Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Overview

To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).

Full Title of Study: “Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Cross-Sectional
• Study Primary Completion Date: August 2010

Clinical Trial Outcome Measures

Primary Measures

• To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).

Secondary Measures

• Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity
• To describe different EGFR mutation methods used in Spain and testing turn around time associated
• To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt)

Participating in This Clinical Trial

Inclusion Criteria

• Signed written informed consent
• Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)

Exclusion Criteria

• Mixed histology of small cell and non-small cell lung cancer

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • AstraZeneca
• Provider of Information About this Clinical Study
  • MC MD, AstraZeneca
• Overall Official(s)
  • Carmen Gonzalez Arenas, Study Director, Medical Department. Mediclin-AstraZeneca. Spain