A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
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ClinicalTrials.gov Identifier: NCT01000740 |
Recruitment Status :
Completed
First Posted : October 23, 2009
Last Update Posted : May 21, 2010
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer | Genetic: EGFR Mutation Test Genetic: Ki-67 protein expression | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
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Experimental: 1
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
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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. Genetic: Ki-67 protein expression Ki-67 protein expression in tissue will be analysed by IHC method. |
No Intervention: 2
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
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No Intervention: 3
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
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- Describe the quality of life of long-term survivors who are not terminated from the EAP
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000740
China, Beijing | |
Research Site | |
Beijing, Beijing, China | |
China, Guangdong | |
Research Site | |
Guangzhou, Guangdong, China | |
China, Hubei | |
Research Site | |
Wuhan, Hubei, China | |
China, Jiangsu | |
Research Site | |
Nanjing, Jiangsu, China | |
Research Site | |
Suzhou, Jiangsu, China | |
China, Shandong | |
Research Site | |
Jinan, Shandong, China | |
China, Shanghai | |
Research Site | |
Shanghai, Shanghai, China | |
China, Sichuan | |
Research Site | |
Chengdu, Sichuan, China | |
China, Zhejiang | |
Research Site | |
Hangzhou, Zhejiang, China |
Study Director: | Karen Atkin | AstraZeneca | |
Study Chair: | Louis Zhang | AstraZeneca | |
Principal Investigator: | Longyun Li | Peking Union Medical College Hospital |
Responsible Party: | MC MD, AstraZeneca China |
ClinicalTrials.gov Identifier: | NCT01000740 |
Other Study ID Numbers: |
1839IL/0052 SubStudy |
First Posted: | October 23, 2009 Key Record Dates |
Last Update Posted: | May 21, 2010 |
Last Verified: | May 2010 |
EAP Long term survival (3 years) Gefitinib efficacy |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |