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

SCS Boehringer Ingelheim Comm. V0 个研究点目标入组 1,100 人开始时间: 2010年2月3日最近更新: 2016年3月14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 recieved and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s))for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
•3. Patients pretreated with taxane-based chemotherapy for advanced or metatstatic disease must have experienced stable disease, partial or complete response as best response
•1. Clinical benefit of 12 weeks duration in Part A
•2. Patients must have progressed in Part A according to RECIST 1.1
•3. New informed consent must be signed before patients enter Part B of the trial
•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 595
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 374

•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%
•23. Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1.

发起方

SCS Boehringer Ingelheim Comm. V