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NCT Number: NCT04808050

Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. Demographic characteristics

    Time frame: 3 Years

    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

  2. Eastern Cooperative Oncology performance status Group characteristics

    Time frame: 3 Years

    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. Histological type

    Time frame: 3 Yewars

    Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)

  4. Clinical-pathological Tumor stage

    Time frame: 3 Years

    Tumor Staging as per seventh edition AJCC (IA, IB, IIA, IIB, IIIA, IIIB) with lymph node metastasis status (N0, N1, and N2)

  5. TNM staging at index diagnosis

    Time frame: 1 Month

    TNM staging at index diagnosis

  6. Genetic alterations

    Time frame: 3 Years

    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]

  7. Survival rates at pre-defined landmark timepoints (other than 3-year)

    Time frame: 1 Years

    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

  8. Prevalence of EGFR mutations

    Time frame: 3 Years

    Proportion of patients with EGFR mutation-positive status

  9. Prevalence of PD-L1 expression

    Time frame: 3 Years

    Proportion of patients with PD-L1 positivity at various cut-off points (<1%, ≥1% to <25%, ≥25% to <50%, and ≥50%)

Other outcomes

  1. Effectiveness outcomes rwDFS defined as time from the date of surgery to recurrence or death

    Time frame: 3 Years

    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

  2. Effectiveness outcomes rwEFS rate at predefined landmark timepoints

    Time frame: 3 Years

    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. Effectiveness outcomes rwPFS defined as time from local or distant relapse to disease progression or death

    Time frame: 3 Years

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: THASSOS-INTL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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