EUCTR2014-002565-30-FR进行中（未招募）不适用
A Randomized, Open-Label, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
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
- •- Subject must be = 18 years of age. Life expectancy > 12 weeks.
- •- Subject must have cytologically or histologically confirmed non-squamous NSCLC and are current or former smokers.
- •- Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
- •- Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1).
- •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 173
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 352
排除标准
- •- Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
- •- Subject has a known hypersensitivity to platinum compounds.
- •- Subject has peripheral neuropathy = grade 2.
- •- Subject has squamous NSCLC, or an untreated known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement.
- •- Subject has received prior cytotoxic chemotherapy for metastatic NSCLC.
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