EUCTR2012-003214-13-DE进行中（未招募）1 期
A Randomized, Multicenter, Open-Label, Phase 2 Study ofPaclitaxel-Carboplatin Chemotherapy Plus Necitumumab(IMC-11F8) Versus Paclitaxel-Carboplatin ChemotherapyAlone in the First-Line Treatment of Patients WithStage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
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
- •Histologically or cytologically confirmed squamous NSCLC
- •Stage IV disease at time of study entry based on AJCC 7th edition
- •Measurable disease at time of study entry as defined by RECIST 1.1
- •Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue
- •block) available for analysis of EGFR protein expression by IHC and other biomarker assessments.
- •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 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Nonsquamous NSCLC
- •Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies
- •targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- •Previous chemotherapy for NSCLC
- •Major surgery or received any investigational therapy in the 4 weeks prior to randomization
- •Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions,
- •which is allowed)
- •Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
- •(patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic
- •and no longer require treatment with steroids or anticonvulsants, are eligible)
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