EUCTR2012-001896-35-HU进行中（未招募）1 期
A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor - EMPHASIS-lung: Erlotinib Maldi TOF Phase III Signature in Squamous cell non-small cell lung cancer
ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 500 人开始时间: 2012年8月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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 or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according to the 7th edition of the TNM classification, including M1a (separate
- •tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis).
- •- Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy.
- •- Adjuvant platinum-based chemotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration.
- •- Platinum-based chemotherapy combined with definitive
- •radiotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration.
- •Measurable or evaluable disease according to RECIST v1.1 .
- •ECOG performance status 0-2.
- •- Age = 18 years.
- •- Adequate organ function, including:
- •- Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- •- Hepatic: bilirubin <1.5 x ULN; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in case of liver metastasis.
- •- Renal: calculated creatinine clearance > 40 ml/min based on the Cockroft and Gault formula.
- •- Signed and dated informed consent form.
- •- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with reproductive potential must have a negative serum or urin pregnancy test within 7 days prior to study registration. Non-reproductive potential for females is defined as surgically sterile or post-menopausal defined as =24 months since last menses. Male patients are considered to have reproductive potential unless they are surgically sterile.
- •- Estimated life expectancy >12 weeks.
- •- Patient compliance and geographical proximity that allow adequate follow-up.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Evidence of other medical conditions which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus).
- •- Previous treatment with any EGFR-TKI or docetaxel.
- •- Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to registration.
- •- Documented presence of activating EGFR mutations, if patient was tested for EGFR mutations.
- •- Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized nonmelanoma skin cancer.
- •- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake.
- •- Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to registration.
- •- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated.
- •- Pregnant women
- •- Nursing women
研究者
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