Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01163058

Enrollment

300

Registered

2010-07-15

Start date

2010-06-30

Completion date

2011-07-31

Last updated

2010-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations.	1 year

Countries

Italy

Outcome results