Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer (EARLY-EGFR)
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- STATUS
- Recruiting
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- End date
- Nov 30, 2022
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- participants needed
- 550
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- sponsor
- AstraZeneca
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.
Details
| Condition | Non-small Cell Lung Cancer |
|---|---|
| Clinical Study Identifier | NCT04742192 |
| Sponsor | AstraZeneca |
| Last Modified on | 25 July 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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