EUCTR2010-018945-72-BE进行中（未招募）1 期
A randomized, multicenter, open-label phase Ib/II study of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed versus cisplatin and gemcitabine/pemetrexed in patients with advanced or recurrent non small cell lung cancer who have not received prior chemotherapy
F.Hoffmann-La Roche0 个研究点目标入组 160 人开始时间: 2010年7月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •- adult patients, >/=18 years of age
- •- advanced, metastatic or recurrent non-small cell lung cancer
- •- at least 1 measurable disease lesion as per RECIST criteria
- •- confirmed presence of EGFR in tumor tissue
- •- ECOG performance status 0-1
- •- adequate hematological, renal and liver function
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •- prior chemotherapy or treatment with another systemic anti-cancer agent
- •- radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
- •- history or clinical evidence of CNS metastases
- •- recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
研究者
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