Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non small cell lung cancer|
|Sponsor||Istituto Clinico Humanitas|
|Start date||June 2010|
|End date||July 2010|
|Trial size||300 participants|
|Trial identifier||NCT01163058, ONC/OSS-01/2010|
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
Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations.
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - No tumor tissue available - No clinical data available
|Official title||Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients|
|Principal investigator||Armando Santoro, MD|
|Description||Non small cell lung cancer patients.|
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