Retrospective Study in a NSCLC M+ p

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01795352

Acronym

Ca_Pulmon

Enrollment

187

Registered

2013-02-20

Start date

2013-03-31

Completion date

2013-10-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Mutated Non-small Cell Lung Cancer Patients

Keywords

EGFR,, lung cancer,, mutated

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

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results