EUCTR2009-013838-25-HU进行中（未招募）1 期
A Randomized, Multicenter, Open-Label, Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) - SQUIRE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ImClone LLC
- 入组人数
- 1,080
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
- •Stage IV disease at the time of study entry (AJCC Staging Manual, Seventh Edition)
- •Measurable or nonmeasurable disease at the time of study entry as defined by ECIST 1.0 (patients with only truly nonmeasurable disease are not eligible)
- •Archived tumor tissue (minimum of four slides) available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH).
- •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 648
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 432
排除标准
- •Key Exclusion Criteria:
- •Nonsquamous NSCLC.
- •Prior anticancer 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 (patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
研究者
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