PHASE III RANDOMIZED TRIAL OF BIBW 2992 PLUS WEEKLY PACLITAXEL VERSUS INVESTIGATOR´S CHOICE OF CHEMOTHERAPY FOLLOWING BIBW 2992 MONOTHERAPY IN NON-SMALL LUNG CANCER PATIENTS FAILING ERLOTINIB OR GEFITINIB

Boehringer Ingelheim,0 个研究点目标入组 5 人开始时间: 2010年12月1日最近更新: 2023年9月4日

试验速览

暂无简介。

•1)Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib) or gefitinib.
•2)Patients should have received 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)Eastern Cooperative Oncology Group performance Score 0 or 1.
•4)Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 10 mm but no less than double the slice thickness according to RESIST 1.1

•1)Previous treatment with BIBW 2992
•2)Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
•3)Active/symptomatic brain metastases including leptomeningeal disease. Patients with a history of treated brain metastasis must have a stable or normal brain MRT/CT scan at screening and be at least 4 weeks post-radiation or surgery for brain metastasis. Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
•4)Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn´s disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline

发起方

Boehringer Ingelheim,