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

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Genetic: EGFR Mutation Test; Genetic: Ki-67 protein expression

• Registration Number: NCT01000740
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	EGFR Mutation Test	Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
1	Ki-67 protein expression	Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment

Primary Outcome Measures

Name	Time	Method
Describe the quality of life of long-term survivors who are not terminated from the EAP

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hangzhou, Zhejiang, China