Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer
THASSOS-INTL
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine the Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage (IA to IIIB) Non-small Cell Lung Cancer
1 other identifier
observational
748
7 countries
25
Brief Summary
This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020 The main objective of this study is to describe the treatment patterns and determine their associated 3-year survival rate according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB as per AJCC seventh edition) NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedFebruary 21, 2024
January 1, 2024
12 months
February 22, 2021
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of patients per treatment modalities
Proportion of patients, overall and as per clinical and pathologic staging (seventh edition of the tumour, nodes, metastases \[TNM\] classification for lung cancer \[AJCC\]) who underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities
3 Years
Duration of treatment
Duration of treatment for each treatment regimen in neo-adjuvant and adjuvant treatment settings, dose of each agent, and reason(s) for stopping treatment in each setting
3 years
Survival rate
Survival rate (overall, and as per clinical and pathologic staging) defined as percentage of patients, confirmed to be alive at 3 years from the index date.
3 Years
Secondary Outcomes (9)
Demographic characteristics
3 Years
Eastern Cooperative Oncology performance status Group characteristics
3 Years
Histological type
3 Yewars
Clinical-pathological Tumor stage
3 Years
TNM staging at index diagnosis
1 Month
- +4 more secondary outcomes
Other Outcomes (3)
Effectiveness outcomes rwDFS defined as time from the date of surgery to recurrence or death
3 Years
Effectiveness outcomes rwEFS rate at predefined landmark timepoints
3 Years
Effectiveness outcomes rwPFS defined as time from local or distant relapse to disease progression or death
3 Years
Eligibility Criteria
Patients who were diagnosed with primary stage IA to IIIB NSCLC between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020.
You may qualify if:
- Adult female and male patients aged ≥18 years or 'adults' according to age of majority as defined by the local regulations on index date
- Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable
- Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020, as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage \[IA to stage IIIB\] resectable NSCLC), unless patient died within 12 months of diagnosis.
You may not qualify if:
- Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
- Patients diagnosed with stage IV NSCLC
- Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Sydney, New South Wales, Australia
Research Site
Brisbane, Queensland, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Alexandria, Egypt
Research Site
Cairo, Egypt
Research Site
Sohag, Egypt
Research Site
Hong Kong, Hong Kong
Research Site
Howrah, Kolkata, India, 711103, India
Research Site
Bangalore, 560017, India
Research Site
Delhi, 110005, India
Research Site
Faridabad, 121001, India
Research Site
Kolkata, 700160, India
Research Site
Mumbai, 400012, India
Research Site
Mumbai, 400036, India
Research Site
Mumbai, 400615, India
Research Site
New Delhi, 110017, India
Research Site
Kuwait City, Kuwait
Research Site
Adana, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Diyarbakır, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Samsun, Turkey (Türkiye)
Research Site
Alain, United Arab Emirates, United Arab Emirates
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 19, 2021
Study Start
November 3, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
February 21, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. URL:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.