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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Non-small Cell Lung Cancer

Treatments: Genetic: EGFR Mutation Test; Genetic: Ki-67 protein expression

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000740

1839IL/0052 SubStudy

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

1

Experimental group

Description:

Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment

Treatment:

Genetic: EGFR Mutation Test

Genetic: Ki-67 protein expression

2

No Intervention group

Description:

Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP

3

No Intervention group

Description:

Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being