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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Istituto Clinico Humanitas.