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

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 Overview

• Status: Unknown
• Conditions: Metastatic Non-Small-Cell Lung Cancer

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15009
    • Centro Oncológico de Galicia
  • Lugo, Spain, 27004
    • Lucus Augusti Hospital
  • Pontevedra, Spain, 36071
    • Complexo Hospitalario De Pontevedra
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Complexo Hospitalario Arquitecto Marcide
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela
  • Orense
    • Ourense, Orense, Spain, 32005
      • Complejo Hospitalario de Ourense
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Hospital Do Meixoeiro
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral-Cíes
    • Vigo, Pontevedra, Spain, 36211
      • Hospital Povisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatient consultation in oncology

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
metastatic non-small cell lung cancer; Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Grupo Gallego de Cancer de Pulmon
• Collaborators: AstraZeneca; Dynamic Solutions
• Investigators: Study Director: Sergio Vázquez Estévez, Doctor, Grupo Gallego de Cáncer de Pulmón (GGCP)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer (NSCLC); Epidermal growth factor receptor (EGFR) positive mutation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GGCP 048-10; GGC-CPN-2010-01 (Other Identifier: AEMPS)