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

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

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

Study Timeline

• Study Start: 2022-12-31
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-15
• Primary Completion: 2024-07-04
• Study Completion: 2024-07-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

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

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.

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.	1st April 2018 till December 31st, 2021.	Treatments and sequencing after treatment with first line Osimertinib - data on all subsequent lines of treatment, duration and dose changes will be collected until death or last contact or interim data cut-off/end of study period along with disease progression and outcome on the respective line of treatment
To describe real world time to the next treatment or death (rwTTNTD).	1st April 2018 till December 31st, 2021.	rwTTNTD, defined as the time in days from and inclusive of the index date until the start date of the next systemic therapy line or death from any cause (in absence of next systemic therapy line). Patients who do not receive a subsequent systemic therapy line or die during the study observation period will have TTNTD right censored at the earliest date of last contact or interim data cut-off date/end of the study period.

Trial Locations

Locations (1)

Research Site; 🇦🇪 Al Ain, United Arab Emirates