Induction Therapy With Targeted Therapy Followed by Surgery for Stage IIIB and IV Non-small Cell Lung Cancer: a Multi-center, Single-arm, Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer.
详细描述
Advanced non-small cell lung cancer (NSCLC) accounts for a high proportion of lung cancer cases. Targeted therapy improve the survival in these patients, but acquired drug resistance will inevitably occur. If tumor downstaging is achieved after targeted therapy, could surgical resection before drug resistance improve clinical benefits for patients with advanced NSCLC? Here, the investigators conducted a clinical trial showing that for patients with advanced driver gene mutant NSCLC who did not progress after targeted therapy, salvage surgery (SS) could improve progression-free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of NSCLC with confirmed activation of driver gene mutation (EGFR mutant: exon 19 deletion or exon 21 L858R mutation; ALK-rearrangement) by amplification refractory mutation system (ARMS);
- •stage IIIB-IV according to the eighth edition of the American Joint Committee on Cancer staging system confirmed by pathological diagnosis and positron emission tomography-computed tomography (PET-CT) and biopsy
- •Written informed consent provided；
- •Age 18-70 when signing the consent form, both male and female;
- •The ECOG score is 0 or 1;
- •Adequate hematological function, liver function and renal function;
- •Female participants should not be pregnant or breast-feeding.
排除标准
- •Previously received systemic anti-tumor therapy for non-small cell lung cancer;
- •Subjects who have received chest radiotherapy in the past;
- •Known human immunodeficiency virus (HIV) infection;
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
- •Pregnancy or breast-feeding women;
- •Ingredients mixed with small cell lung cancer patients.
研究组 & 干预措施
targeted therapy+salvage surgery
Participants treated with targeted therapy without progression and radiological confirmation of tumor downstaging (≤stage IIIA) by PET-CT followed by salvage surgery were enrolled into the group of targeted therapy plus salvage surgery.
The molecular targeted agents used in our study included osimertinib (80 mg, once a day) . Salvage surgery was defined as surgical intervention based on standard operation (lobectomy plus lymphadenectomy) of NSCLC for advanced patients who initially had no surgical indications, but achieved significant downstaging (≤stage IIIA) without progression after targeted therapy.
Targeted therapy was continued after salvage surgery until progression.
干预措施: Osimertinib Mesylate (Drug)
结局指标
主要结局
PFS
时间窗: 3 year
Progression-Free Survival
次要结局
- OS(3 year)
- Resectability rate(1 year)