Clinical trial NCT01795352: Retrospective Study in a NSCLC M+ p
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGFR Mutated Non-small Cell Lung Cancer Patients
Keywords: EGFR,
lung cancer,
mutated
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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

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)

Primary outcomes:
measure: Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
timeFrame: 32 months
Secondary outcomes:
measure: Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.
timeFrame: 32 months
measure: Evaluation of overall response rate (ORR).
timeFrame: 32 months
measure: Evaluation of disease control rate (DCR).
timeFrame: 32 months
measure: Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).
timeFrame: 32 months
measure: Evaluation of overall survival (OS: median OS and 1 year OS rate).
timeFrame: 32 months
measure: 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.
timeFrame: 32 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Donostia
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Navarra
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: