EUCTR2014-001207-42-IT进行中（未招募）1 期
Multicenter randomized trial comparing erlotinib vs mono-chemotherapy in the third-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR-mutated or unknown
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 538
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 diagnosis of NSCLC in stage IIIB -IV, according to the 7th TNM .
- •State of EGFR - mutated or unknown .
- •Patients who have received two prior lines of chemotherapy for advanced disease, the last of which ended at least three weeks. They are also eligible patients who have already received, in addition to 2 lines of chemotherapy; more than 1 line of treatment different from chemotherapy provided no EGFR inhibitors (see exclusion criterion 1).
- •Written informed consent.
- •Age = 18 years.
- •Performance Status (PS ) = 2 of the ECOG scale .
- •Life expectancy of at least 12 weeks.
- •Is permitted radiotherapy with palliative intent before starting treatment.
- •X-ray examination should be used as a baseline evaluation was performed within 28 days of the start of chemotherapy.
- •Baseline hematological examinations performed within 7 days prior to enrollment , with the following values : hemoglobin = 9 g / dl , = 1.500/mm3 neutrophils , platelets = 100.000/mm3 , total bilirubin = 1.5 times the upper limit of normal , ALT , AST = 2 times the upper limit of normal , creatinine within the normal range.
- •When it comes to women of childbearing age, the patient should make use of appropriate means of contraception.
- •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 238
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Patients who have received prior EGFR inhibitors.
- •Patients who have previously received gemcitabine (in case of non-squamous histology) or vinorelbine (in the case of squamous histology). * (See section 7.3)
- •Patients with brain metastases are not controlled.
- •Patients who are currently treated with experimental agents or who have interrupted a clinical study of not less than 30 days.
- •Patients who have ongoing infections or uncontrolled diabetes mellitus or heart disease grade III-IV NYHA or other serious disease ..
- •Patients with cancer with ALK rearrangement.
研究者
相似试验
已完成
3 期
Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancerJPRN-UMIN000002314ational Hospital Organization Headquarters Center for Support and Education of Clinical Research300
已完成
3 期
Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation (NEJ026)Advanced non-squamous non-small cell lung cancerJPRN-UMIN000017069orth East Japan Study Group (NEJSG)214
进行中（未招募）
不适用
A randomized phase II study of erlotinib compared to single agent chemotherapy-erlotinib combination in pretreated patients with advanced NSCLC (NVALT10 study) - NVALT10patients who failed previous cytotoxic treatment for non-small-cell lung cancer locally advanced and metastatic disease stage IIIB and IVMedDRA version: 9.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBMedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVEUCTR2009-009315-22-NLVALT230
已完成
2 期
Multicenter Phase II study of erlotinib therapy in recurrent or advanced non-small cell lung cancer patients with Epidermal Growth Factor Receptor (EGFR) mutatioon small cell lung cancer with Epidermal Growth Factor Receptor mutationJPRN-UMIN000003270ung Oncology Group in Kyushu, Japan (LOGIK)26
已完成
3 期
A randomized phase III study of erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed as first-line therapy for advanced EGFR mutated non-small-cell lung cancer. the NVALT-17 studylung cancernon-small cell lung cancerNL-OMON45179Stichting NVALT studies150