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

Metastatic Non-Small-Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01717105
• Other study ID #: GGCP 048-10
• Secondary ID: GGC-CPN-2010-01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 26, 2012
• Last updated: November 5, 2012
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2012
• Source: Grupo Gallego de Cancer de Pulmon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-Small-Cell Lung Cancer

Locations

Country	Name	City	State
Spain	Centro Oncologico de Galicia	A Coruña
Spain	Complexo Hospitalario Arquitecto Marcide	Ferrol	A Coruña
Spain	Lucus Augusti Hospital	Lugo
Spain	Complejo Hospitalario de Ourense	Ourense	Orense
Spain	Complexo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital do Meixoeiro	Vigo	Pontevedra
Spain	Hospital Povisa	Vigo	Pontevedra
Spain	Hospital Xeral-Cíes	Vigo	Pontevedra

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Gallego de Cancer de Pulmon	AstraZeneca, Dynamic Solutions

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening		1 day (Screening Visit)	No
Secondary	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)	No
Secondary	Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)		1 day (First study visit)	No
Secondary	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.	No
Secondary	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)	No
Secondary	Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)		1 day (Progression Visit)	No
Secondary	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	No
Secondary	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)	No