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

NCT04742192

CompletedN/A

Sponsor: AstraZeneca

Conditions: Non-small Cell Lung Cancer

Countries: Argentina, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, India, Kuwait

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 NSCLC up to 6 weeks prior to enrolment into the study. The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

Patients who fulfil any of the following exclusion criteria will not be eligible for the study:

1. Histology of the tumour is considered not to be of primary lung in origin
2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -
Locations (33)
  • Rosario - Santa Fe, Argentina, Argentina
  • Buenos Aires, Argentina
  • Santiago, Chile
  • Santiago, Chile
  • Montería -Cordoba, Colombia, Colombia
  • Bogotá, Colombia
  • San José, Costa Rica
  • Santo Domingo, Dominican Republic
  • Alexandria, Egypt
  • Cairo, Egypt
  • Tanta, Egypt
  • Kāshmir, India
  • Kolkata, India
  • Mumbai, India
  • New Delhi, India
  • Kuwait City, Kuwait
  • Mexico City, Mexico City, Mexico
  • Guadalajara, Mexico
  • Monterrey, Mexico
  • Lima, Peru
  • Lima, Peru
  • City of Taguig, Philippines, Philippines
  • Iliolo City, Philippines, Philippines
  • Cebu City, Philippines
  • Makati, Philippines
  • Manila, Philippines
  • Quezon City, Philippines
  • Singapore, Singapore
  • Muang, Thailand, Thailand
  • Bangkok, Thailand
  • + 3 more on CT.gov