Non-small Cell Lung CancerPhase 4NCT01000740
A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
A Phase 4 study testing EGFR Mutation Test and Ki-67 protein expression in people with Non-small Cell Lung Cancer, run by AstraZeneca at 9 sites in China.
Trial summary
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- EGFR Mutation Test and Ki-67 protein expression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 9 sitesChina
- Study dates
- Aug 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Research Site
Beijing, Beijing Municipality
Research Site
Chengdu, Sichuan
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Jinan, Shandong
Research Site
Nanjing, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Suzhou, Jiangsu
Research Site
Wuhan, Hubei
About this study
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
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- EGFR Mutation Test, Ki-67 protein expression
- Keywords
- EAP, Long term survival (3 years), Gefitinib, efficacy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR Mutation TestGenetic
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 expressionGenetic
Ki-67 protein expression in tissue will be analysed by IHC method.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment Receives: Genetic: EGFR Mutation Test; Genetic: Ki-67 protein expression |
| 2 | No intervention | Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP |
| 3 | No intervention | Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the quality of life of long-term survivors who are not terminated from the EAP
Secondary outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Atkin, Study director, AstraZenecaLouis Zhang, Study chair, AstraZenecaLongyun Li, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000740
- Sponsor's protocol ID
- 1839IL/0052 SubStudy
- Status last verified
- May 2010
- First submitted
- 7 Sep 2009
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Li 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.
PubMed 22681919
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01000740
- Acronym / sponsor ID
- 1839IL/0052 SubStudy
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EAP, Long term survival (3 years), Gefitinib, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: EGFR Mutation Test, Genetic: Ki-67 protein expressionLong term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment |
| 2 | No intervention | –Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP |
| 3 | No intervention | –Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR Mutation TestExplore 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 | 1 |
| Ki-67 protein expressionKi-67 protein expression in tissue will be analysed by IHC method. | Genetic | 1 |
Primary outcome
Describe the quality of life of long-term survivors who are not terminated from the EAP
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2010.
- Derived from this study: PubMed 22681919Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Atkin study director
AstraZeneca
Louis Zhang study chair
AstraZeneca
Longyun Li principal investigator
Peking Union Medical College Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EGFR Mutation Test and Ki-67 protein expression in people with Non-small Cell Lung Cancer, run by AstraZeneca at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the quality of life of long-term survivors who are not terminated from the EAP. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2010; AzTrials last refreshed its copy on 1 Nov 2026.