EUCTR2009-014563-39-GB进行中（未招募）1 期
Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator’s choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment - LuxLung 5
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,302
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
入选标准
- •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 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 availablility 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 metastatic disease must have experienced stable disease, partial or complete response as best response.
- •4. Eastern Cooperative Oncology Group (ECOG) performace score 0-2.
- •5. Patients with at least one tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in least one dimension with longest diameter to be recorded as >= 10mm but no less than double the slice thickness according to RECIST 1.1
- •1. Clinical benefit of 12 weeks duration in Part A of the trial determined on the second tumour assessment
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous treatment with BIBW 2992
- •2. Chemo-, hormone or immunotherapy within the past 4 weeks.For pretreatment with TKIs (erlotinib(Tarceva) or gefitinib (Iressa)) 2 weeks only.
- •3. Active/symptomatic brain metastases including leptomeningeal disease. Patients with a history of treated brain metastatis must have a stable or normal brain MRI/CT scan at screening and be at least 4 weeks post-radiation or surgery for brain metastasis. Dexamethasone therapy will be allowed only if administered at a stable dose for at least one month prior to randomization.
- •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 cardiovascular abnormalities
- •6. Cardiac left ventricular function with resting ejection fraction of less than 50%
- •The rest of the other points to 22 and the new point 23 have been included:
- •7) Radiotherapy within the past 2 weeks prior to treatment with the trial drug
- •8) History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) functional classification of 3, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization
- •9) Cardiac left ventricular function with resting ejection fraction of less than 50%
- •measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
- •10) Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) =400 mg/m2
- •11) Absolute neutrophil count (ANC) =1500/mm3
- •12) Platelet count =100,000/mm3
- •13) Bilirubin =1.5 mg/dL (>26 µmol/L, SI unit equivalent)
- •14) Aspartate amino transferase (AST) or alanine amino transferase (ALT) =three times the upper limit of normal (if related to liver metastases = five times the upper limit of normal)
- •15) Serum creatinine =1.5 times the upper normal limit or calculated/measured creatinine clearance =45 mL/min
- •16) Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
- •17) Pregnancy or breast feeding
- •18) Patients unable to comply with the protocol
- •19) Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
- •20) Known or suspected active drug or alcohol abuse
- •21) Pre-existing or current interstitial lung disease (ILD)
- •22) Peripheral polyneuropathy >Grade 2
- •23) Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1
研究者
相似试验
进行中（未招募）
不适用
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 treatmentPatients with NSCLC stage IIIb and IV after failure of treatment with erlotinib or gefitinibEUCTR2009-014563-39-HUBoehringer Ingelheim Pharma GmbH & Co. KG1,100
已完成
3 期
A clinical trial to study the effects of a new drug and compare the effect of BIBW 2992 along with paclitaxel and investgators choice chemotherapy in patients with Non-Small Cell Lung Cancer failing previous erlotinib or gefitinib treatmentCTRI/2010/091/001098Boehringer Ingelheim900
进行中（未招募）
不适用
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 treatmentPatients with NSCLC stage IIIb and IV after failure of treatment with erlotinib or gefitinibEUCTR2009-014563-39-BESCS Boehringer Ingelheim Comm. V1,100
进行中（未招募）
不适用
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 treatmentPatients with NSCLC stage IIIb and IV after failure of treatment with erlotinib or gefitinibEUCTR2009-014563-39-DEBoehringer Ingelheim Pharma GmbH & Co. KG1,100
进行中（未招募）
1 期
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 5Patients with NSCLC (non-small cell lung cancer) stage IIIb and IV experiencing a benefit from BIBW 2992 monotherapy after failing at least one line of chemotherapy and prior treatment with erlotinib or gefitinib.EUCTR2009-014563-39-FRBoehringer Ingelheim France900