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

G

Grupo Gallego de Cancer de Pulmon

Status

Unknown

Conditions

Metastatic Non-Small-Cell Lung Cancer

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01717105
GGCP 048-10
GGC-CPN-2010-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

225 participants in 1 patient group

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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