NL-OMON47910已完成2 期
BRF113928: A Phase II study of the BRAF inhibitor dabrafenib as a single agent and in combination with the MEK inhibitor trametinib in subjects with BRAF V600E mutation positive metastatic (stage IV) non-small cell lung cancer - BRF113928
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Histologically or cytologically confirmed NDCLC stage IV.
- •* Documented disease progression (primary study cohort). Subjects in Cohort C
- •required to have not received prior systemic anti-cancer therapies for
- •metastatic disease
- •* Measurable disease.
- •* 18 years and above.
- •* Life expectancy at least 3 months.
- •* ECOG performance status 0-2.
- •* Presence of a V600E BRAF mutation in lung cancer tissue.
- •* Females of childbearing potential: adequate method of contraception.
排除标准
- •* Previous treatment with a BRAF or MEK inhibitor.
- •* Anti-Cancer therapy including chemotherapy, radiation-therapy, immunotherapy,
- •biologic therapy or major surgery within 14 days prior to start of study
- •* Active GI disease or other condition that will interfere significantly with
- •the absorption of drugs.
- •* Brain metastases (exceptions see protocol page 30)
- •* A history or evidence of cardiovascular risk (see protocol page 30 for
- •* Pregnancy or breastfeeding
研究者
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