Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Incomplete clinical information required for the study analyses.
- Considered unsuitable for participation by the investigator.
