PER-115-09已完成未知
A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),0 个研究点目标入组 7 人开始时间: 2009年12月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
入选标准
- •Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- •EGFR mutation detected by central laboratory analysis of tumour biopsy material.
- •Measurable disease according to RECIST 1.1.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- •Age = 18 years.
- •Life expectancy of at least three (3) months.
- •Written informed consent that is consistent with ICH-GCP guidelines.
排除标准
- •Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
- •Prior treatment with EGFR targeting small molecules or antibodies.
- •Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
- •Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids and/or leptomeningeal disease).
- •Any other current malignancy or malignancy diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer).
- •Known pre-existing interstitial lung disease.
- •Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn´s disease, malabsorption or CTC grade =2 diarrhoea of any aetiology.
- •History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
- •Cardiac left ventricular function with resting ejection fraction of less than 50%.
- •Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- •Absolute neutrophil count (ANC) < 1500 / mm^3.
- •Platelet count < 100,000 / mm^3.
- •Creatinine clearance < 60 ml / min or serum creatinine > 1.5 times upper limit of normal.
- •Bilirubin > 1.5 times upper limit of normal.
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) > three times the upper limit of normal (ULN) (if related to liver metastases > five times ULN).
- •Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial.
- •Pregnancy or breast-feeding.
- •atients unable to comply with the protocol.
- •Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
- •Known or suspected active drug or alcohol abuse.
- •Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.2.
- •Any contraindications for therapy with pemetrexed, cisplatin or dexamethasone.
- •Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
- •Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations).
研究者
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