EUCTR2008-002018-23-IT进行中（未招募）不适用
MULTICENTRIC RANDOMIZED PHASE III STUDY COMPARING GEFITINIB VERSUS PLATINUM-BASED CHEMOTHERAPY IN EGFR FISH POSITIVE NSCLC PATIENTS (RANGE) - RANGE
FONDAZIONE HUMANITAS PER LA RICERCA0 个研究点开始时间: 2008年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Histologically confirmed diagnosis of non-squamous NSCLC. Availability of tumor tissue for EGFR FISH analysis is mandatory Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent EGFR FISH positive Presence of at least one measurable/evaluable not previously irradiated lesion according to RECIST criteria. Previously irradiated lesion(s) are allowed only if progressing ECOG performance Status 0-2 Patient untreated with chemotherapy or EGFR targeting agents. Adjuvant chemotherapy is allowed if disease relapsed after at least 12 months after therapy completion. Patient candidate to standard platinum-based chemotherapy Patient compliance to trial procedures Patients must be willing to complete the FACT-L questionnaire Age ≥ 18 years Written informed consent
- •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
- •EGFR FISH negative tumor Squamous-cell carcinoma, presence of neuroendocrine features or small cell carcinoma histology Impossibility to ascertain EGFR FISH status Concomitant radiotherapy Less than 30 days since completion of prior wide field chest radiotherapy or persistence of any radiotherapy related toxicity. Symptomatic brain metastases or newly diagnosed central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease and are not receiving steroid therapy. Known severe hypersensitivity to gefitinib or any of the excipients of this product Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy. Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin Any previous chemotherapy or EGFR targeting agents Pregnancy or lactating. Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy Males must be willing to practice acceptable methods of birth control whilst taking study medication to prevent pregnancy of a partner. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Concomitant use of phenytoin, carbamazepine, rifampicin, rifabutin, barbiturates or St John?s Wort (Hypercium). Serum bilirubin greater than 3 times the upper limit of reference range (ULRR Alanine amino transferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
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