- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04742192
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
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
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, 1415
- Research Site
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Rosario - Santa Fe, Argentina, S2002RE
- Research Site
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Santiago de Chile, Chile, 13123
- Research Site
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Santiago de Chile, Chile, 7500713
- Research Site
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Bogotá, Colombia, 110111
- Research Site
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Montería -Cordoba, Colombia, 230002
- Research Site
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San Jose, Costa Rica, 10103
- Research Site
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Santo Domingo, Dominican Republic, 10105
- Research Site
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Alexandria, Egypt
- Research Site
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Cairo, Egypt
- Research Site
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Tanta, Egypt
- Research Site
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Kashmir, India
- Research Site
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Kolkata, India
- Research Site
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Mumbai, India
- Research Site
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New Delhi, India
- Research Site
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Kuwait City, Kuwait
- Research Site
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Cdmx, Mexico, 6720
- Research Site
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Guadalajara, Mexico, 64700
- Research Site
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Monterrey, Mexico, 44260
- Research Site
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Lima, Peru, 15036
- Research Site
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Lima, Peru, 15074
- Research Site
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Cebu City, Philippines
- Research Site
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Iliolo City, Philippines
- Research Site
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Makati, Philippines
- Research Site
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Manila, Philippines
- Research Site
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Quezon City, Philippines
- Research Site
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Taguig City, Philippines
- Research Site
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Singapore, Singapore
- Research Site
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Bangkok, Thailand
- Research Site
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Muang, Thailand
- Research Site
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Ankara, Turkey
- Research Site
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Hanoi, Vietnam, 100000
- Research Site
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Ho Chi Minh, Vietnam, 70000
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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:
- 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 -
Study Plan
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 |
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Overall proportion of patients with EGFRm
Time Frame: 3 month
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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
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Proportion of EGFRm in Pathologic Stage
Time Frame: 3 Month
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients with the EGFRm types
Time Frame: 3 Month
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Proportion of patients with the following EGFRm types:
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3 Month
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Proportion of patients who were prescribed modalities
Time Frame: 3 Month
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Proportion of patients who were prescribed these modalities:
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3 Month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients with a tumour PD-L1 IHC test result
Time Frame: 3 Month
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Proportion of patients with PD-L1 positivity at various cut-points (<1%, ≥1%, ≥50%) grouped according to:
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3 Month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5161R00028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
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.
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