A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
详细描述
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA 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.
- •Aged 18-75 years.
- •Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- •EGFR activating mutation in exon 19 or
- •Had completed four cycles of platinum-based adjuvant chemotherapy.
- •Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
- •ECOG performance status of 0-
- •Had a life expectancy of 12 weeks or more.
- •Adequate hematological function, adequate liver function and renal function.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •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 besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- •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
6-month icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months
干预措施: 6-month Icotinib (Drug)
12-month icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months
干预措施: 12-month icotinib (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: 5 years after the last patient is randomized
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
次要结局
- Number of Participants with Adverse Events(2 years)
- Change from baseline in patient reported Lung Cancer Functional Assessment(2 years)
- Overall Survival(5 years after the last patient is randomized)
研究者
Si-Yu Wang
Professor
Sun Yat-sen University