An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).
详细描述
This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 18 years
- •ECOG performance status 0-1
- •Adequate haematological function, coagulation, liver function and renal function
- •Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
- •TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
- •Measurable or evaluable disease (according to RECIST 1.1 criteria).
- •Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)
排除标准
- •- Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
- •Patients with any known significant ophthalmologic anomaly of the ocular surface
- •Patients who received prior chemotherapy for metastatic disease
- •CNS metastases
- •Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
- •Pregnancy
研究组 & 干预措施
EGFR-TKIs and Anlotinib
Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d
干预措施: erlotinib or gefitinib or icotinib (Drug)
EGFR-TKIs and Anlotinib
Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
次要结局
- Overall survival(Three years)
- Objective response(through study completion,an average of three years)
- Safety - Adverse events graded according to NCI CTCAE V4.03(within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient)