NCT03634059Unknown不适用
A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月15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
- 80
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR 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
- •Age:18 to 75 years old (man or female);
- •Pathologically diagnosed with non-squamous NSCLC;
- •Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
- •Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);
- •None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;
- •At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Major organ function has to meet the following criteria:
- •ANC≥1.5×109/L；
- •PLT≥80×109/L；
- •ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;
- •TBIL≤1.5ULN;
- •Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate>45 ml/min;
- •Life expectancy greater than or equal to 3 months;
- •Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- •Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
排除标准
- •Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- •Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
- •Radiologically documented evidence of major blood vessel invasion or encasement by cancer;
- •A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- •Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;
- •Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
- •Patients with pregnant or planning a pregnancy;
- •Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •Less than 4 weeks from the last clinical trial;
- •The researchers think inappropriate.
研究组 & 干预措施
apatinib
Experimental
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: evaluated in two years since the treatment began
Baseline to measured date of progression or death from any cause
次要结局
- Objective response rate(tumor assessment every 8 weeks，up to two years)
- Adverse events(evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0)
- Overall survival (OS)(the first day of treatment to death or last survival confirm date，up to two years)
- Disease control rate (DCR)(tumor assessment every 8 weeks，up to two years)
研究者
LiuJunFeng
Principal Investigator
Hebei Medical University Fourth Hospital
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer PatientsEGFR Gene MutationEGFR-TKI Resistant MutationNon-small Cell Lung CancerNCT06071013China Medical University Hospital20
Unknown
1 期
Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung CancerNonsmall Cell Lung CancerNCT03050411Peking University Third Hospital30
尚未招募
2 期
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI ResistanceNon-small Cell Lung CancerNCT06634667Hunan Province Tumor Hospital30
Unknown
2 期
EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLCEGFR Gene MutationNCT03720873Fujian Cancer Hospital90
招募中
2 期
Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR MutationsNSCLCNCT06062823National University Hospital, Singapore35