A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa

Study Overview
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Brief Summary
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The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Genetic: EGFR Mutation Test
* Genetic: Ki-67 protein expression


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment | Genetic: EGFR Mutation Test<br>* Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.<br>Genetic: Ki-67 protein expression<br>* Ki-67 protein expression in tissue will be analysed by IHC method.<br>|
| No Intervention: 2<br>Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP | |
| No Intervention: 3<br>Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the quality of life of long-term survivors who are not terminated from the EAP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the current tumour control status via RECIST |  |  | 
| To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.) |  |  | 
| To describe the treatment compliance of gefitinib in these patients |  |  | 
| To describe the current clinical status of long-term survivors in the EAP program by clinical |  |  | 
| To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EAP, Long term survival (3 years), Gefitinib, efficacy