Survey on the Treatment Reality of Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-small Cell Lung Cancer(NSCLC)
1 other identifier
observational
2,000
1 country
1
Brief Summary
According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However, the real situation and the reason are not clarified.This observational study collects the data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of approximately 20 facilities in Japan and observes the treatment reality of EGFR gene mutation-positive NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2016
CompletedMarch 27, 2017
March 1, 2017
9 months
June 12, 2015
March 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival of the patients.
Up to 3 monthes. Data will be collected retrospectively from medical records.Survival status as of the end of December 2014, date of death or date of last follow-up of survival.
Secondary Outcomes (4)
Overall survival by patient background
Up to 3 monthes. Data will be collected retrospectively from medical records.
Overall survival by treatment sequence
Up to 3 monthes. Data will be collected retrospectively from medical records.
Treatment time by treatment category
Up to 3 monthes. Data will be collected retrospectively from medical records.
Time to Treatment Failure (TTF) of Gefitinib treatment
Up to 3 monthes. Data will be collected retrospectively from medical records.
Eligibility Criteria
Approximately 2000, Advanced Non Small Cell Lung cancer (aNSCLC) patients who fulfil the inclusion/exclusion criteria will be recruited by 10 to 20 investigational sites in Japan.
You may qualify if:
- \. EGFR mutation-positive progress recurrent non-small cell lung cancer subject.
- \. Subjects who commenced on first-line treatment between January, 2008 and December 2012.
You may not qualify if:
- \. Patients has a treatment history with the drug which was not approved for marketing authorization as of 31th December , 2014
- \. Person who were planning and/or getting involved in this survey. (applies to both AstraZeneca staff and/or staff at the study site)
- \. Previous enrolment in the present study.
- \. Patient was not evaluated to be appropriate for study enrolment by the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Izumi Municipal Hospital
Izumi, Osaka, 594-0071, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 19, 2015
Study Start
June 19, 2015
Primary Completion
March 16, 2016
Study Completion
March 16, 2016
Last Updated
March 27, 2017
Record last verified: 2017-03