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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04808050




Registration number
NCT04808050
Ethics application status
Date submitted
22/02/2021
Date registered
19/03/2021

Titles & IDs
Public title
Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer
Scientific title
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
Secondary ID [1] 0 0
D133FR00169
Universal Trial Number (UTN)
Trial acronym
THASSOS-INTL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients per treatment modalities
Timepoint [1] 0 0
3 Years
Primary outcome [2] 0 0
Duration of treatment
Timepoint [2] 0 0
3 years
Primary outcome [3] 0 0
Survival rate
Timepoint [3] 0 0
3 Years
Secondary outcome [1] 0 0
Demographic characteristics
Timepoint [1] 0 0
3 Years
Secondary outcome [2] 0 0
Eastern Cooperative Oncology performance status Group characteristics
Timepoint [2] 0 0
3 Years
Secondary outcome [3] 0 0
Histological type
Timepoint [3] 0 0
3 Yewars
Secondary outcome [4] 0 0
Clinical-pathological Tumor stage
Timepoint [4] 0 0
3 Years
Secondary outcome [5] 0 0
TNM staging at index diagnosis
Timepoint [5] 0 0
1 Month
Secondary outcome [6] 0 0
Genetic alterations
Timepoint [6] 0 0
3 Years
Secondary outcome [7] 0 0
Survival rates at pre-defined landmark timepoints (other than 3-year)
Timepoint [7] 0 0
1 Years
Secondary outcome [8] 0 0
Prevalence of EGFR mutations
Timepoint [8] 0 0
3 Years
Secondary outcome [9] 0 0
Prevalence of PD-L1 expression
Timepoint [9] 0 0
3 Years

Eligibility
Key inclusion criteria
1. Adult female and male patients aged =18 years or 'adults' according to age of majority as defined by the local regulations on index date
2. 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
3. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Patients diagnosed with stage IV NSCLC
3. 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2022
Sample size
Target
Accrual to date
Final
748
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment hospital [2] 0 0
Research Site - Brisbane
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Egypt
State/province [1] 0 0
Alexandria
Country [2] 0 0
Egypt
State/province [2] 0 0
Cairo
Country [3] 0 0
Egypt
State/province [3] 0 0
Sohag
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Hong Kong
Country [5] 0 0
India
State/province [5] 0 0
Bangalore
Country [6] 0 0
India
State/province [6] 0 0
Delhi
Country [7] 0 0
India
State/province [7] 0 0
Faridabad
Country [8] 0 0
India
State/province [8] 0 0
Howrah, Kolkata
Country [9] 0 0
India
State/province [9] 0 0
Kolkata
Country [10] 0 0
India
State/province [10] 0 0
Mumbai
Country [11] 0 0
India
State/province [11] 0 0
New Delhi
Country [12] 0 0
Kuwait
State/province [12] 0 0
Kuwait City
Country [13] 0 0
Turkey
State/province [13] 0 0
Adana
Country [14] 0 0
Turkey
State/province [14] 0 0
Ankara
Country [15] 0 0
Turkey
State/province [15] 0 0
Antalya
Country [16] 0 0
Turkey
State/province [16] 0 0
Diyarbakir
Country [17] 0 0
Turkey
State/province [17] 0 0
Istanbul
Country [18] 0 0
Turkey
State/province [18] 0 0
Izmir
Country [19] 0 0
Turkey
State/province [19] 0 0
Samsun
Country [20] 0 0
United Arab Emirates
State/province [20] 0 0
Alain

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
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:
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04808050