Carcinoma, Non-Small-Cell LungTREASURENCT06039683
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
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 7 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 54 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 31 Dec 2022to 4 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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."
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Saudi Arabia3 sites
Research Site
Dammam
Research Site
Jeddah
Research Site
Riyadh
United Arab Emirates2 sites
Research Site
Abu Dhabi
Research Site
Al Ain City
About this study
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
Read the 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
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1st April 2018 till December 31st, 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start31 Dec 2022
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039683
- Sponsor's protocol ID
- D5161R00045
- Acronym
- TREASURE
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039683
- Acronym / sponsor ID
- TREASURE / D5161R00045
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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."
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe treatments and sequencing after treatment with first line Osimertinib.
Time frame: 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).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Redacted CSR-Synopsis\_version1.0Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Saudi Arabia, United Arab Emirates, Kuwait, Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe treatments and sequencing after treatment with first line Osimertinib. (time frame: 1st April 2018 till December 31st, 2021.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.