EUCTR2014-000349-59-IT进行中（未招募）不适用
METAL (METformin in Advanced Lung cancer) study: PHASE II STUDY OF METFORMIN PLUS ERLOTINIB IN SECOND LINE THERAPY OF STAGE IV NON SMALL CELL LUNG CANCER (NSCLC) PATIENTS
department of experimental and clinical medicine F. Magrassi0 个研究点目标入组 60 人开始时间: 2014年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Signed written informed consents
- •Patients be age >18 years
- •Patients must have histologically or cytologically confirmed non small cell carcinoma of the lung and are previously treated
- •Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system).
- •Patients must have a Life Expectancy of greater than 12 weeks.
- •Patients must have an ECOG performance status 0 or 1 (Karnofsky> 70%).
- •Patients must have normal organ and marrow function as defined below, within one week prior to randomization:
- •-Neutrophils> 1.5 x 109/L, platelets > 100 x 109/L, and hemoglobin >9 g/dL
- •-Bilirubin level either normalor <1.5 x ULN
- •-ASAT and ALAT <2.5 x ULN (< 5 x ULN if liver metastasis are present)
- •-Serum creatinine < 1.5 x ULN
- •-Alkaline phosphatase < 4 x ULN
- •O2 saturation >93%.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with EGFR/ALK mutated histologically proven NSCLC
- •Type 1 or 2 Diabetes
- •Patients with uncontrolled undercurrents illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- •Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.
- •Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or other agents used in the study are excluded.
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Any investigational agent(s) within 4 weeks prior to entry
- •Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Women who are pregnant or breastfeeding
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ? 5 years will be allowed to enter the trial)
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