A PHASE II TRIAL ON NON-SMALL-CELL LUNG CANCER STEM CELLS SENSITIVITY ASSAY (LUCAS)

未提供0 个研究点开始时间: 2013年8月19日最近更新: 2013年9月16日

适应症

试验速览

暂无简介。

•Histologically/cytologically confirmed diagnosis of metastatic NSCLC.
•Possibility to obtain tumor tissue form primary tumor or from an accessible metastatic site, or possibility to collect any neoplastic effusion.
•Performance status of 0-1 according to ECOG score.
•At least one measurable lesion according to RECIST criteria.
•At least one previous standard chemotherapy regimen and previous therapy with an EGFR-TKI if EGFR mutated or crizotinib (or other anti ALK agent) if ALK positive.
•Adequate hematological, renal and liver functions.
•Radiological evidence of disease progression to the last anticancer therapy.
•At least 21 days since the last chemotherapy or any anticancer dose.
•No concomitant comorbidity potentially interfering with the study.
•If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method (intrauterine contraceptive device (IUD), birth control pills, or barrier device) during and for three months after trial
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•No possibility to obtain tumor tissue or neoplastic effusion.
•Performance status >1 according to ECOG score.
•No measurable lesion(s)
•Life expectancy less than 3 months.
•Important comorbidity interfering with the study.
•Significant alteration of liver, hematological or renal function(s).
•Brain metastases. Patients with resected brain metastases, or with asimptomatic brain metastases already treated with radiotherapy are eligible if they not need for steroids or antiepilettic drugs.No informed consent form signature

发起方

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