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临床试验/NL-OMON44688
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

发起方
ovartis Pharma B.V.

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