NCT02191059Unknown2 期
Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:
Shandong Cancer Hospital and Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Response Rate(ORR)
研究概览
简要总结
- There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .
- Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably, anti-tumor activities were observed in patients with advanced NSCLC.
- In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in combination with Docetaxel as second-line treatment for NSCLC patients with wild type EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall survival(OS) and health related quality of life(HRQoL) will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing after first-line chemotherapy;
- •Patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity;
- •Age: 18-70 years old;
- •Patients with wild-type EGFR;
- •With a histologically or cytologically confirmed measurable disease (longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to Response Evaluation Criteria in Solid Tumors (RECIST Criteria);
- •Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2;
- •Must have an expected survival time of at least 12 weeks;
- •Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb) ≥ 9g/dL;
- •adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases);
- •adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal;
- •No malabsorption or other gastrointestinal disorders affecting drug absorption;
- •Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.Male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment;
- •Patients have provided a signed Informed Consent Form.
排除标准
- •Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab;
- •Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort;
- •Allergic to icotinib or any of the excipients of this product.
- •Prior chemotherapy with any paclitaxel agents;
- •Central nervous system (CNS) metastases without radiotherapy and/or surgery;
- •Evidence of clinically active Interstitial lung diseases;
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases;
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ);
- •Psychiatric illness that would prevent the patient from giving informed consent;
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study;
- •Patient is concurrently using other approved or investigational antineoplastic agent;
- •Pregnant or lactating women;
- •Positive epidermal growth factor receptor mutation.
研究组 & 干预措施
Intermittent High Dose of Icotinib
Experimental
Intermittent High Dose of Icotinib in Combination With Docetaxel:
Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle
干预措施: Icotinib (Drug)
Intermittent High Dose of Icotinib
Experimental
Intermittent High Dose of Icotinib in Combination With Docetaxel:
Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Response Rate(ORR)
时间窗: 10-12 months
次要结局
- Progression Free Survival(PFS)(10-12 months)
- Overall Survival(OS)(10-12momths)
- Health Related Quality of Life(HRQoL)(10-12months)
研究者
Zhehai Wang
Vice President
Shandong Cancer Hospital and Institute
研究点 (1)
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