NL-OMON44688已完成2 期
A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C) - CEGF816X2201C
ovartis Pharma B.V.0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
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
- •* Female and male patients * 18 years of age.
- •* Advanced metastatic and/or unresectable NSCLC.
- •* Measurable disease.
- •* Group 1: confirmed T790M EGFR mutation.
- •* Group 2: confirmed c-MET positive.
- •* ECOG performance status 0, 1, 2.
排除标准
- •* Group 1: More than one prior line of EGFR TKI therapy.
- •* Group 2: Previous treatment with a c-MET inhibitor or HGFtargeting therapy.
- •* Prior treatment with PD1/PD-L1 targeting therapies.
- •* Patients who require emergent use of systemic steroids, emergent surgery and/or radiotherapy.
- •* Interstitial lung disease.
- •* Any active or history of autoimmune disease, hepatitis B virus or hepatitis C virus
- •* Prohibited co-medication: see protocol page 46.
- •* Pregnancy, lactation, inadequate contraception (males and females). See protocol page 30-31 for details.
- •* Group 2: GI impariment resulting in altered absorption of INC280
研究者
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