A Multicenter Phase II Trial of Pemetrexed Plus Carboplatin With or Without Apatinib in Patients With Advanced Non-small Cell Lung Cancer Without EGFR Mutation, ALK Gene Rearrangement, and ROS1 Gene Rearrangement
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.
详细描述
Platinum-based chemotherapy is the recommended therapeutic approach for patients with advanced non-small cell lung cancer (NSCLC) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement. However, the prognosis of advanced NSCLC remains poor. Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2. Apatinib has been proved to be effective and safe in heavily pretreated patients with gastric cancer. This study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.
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
- •Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement.
- •Written informed consent provided.
- •Male and female patients aged ≥18 years, < 75 years.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy ≥12 weeks.
- •Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- •Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- •Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- •Female subjects should not be pregnant or breast-feeding.
排除标准
- •Known severe hypersensitivity to apatinib or any of the excipients of this product.
- •Inability to comply with protocol or study procedures.
- •A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- •A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- •Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
- •Patients with prior radiotherapy
- •History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- •Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- •Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
研究组 & 干预措施
Apatinib
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
干预措施: Apatinib (Drug)
Apatinib
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
干预措施: Pemetrexed (Drug)
Apatinib
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
干预措施: Carboplatin (Drug)
Control
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
干预措施: Pemetrexed (Drug)
Control
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year after the last patient is randomized
Overall survival was assessed from randomization to death as a result of any cause.
次要结局
- Disease-free survival(1 year after the last patient is randomized)
- Number of Participants with Adverse Events(1 year)
研究者
Si-Yu Wang
Professor
Sun Yat-sen University