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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
Dynamic Solutions
Information provided by (Responsible Party):
Grupo Gallego de Cancer de Pulmon
ClinicalTrials.gov Identifier:
NCT01717105
First received: October 26, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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.


Condition
Metastatic Non-Small-Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Grupo Gallego de Cancer de Pulmon:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients) [ Time Frame: 1 day (First study visit) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients) [ Time Frame: 1 day (Progression Visit) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 1 day (Progresion Visit) ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Tumor tissue Plasma samples


Estimated Enrollment: 225
Study Start Date: March 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
metastatic non-small cell lung cancer
Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient consultation in oncology

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717105

Locations
Spain
Complexo Hospitalario Arquitecto Marcide
Ferrol, A Coruña, Spain, 15405
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
Complejo Hospitalario de Ourense
Ourense, Orense, Spain, 32005
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain, 36204
Hospital Povisa
Vigo, Pontevedra, Spain, 36211
Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36200
Centro Oncologico de Galicia
A Coruña, Spain, 15009
Lucus Augusti Hospital
Lugo, Spain, 27004
Complexo Hospitalario de Pontevedra
Pontevedra, Spain, 36071
Sponsors and Collaborators
Grupo Gallego de Cancer de Pulmon
AstraZeneca
Dynamic Solutions
Investigators
Study Director: Sergio Vázquez Estévez, Doctor Grupo Gallego de Cáncer de Pulmón (GGCP)
  More Information

No publications provided

Responsible Party: Grupo Gallego de Cancer de Pulmon
ClinicalTrials.gov Identifier: NCT01717105     History of Changes
Other Study ID Numbers: GGCP 048-10, GGC-CPN-2010-01
Study First Received: October 26, 2012
Last Updated: November 5, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Grupo Gallego de Cancer de Pulmon:
Non-small cell lung cancer (NSCLC)
Epidermal growth factor receptor (EGFR) positive mutation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014