NCT05991206招募中不适用
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年12月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MPR Rate
研究概览
简要总结
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must be ≥18 years.
- •Provision of fully informed consent prior to any study specific procedures.
- •Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter < 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification.
- •According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
排除标准
- •Exclusion Criteria:
结局指标
主要结局
MPR Rate
时间窗: 2 years
Neoadjuvant therapy-induced tumor regression in pathologically residual tumors \<10%
次要结局
未报告次要终点
研究者
Yongchang Zhang
Professor, Deputy Director of Thoracic Oncology Department
Hunan Province Tumor Hospital
研究点 (1)
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