Non Small Cell Lung Cancer Clinical Trial
Official title:
A Multi-centre, Naturalistic Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of EGFR TKI in Male Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer of Adeno Histology Failed 1st Line Chemotherapy
Verified date | September 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 186 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Taiwan | Research Site | Changhua | |
Taiwan | Research Site | Chiayi | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Tainan | |
Taiwan | Research Site | Taipe |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between smoking patterns and best objective tumor response rate | 6 Months | No | |
Secondary | correlation between smoking patterns and progression free survival (PFS) | 9 months | No | |
Secondary | correlation between smoking patterns and overall survival (OS) | 9 Months | No | |
Secondary | changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy | 3 Months | No |
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