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

Phase 4CompletedNCT01000740

AstraZeneca59 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

EGFR Mutation TestGENETIC

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.

Ki-67 protein expressionGENETIC

Ki-67 protein expression in tissue will be analysed by IHC method.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (9)

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guangdong, China

Research Site

Wuhan, Hubei, China

Research Site

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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