Efficacy and Safety of PD-L1 Inhibitor Rechallenge After Immune Checkpoint Inhibitor-Related Pneumonitis in Patients With Lung Cancer: A Multicenter Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Recurrence Rate of Checkpoint Inhibitor Pneumonitis After Immune Checkpoint Inhibitor Rechallenge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Provision of written informed consent.
排除标准
- •Incomplete clinical information required for the study analyses.
- •Considered unsuitable for participation by the investigator.
研究组 & 干预措施
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.
干预措施: PD-L1 Inhibitor Rechallenge (Drug)
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.
干预措施: PD-1 Inhibitor Rechallenge (Drug)
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.
干预措施: No Immune Checkpoint Inhibitor Rechallenge (Drug)
结局指标
主要结局
Recurrence Rate of Checkpoint Inhibitor Pneumonitis After Immune Checkpoint Inhibitor Rechallenge
时间窗: 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.
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.
次要结局
- Recurrence or New Onset of Other Immune-Related Adverse Events After Rechallenge(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 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 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(Up to 24 weeks after initiation of the post-pneumonitis treatment strategy)
- Disease Control Rate at 24 Weeks(Up to 24 weeks after initiation of the post-pneumonitis treatment strategy)