Restarting immunotherapy after lung inflammation in people with lung cancer
Looks at safety of restarting immunotherapy in lung cancer patients after pneumonitis.
Key facts
- Who runs it
- Nanfang Hospital, Southern Medical University
- Where
- Guangzhou, Nanchang, Shenzhen, and Wenzhou, ChinaSee the 5 sites
- Trial code
- Registry title
- PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 20 Oct 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Observational, 3 groups
- Treatments tested
- PD-L1 Inhibitor Rechallenge
- PD-1 Inhibitor Rechallenge
- No Immune Checkpoint Inhibitor Rechallenge
- Record updated
- 20 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer who developed pneumonitis (lung inflammation) after immune checkpoint inhibitor treatment. It follows what happens afterwards, with treatment decided by their own doctors.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Lung cancer confirmed by tissue examination. Performance status (daily activity level) of 0, 1, or 2.
- Earlier treatment
- Must have had an immune checkpoint inhibitor and then developed checkpoint inhibitor pneumonitis.
Main reasons for not taking part
- Incomplete clinical information needed for the study analyses
- The investigator considers the person unsuitable for the study
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Incomplete clinical information required for the study analyses
- Considered unsuitable for participation by the investigator
Where in China
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Laiyu LiuTaking people
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Cchengzhi ZhouTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Xinyi ZhangTaking people
- Shenzhen People's HospitalShenzhen, ChinaContact: Di WuTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Xiaoying HuangTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- 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.
Treatment: PD-L1 Inhibitor Rechallenge
- 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.
Treatment: PD-1 Inhibitor Rechallenge
- 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.
Treatment: No Immune Checkpoint Inhibitor Rechallenge
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Restarting immunotherapy after lung inflammation in people with lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 August 2026