Retrospective Study in a NSCLC M+ p

Completed

• Conditions: EGFR Mutated Non-small Cell Lung Cancer Patients

• Registration Number: NCT01795352
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Study Start: 2013-03
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.	32 months

Secondary Outcome Measures

Name	Time	Method
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	TK- Tyrosine Kinase
Evaluation of disease control rate (DCR).	32 months

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain