Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

Grupo Gallego de Cancer de Pulmon225 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

225

Conditions

Metastatic Non-Small-Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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+). Exclusion Criteria: * Combined histology of non-small cell and small cell lung cancer.

Locations (9)

Centro Oncologico de Galicia

A Coruña, A Coruña, Spain

Complexo Hospitalario Arquitecto Marcide

Ferrol, A Coruña, Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Lucus Augusti Hospital

Outcomes

Primary Outcomes

Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia

Time frame: 10 months (recruitment period)

Secondary Outcomes

Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening

Time frame: 1 day (Screening Visit)

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)

Time frame: 1 day (Screening Visit)

Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)

Time frame: 1 day (First study visit)

Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)

Time frame: 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)

Time frame: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)

Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)

Time frame: 1 day (Progression Visit)

Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)

Time frame: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up

Data from ClinicalTrials.gov

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