Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 2y DFS
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.
详细描述
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality.
OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS).
Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;
- •The gene detects EGFR mutations is positive;
- •The age is between 18-70 years;
- •Liver and kidney function and Bone marrow hematopoiesis is normal;
- •There are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition;
- •No other malignant diseases within 5 years;
- •Patients who have not received radiotherapy, systemic chemotherapy, or biological therapy;
- •Understand the whole process of the trial and voluntarily participate in and sign the informed consent form.
排除标准
- •The tumor has invaded the surrounding tissue;
- •Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;
- •Arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin Except), symptomatic coronary artery disease or myocardium. Ischemic or congestive heart failure exceeds NYHA class II;
- •severe hypertension with poor drug control;
- •moderate to severe proteinuria;
- •HIV fluHistory of infection or active chronic hepatitis B or C;
- •Malnutrition, decompensation of organ function;
- •History of chest radiotherapy;
- •Incomplete inflammation of eyes;
- •Patients with seizures that need to be treated;
- •Interstitial pneumonia;
- •Drug abuse and others that may interfere with patients' participation in the study or studyThe assessment of the results has an impact;
- •Allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test;
- •Any instability. The condition of the patient may jeopardize patient safety and compliance;
- •Pregnancy or breastfeeding women and having fertility without adequate contraception.
研究组 & 干预措施
Gefitinib therapy group
Patients are treated with Gefitinib (250 mg, orally, every day) for 56 days and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.
干预措施: Gefitinib (Drug)
Vinorelbine combination therapy group
Patients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.
干预措施: Vinorelbine (Drug)
Vinorelbine combination therapy group
Patients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.
干预措施: Carboplatin (Drug)
结局指标
主要结局
2y DFS
时间窗: 2 years
2-year disease-free survival
次要结局
- ORR(6 months)