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

August 10, 2023 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

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 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.

Study Type

Observational

Enrollment (Actual)

601

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1415
        • Research Site
      • Rosario - Santa Fe, Argentina, S2002RE
        • Research Site
      • Santiago de Chile, Chile, 13123
        • Research Site
      • Santiago de Chile, Chile, 7500713
        • Research Site
      • Bogotá, Colombia, 110111
        • Research Site
      • Montería -Cordoba, Colombia, 230002
        • Research Site
      • San Jose, Costa Rica, 10103
        • Research Site
      • Santo Domingo, Dominican Republic, 10105
        • Research Site
      • Alexandria, Egypt
        • Research Site
      • Cairo, Egypt
        • Research Site
      • Tanta, Egypt
        • Research Site
      • Kashmir, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Mumbai, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Kuwait City, Kuwait
        • Research Site
      • Cdmx, Mexico, 6720
        • Research Site
      • Guadalajara, Mexico, 64700
        • Research Site
      • Monterrey, Mexico, 44260
        • Research Site
      • Lima, Peru, 15036
        • Research Site
      • Lima, Peru, 15074
        • Research Site
      • Cebu City, Philippines
        • Research Site
      • Iliolo City, Philippines
        • Research Site
      • Makati, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
      • Taguig City, Philippines
        • Research Site
      • Singapore, Singapore
        • Research Site
      • Bangkok, Thailand
        • Research Site
      • Muang, Thailand
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh, Vietnam, 70000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

3 month
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

3 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
3 Month
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)
3 Month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

3
Subscribe