Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01163058
Recruitment Status : Unknown
Verified July 2010 by Istituto Clinico Humanitas. Recruitment status was: Active, not recruiting
Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.
Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib [ Time Frame: 1 year ]
Secondary Outcome Measures :
Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
non small cell lung cancer patients treated with gefitinib or erlotinib
Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
Metastatic disease treated with gefitinib or erlotinib
Presence of at least one measurable lesion according to RECIST criteria