EUCTR2015-004104-33-GR进行中（未招募）1 期
A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients with Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer in Combination of Paclitaxel and Carboplatin - AVANA
Centus Biotherapeutics Limited0 个研究点目标入组 731 人开始时间: 2016年8月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 731
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients aged 18 years or older
- •Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
- •Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
- •Existence of at least 1 measurable lesion by response evaluation criteria
- •Adequate haematological, renal and liver function
- •Other inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumours and mixed adenosquamous carcinomas of predominantly squamous nature
- •Any unresolved toxicities from prior systemic therapy
- •Known sensitising EGFR mutations or EML4-ALK translocation positive mutations
- •Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
- •Known hypersensitivity to active ingredients or any excipients of the IPs and combination chemotherapy
- •Use of prohibited concomitant medication
- •Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
- •Fertile men or women of childbearing potential not using adequate contraception
- •Other exclusion criteria may apply.
研究者
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