Lung CancerNCT07775820
PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
An observational study of Lung Cancer and Rechallenge, run by Nanfang Hospital, Southern Medical University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Rechallenge, Checkpoint Inhibitor Pneumonitis
- What is being tested?
- PD-L1 Inhibitor Rechallenge, PD-1 Inhibitor Rechallenge and No Immune Checkpoint Inhibitor Rechallenge
- How many people
- 150 participants
- Where
- 5 sitesChina
- Study dates
- 20 Oct 2025to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults with histologically confirmed lung cancer who were treated with immune checkpoint inhibitor and subsequently developed checkpoint inhibitor pneumonitis. Eligible participants will be identified from participating centers in China and classified according to subsequent routine clinical management: PD-L1 inhibitor rechallenge, PD-1 inhibitor rechallenge, or no immune checkpoint inhibitor rechallenge. Both retrospective clinical records and prospective follow-up information will be collected.
Who may be able to join
- 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 join
- Incomplete clinical information required for the study analyses.
- Considered unsuitable for participation by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510030
Cchengzhi Zhou, +86 18028045334, doctorzcz@163.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510400
Laiyu Liu, +86 13632102245, liulaiyu@sina.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
Xinyi Zhang, +86 791 8631 1242, zhangxinyi80@163.com
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Di Wu, +86 136 6258 9160, wudi315817@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325088
Xiaoying Huang, +86 577 55579272, zjwzhxy@126.com
About this study
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
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.
Read more
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.
Read the detailed description
Checkpoint inhibitor pneumonitis is an important immune-related adverse event associated with immune checkpoint inhibitor treatment. Some patients with lung cancer may require immune checkpoint inhibitor rechallenge after recovery from pneumonitis because of tumor progression or limited subsequent treatment options. However, evidence regarding the safety and effectiveness of PD-L1 inhibitor rechallenge after checkpoint inhibitor pneumonitis remains limited.
This is a multicenter, ambispective, observational cohort study. The time perspective is classified as Other because the study combines retrospective review of existing medical records with prospective follow-up according to routine clinical visits.
Adults with histologically confirmed lung cancer who developed checkpoint inhibitor pneumonitis will be included. Participants will be classified into three cohorts according to routine clinical treatment decisions:
- PD-L1 inhibitor rechallenge cohort;
- PD-1 inhibitor rechallenge cohort; and
- No immune checkpoint inhibitor rechallenge cohort.
No participant will be randomly assigned to treatment, and the study protocol will not require any specific treatment, additional visit, laboratory test, or imaging examination. Treatment decisions will be made independently by the treating physicians.
Clinical information will be obtained from routine medical records and follow-up assessments. Data collected will include demographic characteristics, lung cancer characteristics, previous cancer treatment, initial checkpoint inhibitor treatment, characteristics and management of checkpoint inhibitor pneumonitis, subsequent antitumor treatment, immune-related adverse events, tumor response, disease progression, and survival.
The primary objective is to compare the recurrence of checkpoint inhibitor pneumonitis after PD-L1 inhibitor and PD-1 inhibitor rechallenge. Secondary objectives include comparisons of progression-free survival, overall survival, recurrence or new onset of other immune-related adverse events, objective response rate, and disease control rate. Exploratory analyses will evaluate clinical factors associated with the safety and effectiveness of PD-L1 inhibitor rechallenge.
A non-probability sampling approach will be used to include eligible cases available at the participating centers. The planned enrollment is 150 participants, with approximately 50 participants in each cohort.
- Conditions
- Lung Cancer, Rechallenge, Checkpoint Inhibitor Pneumonitis
- Being tested
- PD-L1 Inhibitor Rechallenge, PD-1 Inhibitor Rechallenge, No Immune Checkpoint Inhibitor Rechallenge
- Keywords
- Immune Checkpoint Inhibitor, PD-L1 Inhibitor, PD-1 Inhibitor, Immune Checkpoint Inhibitor Rechallenge, Checkpoint Inhibitor Pneumonitis, Immune-Related Adverse Events, Real-World Study
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 Inhibitor RechallengeDrug
Restarting immune checkpoint inhibitor treatment with a PD-L1 inhibitor after checkpoint inhibitor pneumonitis has improved and immunotherapy has been interrupted because of pneumonitis. The treatment is selected by the treating physician and is not assigned by the study protocol.
PD-1 Inhibitor RechallengeDrug
Restarting immune checkpoint inhibitor treatment with a PD-1 inhibitor after checkpoint inhibitor pneumonitis has improved and immunotherapy has been interrupted because of pneumonitis. The treatment is selected by the treating physician and is not assigned by the study protocol.
No Immune Checkpoint Inhibitor RechallengeDrug
Participants do not restart PD-1 or PD-L1 inhibitor therapy after checkpoint inhibitor pneumonitis. Subsequent antitumor management follows routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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. Receives: Drug: 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. Receives: Drug: No Immune Checkpoint Inhibitor Rechallenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate of Checkpoint Inhibitor Pneumonitis After Immune Checkpoint Inhibitor Rechallenge
The percentage of participants in the PD-L1 inhibitor rechallenge cohort and the PD-1 inhibitor rechallenge cohort who experience recurrent checkpoint inhibitor pneumonitis after restarting immune checkpoint inhibitor treatment. Recurrence will be determined according to the diagnosis documented by the treating physicians in the medical records.
Measured: From the date of immune checkpoint inhibitor rechallenge to the first documented CIP recurrence, death, or study completion, whichever occurs first, assessed for up to 5 years.
Secondary outcomes (5)
Recurrence or New Onset of Other Immune-Related Adverse Events After Rechallenge
The percentage of participants in the PD-L1 inhibitor and PD-1 inhibitor rechallenge cohorts who experience recurrence of a previous other immune-related adverse event or development of a new other immune-related adverse event after rechallenge, as documented in the medical records.
Measured: From the date of immune checkpoint inhibitor rechallenge to the first documented recurrence of another immune-related adverse event, death, or study completion, whichever occurs first, assessed for up to 5 years.
Progression-Free Survival
From the prespecified index date until tumor progression, death, or study completion, whichever occurs first
Measured: From the date of initiation of the initial immunotherapy until tumor progression, death, or study completion, whichever occurs first, assessed for up to 8 years.
Overall Survival
From the prespecified index date until death or study completion, whichever occurs first
Measured: From the date of initiation of the initial immunotherapy until death, or study completion, whichever occurs first, assessed for up to 8 years.
Objective Response Rate at 24 Weeks
The percentage of participants who achieve a best overall response of complete response or partial response within 24 weeks after initiation of the post-pneumonitis treatment strategy, based on routine clinical tumor response assessments documented in the medical records.
Measured: Up to 24 weeks after initiation of the post-pneumonitis treatment strategy
Disease Control Rate at 24 Weeks
The percentage of participants who achieve a best overall response of complete response, partial response, or stable disease within 24 weeks after initiation of the post-pneumonitis treatment strategy, based on routine clinical tumor response assessments documented in the medical records.
Measured: Up to 24 weeks after initiation of the post-pneumonitis treatment strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Nanchang University, Shenzhen People's Hospital, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775820
- Sponsor's protocol ID
- NFEC-2025-586
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study uses multicenter medical-record data that are subject to participant privacy requirements, institutional data-governance policies, and applicable regulations.