EUCTR2009-013838-25-GR进行中（未招募）不适用
A Randomized, Multicenter, Open-Label, Phase 3 Study of Gemcitabin-Cisplatin Chemotherapy Plus IMC-11F8 Versus Gemcitabin-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Squamous Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) - SQUIRE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ImClone LLC
- 入组人数
- 947
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
- •Key Inclusion Criteria:
- •- Histologically- or cytologically-confirmed squamous NSCLC
- •- Advanced (Stage IIIB or Stage IV) disease at the time of study entry
- •- Measurable or nonmeasurable (ie, evaluable) disease at the time of study entry as
- •defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0
- •- Tumor tissue available for analysis of EGFR gene copy number and EGFR mutation
- •status (minimum of eight slides, formalin-fixed, paraffin-embedded tissue)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key Exclusion Criteria:
- •- Nonsquamous NSCLC
- •- Prior therapy with monoclonal antibodies, signal transduction inhibitors, or any
- •therapies targeting the EGFR, VEGF, or VEGFR
- •- Previous chemotherapy for advanced NSCLC (patients who have received adjuvant
- •chemotherapy = 1 year prior to randomization are eligible)
- •- Major surgery or 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
研究者
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