Non-small Cell Lung CancerTHASSOS-INTLNCT04808050
Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 25 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 748 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 3 Nov 2021to 31 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
India9 sites
Research Site
Bangalore, 560017
Research Site
Delhi, 110005
Research Site
Faridabad, 121001
Research Site
Howrah, Kolkata, India, 711103
Research Site
Kolkata, 700160
Research Site
Mumbai, 400012
Research Site
Mumbai, 400036
Research Site
Mumbai, 400615
Research Site
New Delhi, 110017
Turkey (Türkiye)7 sites
Research Site
Adana
Research Site
Ankara
Research Site
Antalya
Research Site
Diyarbakır
Research Site
Istanbul
Research Site
Izmir
Research Site
Samsun
Australia3 sites
Research Site
Brisbane, Queensland
Research Site
Perth, Western Australia
Research Site
Sydney, New South Wales
United Arab Emirates1 site
Research Site
Alain, United Arab Emirates
About this study
Official 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
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.
Read the detailed description
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. This study will also determine the prevalence of EGFR mutations and PD-L1 expression, and the clinical outcomes as per the treatment patterns and clinico-pathological staging. Data will be collected retrospectively from the patients' medical records from the date of initial diagnosis of early-stage NSCLC (index date) to the end of follow up ie, until death, the last medical record entry, or date of data extraction, whichever is the earliest. The data on treatment modalities, sociodemographic, clinico-pathological characteristics, and exposure and outcome variables (ie, medical and treatment history, disease staging, biomarker assessments, radiological findings, concomitant medications, survival), factor(s) for prescribing neo-adjuvant and/or adjuvant treatment and reason(s) for discontinuation will be extracted from patients' medical records.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Resectable Early-stage (IA to IIIB)
- 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.
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
Measured: 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
Measured: 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.
Measured: 3 Years
Secondary outcomes (9)
Demographic characteristics
Demographic overall and as per treatment modalities ; underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities): age, gender, ethnicity, body mass index, smoking status, geographical location
Measured: 3 Years
Eastern Cooperative Oncology performance status Group characteristics
Proportion and classification of Eastern Cooperative Oncology Group (ECOG) performance status Clinical-pathological characteristics overall and as per treatment modalities ; underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities
Measured: 3 Years
Histological type
Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)
Measured: 3 Yewars
Clinical-pathological Tumor stage
Tumor Staging as per seventh edition AJCC (IA, IB, IIA, IIB, IIIA, IIIB) with lymph node metastasis status (N0, N1, and N2)
Measured: 3 Years
TNM staging at index diagnosis
TNM staging at index diagnosis
Measured: 1 Month
Genetic alterations
Other genetic alterations(anaplastic lymphoma kinase [ALK], Kirsten rat sarcoma viral oncogene [KRAS], B-Raf proto-oncogene [BRAF], rearranged during transfection [RET], mesenchymal-to-epithelial transition factor [MET], human epidermal growth factor receptor 2 [HER2], ROS proto-oncogene 1 receptor tyrosine kinase [ROS1], and tumour protein 53 [TP53]
Measured: 3 Years
Survival rates at pre-defined landmark timepoints (other than 3-year)
Survival rates at pre-defined landmark timepoints (other than 3-year) for each of the treatment modality; ho underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies
Measured: 1 Years
Prevalence of EGFR mutations
Proportion of patients with EGFR mutation-positive status
Measured: 3 Years
Prevalence of PD-L1 expression
Proportion of patients with PD-L1 positivity at various cut-off points (<1%, ≥1% to <25%, ≥25% to <50%, and ≥50%)
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start3 Nov 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808050
- Sponsor's protocol ID
- D133FR00169
- Acronym
- THASSOS-INTL
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 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 the Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage (IA to IIIB) Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04808050
- Acronym / sponsor ID
- THASSOS-INTL / D133FR00169
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Resectable Early-stage (IA to IIIB)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Mar 2021 (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.
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.
Detailed description
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. This study will also determine the prevalence of EGFR mutations and PD-L1 expression, and the clinical outcomes as per the treatment patterns and clinico-pathological staging. Data will be collected retrospectively from the patients' medical records from the date of initial diagnosis of early-stage NSCLC (index date) to the end of follow up ie, until death, the last medical record entry, or date of data extraction, whichever is the earliest. The data on treatment modalities, sociodemographic, clinico-pathological characteristics, and exposure and outcome variables (ie, medical and treatment history, disease staging, biomarker assessments, radiological findings, concomitant medications, survival), factor(s) for prescribing neo-adjuvant and/or adjuvant treatment and reason(s) for discontinuation will be extracted from patients' medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
Proportion of patients per treatment modalities
Time frame: 3 Years
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
Duration of treatment
Time frame: 3 years
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
Survival rate
Time frame: 3 Years
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.
9 secondary outcomes
Demographic characteristics
Time frame: 3 Years
Eastern Cooperative Oncology performance status Group characteristics
Time frame: 3 Years
Histological type
Time frame: 3 Yewars
Clinical-pathological Tumor stage
Time frame: 3 Years
TNM staging at index diagnosis
Time frame: 1 Month
Genetic alterations
Time frame: 3 Years
Survival rates at pre-defined landmark timepoints (other than 3-year)
Time frame: 1 Years
Prevalence of EGFR mutations
Time frame: 3 Years
Prevalence of PD-L1 expression
Time frame: 3 Years
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 21 Feb 2024.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 25 sites in 7 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 3 inclusion and 3 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in India, Turkey (Türkiye), Australia, Egypt, Hong Kong and 2 more countries. 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?
Proportion of patients per treatment modalities (time frame: 3 Years). The study lists 3 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 21 Feb 2024.