Clinical trial NCT06039683: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. 18 years or older patients had pathological/molecular confirmed advanced/metastatic EGFRm NSCLC (including both sensitized and uncommon mutations), with or without previous adjuvant/neoadjuvant chemotherapy, initiating first-line Osimertinib treatment between 1st April 2018 till December 31st, 2021.
2. Patients who are treated with short doses of chemotherapy or any other targeted therapy for up to 28 days before Osimertinib initiation will still be considered "firstline Osimertinib patients."

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

Eligibility criteria: 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.

Primary outcomes:
measure: To describe treatments and sequencing after treatment with first line Osimertinib.
timeFrame: 1st April 2018 till December 31st, 2021.
measure: To describe real world time to the next treatment or death (rwTTNTD).
timeFrame: 1st April 2018 till December 31st, 2021.
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Dammam
country: Saudi Arabia
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Al Ain
country: United Arab Emirates
facility: Research Site
Study officials:
References: