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

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

Inclusion criteria

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 criteria

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.