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

NCT06039683 | Completed

• 1 other identifier: D5161R00045
• Study Type: observational
• Target: 54
• Locations: 4 countries
• Sites: 7

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• To describe treatments and sequencing after treatment with first line Osimertinib.

  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

  1st April 2018 till December 31st, 2021.

• To describe real world time to the next treatment or death (rwTTNTD).

  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.

  1st April 2018 till December 31st, 2021.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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."

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Kuwait City, Kuwait

Location

Research Site

Doha, Qatar

Location

Research Site

Dammam, Saudi Arabia

Location

Research Site

Jeddah, Saudi Arabia

Location

Research Site

Riyadh, Saudi Arabia

Location

Research Site

Abu Dhabi, United Arab Emirates

Location

Research Site

Al Ain City, United Arab Emirates

Location

Related Links

• Redacted CSR-Synopsis\_version1.0

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: December 31, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

SA (3); AE (2); KU (1); QA (1)