Clinical trial NCT01717105: Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Non-Small-Cell Lung Cancer
Keywords: Non-small cell lung cancer (NSCLC)
Epidermal growth factor receptor (EGFR) positive mutation
Lead sponsor: Grupo Gallego de Cancer de Pulmon
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Dynamic Solutions
First posted: 2012-10-30
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient consultation in oncology

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.


Eligibility 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.

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
timeFrame: 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
timeFrame: 1 day (Screening Visit)
measure: 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)
timeFrame: 1 day (Screening Visit)
measure: Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)
timeFrame: 1 day (First study visit)
measure: Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)
timeFrame: 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.
measure: Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)
timeFrame: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)
measure: Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)
timeFrame: 1 day (Progression Visit)
measure: Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)
timeFrame: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up
measure: 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)
timeFrame: 1 day (Progresion Visit)
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complexo Hospitalario Arquitecto Marcide
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
state: Orense
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
state: Pontevedra
city: Vigo
country: Spain
facility: Hospital Xeral-Cíes
state: Pontevedra
city: Vigo
country: Spain
facility: Hospital Povisa
state: Pontevedra
city: A Coruña
country: Spain
facility: Centro Oncologico de Galicia
city: Lugo
country: Spain
facility: Lucus Augusti Hospital
city: Pontevedra
country: Spain
facility: Complexo Hospitalario de Pontevedra
Study officials:
affiliation: Grupo Gallego de Cáncer de Pulmón (GGCP)
name: Sergio Vázquez Estévez, Doctor
role: STUDY_DIRECTOR
References: