Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia

Grupo Gallego de Cancer de Pulmon9 sites in 1 country225 target enrollmentMarch 2011

ConditionsMetastatic Non-Small-Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Non-Small-Cell Lung Cancer
Sponsor: Grupo Gallego de Cancer de Pulmon
Enrollment: 225
Locations: 9
Primary Endpoint: Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

February 2013

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Grupo Gallego de Cancer de Pulmon

Responsible Party

Sponsor

Eligibility Criteria

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.

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

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)