Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versusInvestigator’s choice of chemotherapy following BIBW 2992monotherapy in non-small cell lung cancer patients failing previouserlotinib or gefitinib treatment - LuxLung 5

Boehringer Ingelheim France0 个研究点目标入组 900 人开始时间: 2010年1月14日最近更新: 2016年7月4日

适应症

试验速览

暂无简介。

•1. Patients with pathologically confirmed diagnosis of NSCLC Stage IIIb and IV who failed treatment with erlotinib or gefitinib
•2. Patients should have received and failed at least one line of cytotoxic chemotherapy for advanced or metastatic disease; however, the following patients are exempt:
•a) patients with known EGFR mutation shown by accepted methods after therapy with reversible TKIs are eligible without prior chemotherapy
•b) patients with clinical benefit (disease stabilisation or response) to erlotinib or gefitinib >= 6 months are eligible without prior chemotherapy
•1. Clinical benefit of greater than 12 weeks duration in Part A
•2. Patients must have progressed in Part A according to RECIST 1.1
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Previous treatment with BIBW 2992
•2. Chemo-, hormone or immunotherapya within the past 4 weeks
•3. Active brain metastases
•4. Patients who have any other life-threatening illness or organ system dysfunction
•5. Other malignancies diagnosed requiring therapy
•6. History or presence of clinically relevant cardiovascularabnormalities
•7. Cardiac left ventricular function with resting ejection fraction of less than 50%

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