Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:
- What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
- How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.
详细描述
The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:
- What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?
- How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
- •Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
- •No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- •Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
- •At least one measurable lesion (RECIST v1.1).
排除标准
- •Patients included in unblinded clinical trials or anti-tumor drug intervention.
- •Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
研究组 & 干预措施
Neoadjuvant immunotherapy
Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.
干预措施: Neoadjuvant immunotherapy (Drug)
Other neoadjuvant treatment
Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.
干预措施: Other drugs for neoadjuvant treatment (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: DFS was defined as the time from surgery to the date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 years.
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Pathological Complete Response (pCR)
时间窗: Within 15 days after surgery
defined as 0% of viable tumor cells in primary tumor and lymph nodes
次要结局
- Event-free survival (EFS)(EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.)
- Relapse Patterns(Within 10 years after surgery)
- Overall survival (OS)(From date of surgery until date of death due to any cause, up to approximately 10 years.)
- Major Pathological Response (MPR)(Within 15 days after surgery)