A Multicountry, Multicentre, Non-interventional, Retrospe... | NCT06039683

Studies
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

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 29, 2024Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Not provided

Countries

Kuwait
Qatar
Saudi Arabia
United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2022Actual

Primary Completion Date

Jul 4, 2024Actual

Completion Date

Jul 4, 2024Actual

First Submitted Date

Sep 6, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Nov 29, 2024Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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.
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."

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Kuwait City			Kuwait
Research Site

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases