Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

NCT01163058 | Unknown

• 1 other identifier: ONC/OSS-01/2010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non small cell lung cancer patients treated with gefitinib or erlotinib

You may qualify if:

• 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

You may not qualify if:

• No tumor tissue available
• No clinical data available

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20059, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 15, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 29, 2010

Record last verified: 2010-07

Locations

IT (1)