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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01717105

Enrollment

225

Registered

2012-10-30

Start date

2011-03-31

Completion date

2013-02-28

Last updated

2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non-Small-Cell Lung Cancer

Keywords

Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) positive mutation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)
Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)	1 day (First study 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.
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 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
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)
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)

Countries

Spain

Outcome results