Multicentre Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Male Patients
Completed
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT00922025
- Lead Sponsor
- AstraZeneca
- Brief Summary
The objective is to investigate the correlation between smoking pattern and clinical efficacy of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage, quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current practice of EGFR mutation testing in Taiwan will be surveyed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 186
Inclusion Criteria
- Male patients age 20 years or older
- Histological or cytological confirmation of NSCLC of adeno histology. If sputum is the only available sample, a second positive test is necessary for cytological confirmation
- Locally advanced or metastatic on or after first-line chemotherapy. Imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acceptable
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between smoking patterns and best objective tumor response rate 6 Months
- Secondary Outcome Measures
Name Time Method correlation between smoking patterns and progression free survival (PFS) 9 months correlation between smoking patterns and overall survival (OS) 9 Months changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy 3 Months
Trial Locations
- Locations (1)
Research Site
🇨🇳Taipe, Taiwan