An International Expanded Access Clinical Programme With ZD1839 (IRESSATM) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC) China Amendment 1: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Phase 4
N/A
N/A
N/A
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
An International Expanded Access Clinical Programme With ZD1839 (IRESSATM) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC) China Amendment 1: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Participated in the Iressa EAP in China.
- Diagnosed as NSCLC.
- Patients who started EAP at least 3 years before this study initiated and have not
yet terminated from the EAP (active long-term survivors).
- Patients who consent to provide blood sample and available archival tumour tissue
sample for EGFR gene testing (provision of tumour tissue sample is optional).
Exclusion Criteria:
- Patients who disagree to participate this study.
- Patients in whose medical objection was recorded to use the existing data from
medical practice for scientific research.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Describe the quality of life of long-term survivors who are not terminated from the EAP
Safety Issue:
Yes
Principal Investigator
Karen Atkin
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
China: Ethics Committee
Study ID:
1839IL/0052 SubStudy
NCT ID:
NCT01000740
Start Date:
August 2009
Completion Date:
April 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- EAP
- Long term survival (3 years)
- Gefitinib
- efficacy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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