Overview

This trial is active, not recruiting.

Condition metastatic non-small-cell lung cancer
Sponsor Grupo Gallego de Cancer de Pulmon
Collaborator AstraZeneca
Start date March 2011
End date December 2012
Trial size 225 participants
Trial identifier NCT01717105, GGC-CPN-2010-01, GGCP 048-10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments

Primary Outcomes

Measure
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

Measure
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)
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)
Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: 1 day (First study visit)
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.
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)
Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: 1 day (Progression Visit)
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
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Grupo Gallego de Cancer de Pulmon.