Clinical trial · Interventional
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
NCT01000740CI-TRIAL-00003468completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR Mutation Test | Genetic | — | UNRESOLVED |
| Ki-67 protein expression | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
- interventionNames
- Genetic: EGFR Mutation Test
- Genetic: Ki-67 protein expression
- type
- NO_INTERVENTION
- label
- 2
- description
- Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
- type
- NO_INTERVENTION
- label
- 3
- description
- Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLi L, Zhong W, Liao M, Chen L, Han B, Guan Z, Yu S, Liu X, Wu Y, Jiang G, Xu J, Chen J, Tao M, Luo R, Li W, Xu N, Zhao X, Wang M. [A study on the long-term non-small cell lung cancer survivors in the Expand Access Program of gefitinib in China]. Zhongguo Fei Ai Za Zhi. 2012 Jun;15(6):332-9. doi: 10.3779/j.issn.1009-3419.2012.06.03. Chinese. PMID 22681919