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临床试验/EUCTR2014-003731-20-IT
EUCTR2014-003731-20-IT进行中(未招募)1 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 - NA

OVARTIS FARMA S.P.A.0 个研究点目标入组 64 人开始时间: 2015年5月18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
64

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

  • Advanced metastatic and/or unresectable NSCLC
  • Measurable disease as determined by RECIST version 1.1
  • ECOG performance =2
  • Patients in Group 1: confirmed T790M EGFR mutation
  • Patients in Group 2: confirmed c-MET positive
  • Other inclusion criteria may apply as per protocol
  • 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 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • For Group 1: Patients who have received more than one prior line of EGFR TKI therapy
  • For Group 2: Previous treatment with a c-MET inhibitor or HGFtargeting therapy
  • Prior treatment with PD1/PD-L1 targeting therapies
  • Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy
  • Patients with interstitial lung disease
  • Patients with any active or history of autoimmune disease
  • Other exclusion criteria may apply as per protocol

研究者

发起方
OVARTIS FARMA S.P.A.

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