Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— THASSOS-INTL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808050
• Other study ID #: D133FR00169
• Status: Completed
• Start date: November 3, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Perth	Western Australia
Australia	Research Site	Sydney	New South Wales
Egypt	Research Site	Alexandria
Egypt	Research Site	Cairo
Egypt	Research Site	Sohag
Hong Kong	Research Site	Hong Kong
India	Research Site	Bangalore
India	Research Site	Delhi
India	Research Site	Faridabad
India	Research Site	Howrah, Kolkata
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	Mumbai
India	Research Site	Mumbai
India	Research Site	New Delhi
Kuwait	Research Site	Kuwait City
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Samsun
United Arab Emirates	Research Site	Alain

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Egypt,  Hong Kong,  India,  Kuwait,  Turkey,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effectiveness outcomes rwDFS defined as time from the date of surgery to recurrence or death	Effectiveness outcomes will be determined for each treatment modality as; rwDFS defined as time from the date of surgery to recurrence or death due to any cause; rwDFS rate at predefined landmark timepoints (overall, per clinical, and pathologic staging) for evaluation of primary treatment	3 Years
Other	Effectiveness outcomes rwEFS rate at predefined landmark timepoints	Effectiveness outcomes will be determined for each treatment modality as; rwEFS rate at predefined landmark timepoints (overall, per clinical and pathologic staging) for evaluation of primary treatment	3 Years
Other	Effectiveness outcomes rwPFS defined as time from local or distant relapse to disease progression or death	Effectiveness outcomes will be determined for each treatment modality as; rwPFS defined as time from local or distant relapse to disease progression or death due to any cause for evaluation of subsequent treatment ie, first, second, and third LOTsa	3 Years
Primary	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
Primary	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
Primary	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	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	3 Years
Secondary	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	3 Years
Secondary	Histological type	Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)	3 Yewars
Secondary	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)	3 Years
Secondary	TNM staging at index diagnosis	TNM staging at index diagnosis	1 Month
Secondary	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]	3 Years
Secondary	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	1 Years
Secondary	Prevalence of EGFR mutations	Proportion of patients with EGFR mutation-positive status	3 Years
Secondary	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%)	3 Years

External Links

•   Redacted CSR synopsis