Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT01163058
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
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.
- Detailed Description
Non small cell lung cancer patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 1 year
- Secondary Outcome Measures
Name Time Method Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. 1 year
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy