NCT03766490Unknown不适用
A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年3月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- PFS（Progress free survival）
研究概览
简要总结
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.
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
- •Participants must have histlogically confirmed stage IV non-small cell lung cancer .
- •The initial treatment with gefitinib/icotinib evaluated PR/NC and the efficacy lasted for more than 6 months, then the disease progressed later. (The efficacy was assessed as PD according to the evaluation standard of RECIST1.1)
- •At least a measurable lesion that meets the RECIST 1.1 criteria.
- •Any gender. Age ≥18 years and ≤75 years
- •Life expectancy >3 months.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment.
- •Adequate organ function: haemoglobin ≥ 90 g/L;neutrophils count ≥1.5×109/L; platelet count ≥ 90 × 109/L; total bilirubin ≤ 1.5 × ULN ;ALT < 2 × ULN, (ALT < 5 × ULN, for those with liver metastases);AST < 2 × ULN, (AST < 5 × ULN, for those with liver metastases); Cr≤1.5× ULN.
- •Echocardiography : LVEF≥50%
- •12-leads electrocardiogram : QTcF<450ms (man), <470ms(woman)
- •Patient informed consent and signed written consent
- •Patient compliance was good and voluntary follow-up, treatment, laboratory testing, and other research steps were performed as planned.
排除标准
- •The patient has previously received anti-tumor therapy for EGFR TKIs other than gefitinib and ectinib for lung cancer.
- •Patients that cannot detect EGFR gene, or patients with known T790M mutation.
- •Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer).
- •CT or MRI shows that the tumor lesion is ≤ 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor.
- •Active brain metastasis, cancerous meningitis, spinal cord compression patients.
- •Other active malignancies that require simultaneous treatment.
- •Has a history of malignant tumors in the past 5 years.
- •Patients with previous anti-tumor treatment-related adverse reactions who have not recovered to NCI-CTC AE≤
- •Abnormal coagulation ,with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- •Renal insufficiency: urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g, or creatinine clearance <60ml / min.
- •Severe acute or chronic infection requiring systemic treatment.
- •Suffering from severe cardiovascular disease: myocardial ischemia ,myocardial or arrhythmia.
- •Clinically significant hemoptysis occurred within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or a clear tendency to hemorrhage.
- •Untreated active hepatitis : Hepatitis B or Hepatitis C
研究组 & 干预措施
Anlotinib Hydrochloride plus gefitinib or icotinib
Experimental
干预措施: Anlotinib Hydrochloride (Drug)
Anlotinib Hydrochloride plus gefitinib or icotinib
Experimental
干预措施: Gefitinib (Drug)
Anlotinib Hydrochloride plus gefitinib or icotinib
Experimental
干预措施: Icotinib (Drug)
结局指标
主要结局
PFS（Progress free survival）
时间窗: each 42 days up to PD or death(up to 24 months)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
次要结局
- Overall Survival (OS)(From randomization until death (up to 24 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Quality of Life(QoL)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
研究者
研究点 (1)
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