Retrospective Study in a NSCLC M+ p (Ca_Pulmon)

October 29, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Donostia, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Leon, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Navarra, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Toledo, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Time Frame: 32 months
32 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Time Frame: 32 months
32 months
Evaluation of overall response rate (ORR).
Time Frame: 32 months
32 months
Evaluation of disease control rate (DCR).
Time Frame: 32 months
32 months
Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).
Time Frame: 32 months
32 months
Evaluation of overall survival (OS: median OS and 1 year OS rate).
Time Frame: 32 months
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.
Time Frame: 32 months
TK- Tyrosine Kinase
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OES-XXX-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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