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NCT Number: NCT04742192

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Rosario - Santa Fe, Argentina

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About this study

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. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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 -

Treatment and study plan

Primary outcomes

  1. Overall proportion of patients with EGFRm

    Time frame: 3 month

    Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:

    o Histology (adenocarcinoma, bronchiole-alveolar, large cell carcinoma, mixed, other, unknown)

  2. Proportion of EGFRm in Pathologic Stage

    Time frame: 3 Month

    Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:

    o Pathologic stage (IA, IB, IIA, IIB, IIIA, IIIB with lymph node metastasis status [N0, N1, and N2])b

Secondary outcomes

  1. Proportion of patients with the EGFRm types

    Time frame: 3 Month

    Proportion of patients with the following EGFRm types:

    • Exon19 deletions
    • Exon21 L858R
    • Exon20 T790M
    • Others (compound mutationsb, uncommon mutations [including G719X, L861Q, S768I, and 20 insertions])

  2. Proportion of patients who were prescribed modalities

    Time frame: 3 Month

    Proportion of patients who were prescribed these modalities:

    • Only surgical resection
    • Surgical resection and radiotherapy
    • Surgical resection and systemic therapy (neoadjuvant and/or adjuvant)
    • Surgical resection, radiotherapy and systemic therapy (neoadjuvant and/or adjuvant)

Other outcomes

  1. Proportion of patients with a tumour PD-L1 IHC test result

    Time frame: 3 Month

    Proportion of patients with PD-L1 positivity at various cut-points (<1%, ≥1%, ≥50%) grouped according to:

    • EGFRm
    • EGFR wild type

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer

Acronym: EARLY-EGFR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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