EUCTR2007-002135-83-RO进行中（未招募）1 期
An open label study to evaluate the effect of first line treatment with Tarceva in combination with Gemcitabine on disease progression in patients with unresectable advanced and/or metastatic non-small cell lung cancer
Roche Romania SR0 个研究点开始时间: 2017年2月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •Histological or cytological documented diagnosis of advanced and/or metastatic (stage IIIB/ IV) chemotherapy-naive, unresectable, non-small cell lung cancer (NSCLC)
- •Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria
- •18 years of age or older
- •ECOG performance status >/= 2
- •Life expectancy of at least 12 weeks.
- •Patients with advanced stage IIIB /IV NSCLC who did not received any course of standard systemic chemotherapy or radiation therapy or immunotherapy.
- •Patients who, in the opinion of the investigator, are not suitable for surgery.Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
- •Patients must have prescription for Gemcitabine 1000mg/m² iv D1, D8, D15 (q28) at the time of study enrollment.
- •Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L
- •Serum bilirubin must be < 1.5 upper limit of normal (ULN).
- •AST and/or ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis
- •Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min
- •Able to comply with study and follow-up procedures
- •For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
- •Patients with reproductive potential must use effective contraception
- •Written (signed) Informed Consent to participate in the study
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Any active, non-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- •Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
- •Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- •Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
- •Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient’s treating Oncologist and the ophthalmologist.
- •Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- •Nursing mothers.
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