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Completed

NCT Number: NCT01000740

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EGFR Mutation Test

Genetic

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

Genetic

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

Primary outcomes

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

Secondary outcomes

  1. To describe the current tumour control status via RECIST

  2. 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.)

  3. To describe the treatment compliance of gefitinib in these patients

  4. To describe the current clinical status of long-term survivors in the EAP program by clinical

  5. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2009
Registry last updated
May 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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