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 (TREASURE)

AstraZeneca

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Industry

Identifiers

NCT06039683

D5161R00045

Details and patient eligibility

About

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

Full 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 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

Enrollment: 54 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

For inclusion in the study, all the following inclusion criteria must be fulfilled:

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).

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:

1. Failure to meet one or more of the inclusion criteria.
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.