EUCTR2009-012983-14-HU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 (stage IIIB/IV) primary adenocarcinoma of the lung treated with docetaxel or paclitaxel plus cisplatin
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 or cytological diagnosis of inoperable
- •advanced (stage IIIB/IV) primary adenocarcinoma (including bronchioalveolar
- •cell carcinoma) of the lung.
- •2. All patients must have documented stage IIIB disease with malignant pleural or
- •pericardial effusions or stage IV disease.
- •3. Patients may have newly diagnosed or recurrent/relapsed disease.
- •4. No form of any prior systemic treatment 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 are allowed provided that any such therapy is completed and any radiation-induced sequelae
- •are recovered at least 21 days before receiving study treatment.
- •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 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.
- •11. Patients must have adequate bone marrow, adequate hepatic function, and a
- •baseline serum creatinine level documented by specific laboratory criteria:
- •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.
- •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,
- •Prior surgical resection of primary adenocarcinoma of the lung that occurred
- •more than one year prior to randomization,
- •Curatively-treated basal cell carcinoma,
- •Squamous cell carcinoma of the skin, or
- •Carcinoma in situ of the cervix.
- •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
- •1. Patients with small cell, squamous cell, large cell, or undifferentiated, or any form
- •of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma)
- •histopathological or cytological diagnosis of primary lung cancer.
- •2. Stage IIIB disease without malignant pleural or pericardial effusions, or Stage IIIIA
- •3. Patients with adenocarcinoma arising from any primary sites 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 of initial study treatment.
- •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 (including viral, fungal, bacterial, rickettsial,
- •mycobacterial, or parasitic), 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.
- •10. Patients who are pregnant or are breastfeeding.
- •11. Patients with a life expectancy of less than 5 months.
研究者
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