Phase III Study of Icotinib With Concurrent Radiotherapy as First-line Treatment for Unresectable/Oligometastasis NSCLC With EGFR Activating Mutation: a Prospective, Multicentre, Open-label, Randomised Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 330
- 主要终点
- Progression-free survival
研究概览
简要总结
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.
详细描述
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy. The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years
- •Pathologically documented NSCLC
- •Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI
- •Positive EGFR mutation confirmed by ARMS
- •At least 3-month life expectancy
- •Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L
- •Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN
- •Written informed consent before patient registration and any protocol-related procedures
排除标准
- •Previous radiotherapy
- •Received other investigational systemic drugs within 4 weeks prior to study entry
- •Severe or uncontrolled systemic disease
- •Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant
- •Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
- •Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
研究组 & 干预措施
icotinib plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
干预措施: icotinib (Drug)
icotinib plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
干预措施: Radiotherapy (Radiation)
icotinib
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.
干预措施: icotinib (Drug)
chemotherapy plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
干预措施: Chemotherapy (Drug)
chemotherapy plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
Incidence of radiation injure of the lungs
时间窗: 2 years
Measured according to NCI CTCAE v4.0
次要结局
- Overall survival(5 years)
- Quality of life(2 years)
- Tumor response after icotinib induction(8 weeks)
研究者
Zhen-zhou Yang
Director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University