Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer
EARLY-EGFR
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
1 other identifier
observational
601
14 countries
32
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedAugust 14, 2023
August 1, 2023
1.7 years
January 25, 2021
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Overall proportion of patients with EGFRm
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
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 Outcomes (2)
Proportion of patients with the EGFRm types
3 Month
Proportion of patients who were prescribed modalities
3 Month
Other Outcomes (1)
Proportion of patients with a tumour PD-L1 IHC test result
3 Month
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (33)
Research Site
Rosario - Santa Fe, Argentina, S2002RE, Argentina
Research Site
Buenos Aires, 1415, Argentina
Research Site
Santiago, 13123, Chile
Research Site
Santiago, 7500713, Chile
Research Site
Montería -Cordoba, Colombia, 230002, Colombia
Research Site
Bogotá, 110111, Colombia
Research Site
San José, 10103, Costa Rica
Research Site
Santo Domingo, 10105, Dominican Republic
Research Site
Alexandria, Egypt
Research Site
Cairo, Egypt
Research Site
Tanta, Egypt
Research Site
Kashmīr, India
Research Site
Kolkata, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Kuwait City, Kuwait
Research Site
Mexico City, Mexico City, 6720, Mexico
Research Site
Guadalajara, 64700, Mexico
Research Site
Monterrey, 44260, Mexico
Research Site
Lima, 15036, Peru
Research Site
Lima, 15074, Peru
Research Site
City of Taguig, Philippines, Philippines
Research Site
Iliolo City, Philippines, Philippines
Research Site
Cebu City, Philippines
Research Site
Makati, Philippines
Research Site
Manila, Philippines
Research Site
Quezon City, Philippines
Research Site
Singapore, Singapore
Research Site
Muang, Thailand, Thailand
Research Site
Bangkok, Thailand
Research Site
Ankara, Turkey (Türkiye)
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Related Publications (1)
Batra U, Prabhash K, Noronha V, Deshpande R, Khurana S, Bhat GM, Mistry R, Agarwala V, Rajpurohit S, Poladia B, Sharma M, Banday SZ. Prevalence of EGFR Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort. JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7.
PMID: 39772802DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
February 8, 2021
Study Start
March 4, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.