RPCEC00000208招募中3 期
Survival of patients with advanced Non Small Cells Lung Cancer and EGF concentration in sera highest than 870 pg/mL that receive CIMAvax EGF© as maintenance therapy.
Centre for Molecular Immunology0 个研究点目标入组 100 人开始时间: 2016年1月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: No intervention. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV
- •2. Aged >18 years
- •3. EGF serum concentration > 870 pg/mL
- •4. Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that:
- •-Hemoglobin = 9 g/L
- •-White blood cell (WBC) count = 3000/ µL
- •-Neutrophils = 1500/µL
- •-Platelet count = 100,000 per µL
- •-Total bilirrubin in normal labs values
- •-Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN) Serum creatinine = 1.5 x ULN
- •5. Life expectancy at least 3 years
- •6. Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential.
- •7. Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation.
- •8. Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up.
- •9. Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy).
- •10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- •11. Achieve tumor Objective Response of at least stable disease by RECIST
排除标准
- •1. EGF serum concentration = 870 pg/mL
- •2. Patient is currently enrolled in other investigational drug trial.
- •3. Patient has a history of any severe or life-threatening hypersensitivity reaction.
- •4. Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease).
- •5. Pregnant woman6. Another active concurrent malignant disease except non- melanoma skin lesions or cervix cancer.
- •6. Brain metastases (Only if detectable by radiological image scan previous sign or symptoms)
研究者
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