Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients
- Conditions
- Metastatic Non-Small-Cell Lung Cancer
- Registration Number
- NCT01717105
- Lead Sponsor
- Grupo Gallego de Cancer de Pulmon
- Brief Summary
The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria for patients´ screening:
- Patients of both sexes aged 18 or more.
- Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
- Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
- Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
- Patients who have granted their written informed consent.
Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
Inclusion Criteria for patients´ follow-up
- Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
- Combined histology of non-small cell and small cell lung cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia 10 months (recruitment period)
- Secondary Outcome Measures
Name Time Method Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients) 1 day (Screening Visit) Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients) 1 day (Progresion Visit) Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients) From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier. Disease control (only for epidermal growth factor receptor (EGFR) M+ patients) From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up) Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening 1 day (Screening Visit) Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients) 1 day (First study visit) Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients) 1 day (Progression Visit) Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients) 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up
Trial Locations
- Locations (9)
Complexo Hospitalario Arquitecto Marcide
🇪🇸Ferrol, A Coruña, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital do Meixoeiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Xeral-Cíes
🇪🇸Vigo, Pontevedra, Spain
Complejo Hospitalario de Ourense
🇪🇸Ourense, Orense, Spain
Centro Oncologico de Galicia
🇪🇸A Coruña, Spain
Lucus Augusti Hospital
🇪🇸Lugo, Spain
Hospital Povisa
🇪🇸Vigo, Pontevedra, Spain
Complexo Hospitalario de Pontevedra
🇪🇸Pontevedra, Spain