NCT03389256Unknown2 期
A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy
Sichuan Cancer Hospital and Research Institute3 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2018年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.
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
- 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
- •Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or other local treatment);
- •Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib / gefitinib) treatment;
- •No T790M mutation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •Life expectancy of more than 3 months;
- •Adequate bone marrow function: WBC ≥ 3.0 ×10 E+9/L, neutrophil ≥ 1.5 × 10 E+9/L, platelets ≥ 80 × 10E+9/L,Hb ≥ 10.0g/dL;a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤3UNL or ≤5UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault);
- •Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug;
- •the participants volunteered to join this study should sign the informed consent forms, have better compliance in the follow-up;
排除标准
- •Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma);
- •Active brain metastases, cancerous meningitis, patients with spinal cord compression;
- •Rapid progression of the disease or cancer invades vital organs;
- •The distance between the tumor lesion and the large blood vessel is less than 5 mm, or there is a central tumor invading local macrovascular;
- •obvious pulmonary cavity or tumor necrosis;
- •Uncontrollable high blood pressure;
- •Grade Ⅱ or above myocardial ischemia or myocardial infarction or arrhythmia control is not good,Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasonography showed left ventricular ejection fraction (LVEF) <50% according to the NYHA standard;
- •Have a history of interstitial lung disease or patients with interstitial lung disease;
- •Coagulation abnormalities (INR> 1.5 or PT> ULN + 4s or APTT> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- •There was significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above;
- •A clinically significant bleeding symptom or bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above, or vasculitis that occurred within 3 months prior to enrollment;
- •Aneurysm / venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- •Arterial / venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months prior to enrollment;
- •Hereditary or acquired bleeding and thrombophilia, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism；
- •Long-term unhealed wounds or fractures;
- •Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to enrollment;
- •Unable to swallow, chronic diarrhea or intestinal obstruction;
- •Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to enrollment;
- •Urinary protein ≥ ++, 24-hour urinary protein ≥ 1.0 g;
- •Active infections require antimicrobial treatment;
- •ALK gene abnormalities (gene fusion or mutation occurred);
- •Pregnant or lactating women, or women unwilling or unable to take effective contraception;
研究组 & 干预措施
apatinib combine with EGFR-TKI
Experimental
Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
干预措施: Apatinib (Drug)
apatinib combine with EGFR-TKI
Experimental
Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
干预措施: EGFR-TKI (Drug)
EGFR-TKI
Active Comparator
Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
干预措施: EGFR-TKI (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 24 months
the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
次要结局
- Duration of response (DOR)(up to 24 months)
- Disease Control Rate (DCR)(24 weeks)
- Overall survival (OS)(up to 36 months)
- Overall response rate (ORR)(24 weeks)
- the quality of life (QoL)(up to 36 months)
研究者
Juan LI, MD
MD
Sichuan Cancer Hospital and Research Institute
研究点 (3)
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