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

Non-small Cell Lung Cancer Clinical Trial

— EARLY-EGFR  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742192
• Other study ID #: D5161R00028
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Rosario - Santa Fe
Chile	Research Site	Santiago de Chile
Chile	Research Site	Santiago de Chile
Colombia	Research Site	Bogotá
Colombia	Research Site	Montería -Cordoba
Costa Rica	Research Site	San Jose
Dominican Republic	Research Site	Santo Domingo
Egypt	Research Site	Alexandria
Egypt	Research Site	Cairo
Egypt	Research Site	Tanta
India	Research Site	Kashmir
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	New Delhi
Kuwait	Research Site	Kuwait City
Mexico	Research Site	Cdmx
Mexico	Research Site	Guadalajara
Mexico	Research Site	Monterrey
Peru	Research Site	Lima
Peru	Research Site	Lima
Philippines	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
Singapore	Research Site	Singapore
Thailand	Research Site	Bangkok
Thailand	Research Site	Muang
Turkey	Research Site	Ankara
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Costa Rica,  Dominican Republic,  Egypt,  India,  Kuwait,  Mexico,  Peru,  Philippines,  Singapore,  Thailand,  Turkey,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with a tumour PD-L1 IHC test result	Proportion of patients with PD-L1 positivity at various cut-points (<1%, =1%, =50%) grouped according to: EGFRm; EGFR wild type	3 Month
Primary	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
Primary	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	Proportion of patients with the EGFRm types	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
Secondary	Proportion of patients who were prescribed modalities	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

External Links

•   Redacted CSR synopsis