Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Overall Survival
研究概览
简要总结
The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.
- •Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.
- •Has a medical record of disease progression during the first-line treatment.
- •Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.
排除标准
- •First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.
- •Excluding patients with incomplete key baseline and treatment information.
- •Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator
研究组 & 干预措施
Observation
Patients with advanced NSCLC who have received standard first-line immune checkpoint inhibitor therapy and have experienced disease progression. Retrospective case screening and collection were conducted, and follow-up observations were carried out.
干预措施: Observation (Other)
结局指标
主要结局
Overall Survival
时间窗: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months
The overall survival time of the patients enrolled.
Progression Free Survival
时间窗: Time from 2nd line treatment initiation to the first recorded progression event in the medical information system (radiographic report or physician assessment) or death from any cause, whichever occurs first, assessed up to 60 months
The time of disease progression free survival.
次要结局
- Objective Response Rate(From 2nd line treatment initiation, assessed up to 24 months)
- Disease control rate(From 2nd line treatment initiation, assessed up to 24 months)
- Immune-related adverse events(From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months)
研究者
JIANCHUN DUAN
Chief physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences