EGFR Mutated Non-small Cell Lung Cancer Patients Clinical Trial
— Ca_PulmonOfficial 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
| Verified date | October 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of MedicinesSpain: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 187 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain. | 32 months | No | |
| Secondary | Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain. | 32 months | No | |
| Secondary | Evaluation of overall response rate (ORR). | 32 months | No | |
| Secondary | Evaluation of disease control rate (DCR). | 32 months | No | |
| Secondary | Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate). | 32 months | No | |
| Secondary | Evaluation of overall survival (OS: median OS and 1 year OS rate). | 32 months | No | |
| Secondary | 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. | TK- Tyrosine Kinase | 32 months | No |