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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT06039683
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Inclusion Criteria:<br><br>For inclusion in the study, all the following inclusion criteria must be fulfilled:<br><br> 1. Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR<br> mutation.<br><br> 2. Age 18 or older at index date (specific age may vary according to country-specific<br> guidelines)<br><br> 3. Treated in the first line with Osimertinib from (April 1st, 2018, until December<br> 31st, 2021).<br><br> 4. Medical records available at the participating site reflect at least 9 months of<br> follow-up from the index date (unless the patient died within the first 9 months of<br> diagnosis).<br><br>Note: specific databases may have additional inclusion criteria which will be detailed in<br>country-specific protocol adaptations and statistical analysis plans (SAPs).<br><br>Exclusion Criteria:<br><br>Subjects are not eligible for this study if they fulfil any of the following exclusion<br>criteria:<br><br> 1. Failure to meet one or more of the inclusion criteria.<br><br> 2. Patients who received curative CRT within 3 months and/or any first-line systemic<br> anti-cancer therapies (SACT) for advanced/metastatic NSCLC for >28 days prior to<br> Osimertinib start.<br><br> 3. Patients who have prior exposure of I/O therapy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe treatments and sequencing after treatment with first line Osimertinib.;To describe real world time to the next treatment or death (rwTTNTD).