Retrospective Study in a NSCLC M+ p
Ca_Pulmon
Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain
1 other identifier
observational
187
1 country
12
Brief Summary
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals. At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2013
Shorter than P25 for all trials
12 active sites
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
February 18, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 30, 2013
October 1, 2013
7 months
February 18, 2013
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
32 months
Secondary Outcomes (6)
Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.
32 months
Evaluation of overall response rate (ORR).
32 months
Evaluation of disease control rate (DCR).
32 months
Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).
32 months
Evaluation of overall survival (OS: median OS and 1 year OS rate).
32 months
- +1 more secondary outcomes
Eligibility Criteria
All patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population.
You may qualify if:
- Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
- Confirmed EGFR mutation by a validated test
- Availability of medical record
You may not qualify if:
- Participating on a blinded randomized clinical trial at any time during the study period
- Pregnant women (due to they do not reflect daily clinical practice)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Barcelona, Barcelona, Spain
Research Site
Córdoba, Cordoba, Spain
Research Site
Donostia / San Sebastian, Donostia, Spain
Research Site
Granada, Granada, Spain
Research Site
León, Leon, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Málaga, Malaga, Spain
Research Site
Navarra, Navarre, Spain
Research Site
Seville, Sevilla, Spain
Research Site
Toledo, Toledo, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Zaragoza, Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2013
First Posted
February 20, 2013
Study Start
March 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 30, 2013
Record last verified: 2013-10