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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000740
• Other study ID #: 1839IL/0052 SubStudy
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2009
• Last updated: May 20, 2010
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Genetic:
• EGFR 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.
• Ki-67 protein expression
Ki-67 protein expression in tissue will be analysed by IHC method.

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Chengdu	Sichuan
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Jinan	Shandong
China	Research Site	Nanjing	Jiangsu
China	Research Site	Shanghai	Shanghai
China	Research Site	Suzhou	Jiangsu
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the quality of life of long-term survivors who are not terminated from the EAP			Yes
Secondary	To describe the current tumour control status via RECIST			Yes
Secondary	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.)			Yes
Secondary	To describe the treatment compliance of gefitinib in these patients			Yes
Secondary	To describe the current clinical status of long-term survivors in the EAP program by clinical			Yes
Secondary	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.			Yes