PD-L1 Inhibitor Rechallenge After Immunotherapy-Related Pneumonitis in Patients With Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Incomplete clinical information required for the study analyses.
Considered unsuitable for participation by the investigator.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
PD-L1 Inhibitor Rechallenge
DrugRestarting 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 Rechallenge
DrugRestarting 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 Rechallenge
DrugParticipants do not restart PD-1 or PD-L1 inhibitor therapy after checkpoint inhibitor pneumonitis. Subsequent antitumor management follows routine clinical practice.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: PD-L1 Inhibitor Rechallenge Cohort1 intervention
Group B: PD-1 Inhibitor Rechallenge Cohort1 intervention
Group C: No Immune Checkpoint Inhibitor Rechallenge Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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
1
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.
Time frame
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.2
Progression-Free Survival
From the prespecified index date until tumor progression, death, or study completion, whichever occurs first
Time frame
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.3
Overall Survival
From the prespecified index date until death or study completion, whichever occurs first
Time frame
From the date of initiation of the initial immunotherapy until death, or study completion, whichever occurs first, assessed for up to 8 years.4
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.
Time frame
Up to 24 weeks after initiation of the post-pneumonitis treatment strategySponsors and contacts
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Nanfang Hospital, Southern Medical University
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Shenzhen People's Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Source ClinicalTrials.gov