Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)
NCT ID: NCT04031898
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
896 participants
OBSERVATIONAL
2019-05-07
2019-12-31
Brief Summary
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Detailed Description
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It is anticipated that data, generated from the proposed large cohort across centers in Europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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full analysis set
All eligible patients who meet all inclusion criteria and none of the exclusion criteria
Non Interventional
This is a non interventional, observational, retrospective study including patients with EGFR-mutated advanced NSCLC, treated with 1st or 2nd generation EGFR TKI therapy in first line
Interventions
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Non Interventional
This is a non interventional, observational, retrospective study including patients with EGFR-mutated advanced NSCLC, treated with 1st or 2nd generation EGFR TKI therapy in first line
Eligibility Criteria
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Inclusion Criteria
* Aged at least 18 years at first diagnosis of locally advanced/metastatic NSCLC;
* Lab-confirmed EGFR mutation;
* Received a first- or second-generation EGFR TKI as first-line treatment for advanced/metastatic disease;
* First-line EGFR TKI (afatinib, gefitinib, erlotinib) initiated between January 1, 2015 and June 30, 2018;
* Patients may be alive or deceased at the time of medical record review.
Exclusion Criteria
* Patients receiving any systemic therapy for locally advanced or metastatic NSCLC prior to first-line EGFR TKI treatment in the locally advanced/metastatic setting;
* Missing or unknown data on any of the following key study dates:
* Date of initial NSCLC diagnosis;
* Date of first diagnosis of or progression to advanced/metastatic NSCLC;
* Date of first-line EGFR TKI initiation for advanced/metastatic disease;
* Date of death or last available follow-up.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Konstantinos Syrigos, Prof.
Role: PRINCIPAL_INVESTIGATOR
Oncology Unit, Athens University School of Medicine,
Locations
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Research Site
Wien, , Bulgaria
Countries
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References
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Janzic U, Turnsek N, Dediu M, Donev IS, Lupu R, Teodorescu G, Ciuleanu TE, Pluzanski A. Real-World Testing Practices, Treatment Patterns and Clinical Outcomes in Patients from Central Eastern Europe with EGFR-Mutated Advanced Non-Small Cell Lung Cancer: A Retrospective Chart Review Study (REFLECT). Curr Oncol. 2022 Aug 17;29(8):5833-5845. doi: 10.3390/curroncol29080460.
Lampaki S, Mountzios G, Georgoulias V, Rapti A, Xanthakis I, Baka S, Mavroudis D, Samantas E, Athanasiadis E, Zagouri F, Charpidou A, Somarakis A, Papista C, Nikolaou A, Anastasopoulou E, Paparepa Z, Syrigos KN. Real-world management patterns in EGFR-mutant advanced non-small-cell lung cancer before first-line adoption of osimertinib: the REFLECT study in Greece. Future Oncol. 2022 Sep;18(28):3151-3164. doi: 10.2217/fon-2022-0386. Epub 2022 Aug 5.
Related Links
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Other Identifiers
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D5162R00009
Identifier Type: -
Identifier Source: org_study_id