NCT02125240Unknown3 期
Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 124
- 试验地点
- 11
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
详细描述
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Primary Outcome Measure:
Disease-free survival between Icotinib group and placebo group.
Secondary Outcome Measures:
Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically confirmed lung adenocarcinoma after surgical resection
- •Stage II-IIIA disease according to 7th edition of TNM staging
- •Patients must harbor sensitive EGFR gene mutation (19/21)
- •Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy
排除标准
- •Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
- •Presence of metastatic disease
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any unresolved chronic toxicity from previous anticancer therapy
- •Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
研究组 & 干预措施
Placebo
Active Comparator
1 tablet three times daily by mouth
干预措施: Placebo (Drug)
Icotinib
Experimental
125 mg three times daily (375 mg per day) by mouth
干预措施: Icotinib (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 36 months
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
次要结局
- Overall survival(60 months)
- Lung cancer symptoms and health-related quality of life (HRQoL) differences(60 months)
- Number of participants with adverse events(36 months)
研究者
研究点 (11)
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进行中（未招募）
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A study evaluating safety and efficacy of Itacitinib or Placebo in combination with corticosteroids as initial treatment of chronic graft versus-host diseaseEUCTR2018-001606-29-FRIncyte Corporation266