Status:

COMPLETED

Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer

Lead Sponsor:

AstraZeneca

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Brief Summary

This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous...

Detailed Description

This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous...

Eligibility Criteria

Inclusion

  • Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations
  • Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
  • Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks
  • Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
  • Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC

Exclusion

  • Patients who fulfil any of the following exclusion criteria will not be eligible for the study:
  • Histology of the tumour is considered not to be of primary lung in origin
  • Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -

Key Trial Info

Start Date :

March 4 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 30 2022

Estimated Enrollment :

601 Patients enrolled

Trial Details

Trial ID

NCT04742192

Start Date

March 4 2021

End Date

November 30 2022

Last Update

August 14 2023

Active Locations (33)

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Page 1 of 9 (33 locations)

1

Research Site

Rosario - Santa Fe, Argentina, Argentina, S2002RE

2

Research Site

Buenos Aires, Argentina, 1415

3

Research Site

Santiago, Chile, 13123

4

Research Site

Santiago, Chile, 7500713