Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Response Rate
研究概览
简要总结
Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
- •At least 1 measurable lesion according to RECIST criteria
- •ECOG performance score 0 or 1
- •Age between 18 and 70 years
排除标准
- •Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
- •History of haemoptysis
- •Evidence of tumour invading major blood vessels on imaging.
- •Previous neoadjuvant/adjuvant chemotherapy.
- •Previous radiotherapy.
- •Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
- •Major surgical procedures within 4 weeks prior to study entry.
- •Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
- •Non-healing wound, active peptic ulcer or bone fracture.
- •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
结局指标
主要结局
Response Rate
时间窗: 4 years
The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
次要结局
- Progression free survival(5 years)
- Overall survival(5 years)
- Duration of response(5 years)