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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000740

Enrollment

Registered

2009-10-23

Start date

2009-08-31

Completion date

2010-04-30

Last updated

2010-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

EAP, Long term survival (3 years), Gefitinib, efficacy

Brief summary

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

Interventions

GENETICEGFR Mutation Test

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.

GENETICKi-67 protein expression

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Describe the quality of life of long-term survivors who are not terminated from the EAP	—

Secondary

Measure	Time frame
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.	—
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	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026