow adults with histologically confirmed lung cancer who developed pneumonitis after checkpoint inhibitor therapy. Participants are grouped by real-world treatment decisions into PD-L1 inhibitor rechallenge, PD-1 inhibitor rechallenge, or no rechallenge, with no assigned interventions. Data come from retrospective medical records and prospective follow-up during routine care, focusing on recurrence of pneumonitis and other outcomes such as immune-related adverse events, progression-free survival, overall survival, and response rates at 24 weeks. No additional tests or visits are mandated by the protocol; treatment choices are made by treating physicians. The study aims to clarify safety and effectiveness of rechallenge in this context.
Why it matters
Potential benefit: If successful, the study could clarify when rechallenging with PD-L1 or PD-1 inhibitors might be safe and help guide treatment decisions after pneumonitis.
How similar studies have gone: Evidence for PD-L1/PD-1 inhibitor rechallenge after pneumonitis is limited, making this observational study relatively novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting -
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China Recruiting -
Shenzhen People's Hospital
Shenzhen, Guangdong, China Recruiting -
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting -
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Laiyu Liu
- Email: liulaiyu@sina.com
- Phone: +86 13632102245
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.