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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

NCT ID: NCT06039683

Last Updated: 2024-11-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-07-04

Brief Summary

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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 Metastatic NSCLC harboring EGFR-activating mutations in the GCC Region

Detailed Description

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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 outcomes in the real-world setting and determine the characteristics of long-term survivors in the real world. It will also be important to determine the subsequent treatment pathways of patients who progress on treatment with Osimertinib

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR mutation.
2. Age 18 or older at index date (specific age may vary according to country-specific guidelines)
3. Treated in the first line with Osimertinib from (April 1st, 2018, until December 31st, 2021).
4. 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).


2. 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.
3. Patients who have prior exposure of I/O therapy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Kuwait City, , Kuwait

Site Status

Research Site

Doha, , Qatar

Site Status

Research Site

Dammam, , Saudi Arabia

Site Status

Research Site

Jeddah, , Saudi Arabia

Site Status

Research Site

Riyadh, , Saudi Arabia

Site Status

Research Site

Abu Dhabi, , United Arab Emirates

Site Status

Research Site

Al Ain City, , United Arab Emirates

Site Status

Countries

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Kuwait Qatar Saudi Arabia United Arab Emirates

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5161R00045&attachmentIdentifier=6a15f98c-0dec-4488-ac6e-f72bb83829dc&fileName=Treasure_study_-Redacted_CSR-Synopsis_version1.0.pdf&versionIdentifier=

Redacted CSR-Synopsis\_version1.0

Other Identifiers

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D5161R00045

Identifier Type: -

Identifier Source: org_study_id