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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- EGFR Mutated Non-small Cell Lung Cancer Patients
- Sponsor
- AstraZeneca
- Enrollment
- 187
- Locations
- 1
- Primary Endpoint
- Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Detailed Description
Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
- •Confirmed EGFR mutation by a validated test
- •Availability of medical record
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Time Frame: 32 months
Secondary Outcomes
- 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 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)
- Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics.(32 months)
- Evaluation of disease control rate (DCR).(32 months)