A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 3-year Disease-Free Survival
研究概览
简要总结
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
详细描述
Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.
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
- •Written informed consent provided.
- •Males or females, Aged 18-75 years.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- •EGFR activating mutation in exon 19 or
- •Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
- •ECOG performance status of 0-
- •Had a life expectancy of 12 weeks or more.
- •Adequate hematological function, adequate liver function and renal function.
- •Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
排除标准
- •Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- •Inability to comply with protocol or study procedures.
- •Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
- •Any evidence confirmed tumor recurrence before investigational therapy.
- •Known severe hypersensitivity to icotinib or any of the excipients of this product.
- •Evidence of clinically active interstitial lung disease.
- •Eye inflammation not fully controlled or conditions predisposing the subject to this.
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Known human immunodeficiency virus (HIV) infection.
- •Pregnancy or breast-feeding women.
- •Ingredients mixed with small cell lung cancer patients.
- •History of neurologic or psychiatric disorders.
研究组 & 干预措施
Intervention group
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
干预措施: Icotinib (Drug)
结局指标
主要结局
3-year Disease-Free Survival
时间窗: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
次要结局
未报告次要终点
研究者
Si-Yu Wang
Professor
Sun Yat-sen University