EUCTR2009-012983-14-BG进行中（未招募）不适用
Randomized, multicenter, double-blind, phase 3 trial of Tavocept versus Placebo in patients with newly diagnosed or relapsed advanced primary adenocarcinoma of the lung treated with docetaxel or paclitaxel plus cisplatin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 575
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
- •1. Patients with confirmed histopathological diagnosis of inoperable advanced (stage IV) primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung. If pathological, or radiological findings are inconclusive for a diagnosis of primary adenocarcinoma of the lung, additional studies must be performed to confirm primary lung versus metastatic adenocarcinoma.
- •2. All patients must have documented Stage IV disease in accordance with the AJCC TNM staging system 7th edition (M1a=separate tumor nodule[s] in a contralateral lobe; tumor with pleural nodules or malignant pleural or pericardial effusion, M1b= distant metastases).
- •3. Patients may have newly diagnosed or recurrent/relapsed disease.
- •4. No form of any prior systemic treatment is allowed for non-small cell lung cancer, including chemotherapy, immunotherapy (e.g., monoclonal antibodies, vaccines), hormonal therapy (excluding dexamethasone or corticosteroids), targeted therapies (including EGFR inhibitors), or investigational drugs.
- •5. Prior radiation therapy is allowed, provided that at least one (1) area of measurable (by CT scan) or evaluable disease by RECIST (Version 1.1) that has not been subject to prior irradiation.
- •6. Prior prophylactic cranial irradiation (PCI) or radiation therapy is allowed provided that any such therapy is completed and any radiation-induced sequelae are recovered at least 21 days before randomization.
- •7. Patients with an ECOG performance status of 0 or 1.
- •8. Patients who are at least 18 years of age.
- •9. Patients with documented stable CNS metastases with no cognitive deficits, or progressive sensory or motor deficits or seizures during the last 21 days prior to randomization are eligible. Patients must have discontinued anti-seizure medications and steroids at least 21 days prior to patient randomization.
- •10. Patients must have fully recovered from any prior major surgical or diagnostic staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative status of at least 30 days before randomization.
- •11. Patients must have adequate bone marrow, adequate hepatic function, and a baseline creatinine levels documented by specific laboratory criteria within
- •21 days prior to randomization :
- •Absolute neutrophil count (ANC) = 1.5 × 109/L
- •Hemoglobin = 10 g/dL
- •Platelet count = 100 × 109/L
- •Total bilirubin < the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST/SGOT) = 1.5 × ULN
- •Alanine aminotransferase (ALT/SGPT) = 1.5 × ULN
- •Alkaline phosphatase = 2.5 × ULN
- •Baseline serum creatinine level no greater than 1.5 mg/dL or 133 µmol/L.
- •Creatinine clearance = 60 mL/min, calculated using a modified Cockcroft-Gault formula2 (see Table 1 for the formula).
- •Magnesium = 1.7 mg/dL
- •12. Female patients of child-bearing potential must have a negative pregnancy test,
- •and must agree to use an acceptable contraceptive method during the study. Male
- •patients with partners of child-bearing potential must also agree to use an adequate
- •method of contraception.
- •13. Patients must have been disease-free at least 2 years for other malignancies,
- •Curatively-treated basal cell carcinoma,
- •Squamous cell carcinoma of the skin, or
- •Carcinoma in situ of the cervix.
- •14. Patients with prior surgical resection and no prior chemotherapy for
- •primary adenocarcinoma of the lung who have relapsed are allowed.
- •15. Provide written informed consent prior to any screening procedures
- •Are the trial subjects
排除标准
- •1. Patients with small cell, squamous cell, large cell, undifferentiated, mesothelioma,
- •or any form of mixed (e.g., small cell and adenocarcinoma or squamous and
- •adenocarcinoma) histopathological diagnosis of primary lung cancer.
- •2. Patients who do not have documented Stage IV disease (in accordance with AJCC TNM staging system 7th edition).
- •3. Patients with metastatic adenocarcinoma arising from any primary site other than the lung.
- •4. Patients with recent onset (within 6 months of randomization) of congestive heart
- •failure (New York Heart Association Classification Class II or greater), angina
- •pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia,
- •myocardial infarction, stroke, or transient ischemic attacks.
- •5. Patients with unstable CNS metastases (characterized by progressive
- •sensory/motor impairment, cognitive/speech impairment, or seizure activity)
- •within 21 days before randomization.
- •6. Patients who do not have at least one (1) measurable or non-measurable but
- •assessable disease site that has not been previously irradiated.
- •7. Patients who are known to be HIV-positive.
- •8. Patients with active infections, uncontrolled high blood pressure, uncontrolled
- •diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the
- •last 6 months, or other serious underlying medical condition.
- •9. Patients with documented hypersensitivity to any of the study medications or
- •supportive agents that may be used.
- •Patients who are pregnant or are breastfeeding.
- •11. Patients who have undergone blood transfusions within 10 days before
- •randomization.
研究者
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