Status:
COMPLETED
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC Region
Lead Sponsor:
AstraZeneca
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
Brief Summary
A Multicountry, Multicenter, Non-interventional, Retrospective Study to determine Real-world treatment patterns and associated outcomes after FIRST LINE Osimertinib in patients with advanced and Metas...
Detailed Description
Osimertinib has demonstrated superior PFS compared to firstgeneration EGFR-TKIs (erlotinib and gefitinib) in the first line setting in clinical trials. There remains a need to consider clinical outcom...
Eligibility Criteria
Inclusion
- For inclusion in the study, all the following inclusion criteria must be fulfilled:
- Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR mutation.
- Age 18 or older at index date (specific age may vary according to country-specific guidelines)
- Treated in the first line with Osimertinib from (April 1st, 2018, until December 31st, 2021).
- Medical records available at the participating site reflect at least 9 months of follow-up from the index date (unless the patient died within the first 9 months of diagnosis).
- Note: specific databases may have additional inclusion criteria which will be detailed in country-specific protocol adaptations and statistical analysis plans (SAPs).
Exclusion
- Subjects are not eligible for this study if they fulfil any of the following exclusion criteria:
- Failure to meet one or more of the inclusion criteria.
- Patients who received curative CRT within 3 months and/or any first-line systemic anti-cancer therapies (SACT) for advanced/metastatic NSCLC for \>28 days prior to Osimertinib start.
- Patients who have prior exposure of I/O therapy.
Key Trial Info
Start Date :
December 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 4 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06039683
Start Date
December 31 2022
End Date
July 4 2024
Last Update
November 29 2024
Active Locations (7)
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1
Research Site
Kuwait City, Kuwait
2
Research Site
Doha, Qatar
3
Research Site
Dammam, Saudi Arabia
4
Research Site
Jeddah, Saudi Arabia