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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

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 Type: Observational
• Enrollment (Actual): 748

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Research Site
  • Queensland
    • Brisbane, Queensland, Australia
      • Research Site
  • Western Australia
    • Perth, Western Australia, Australia
      • Research Site
• Egypt
  • Alexandria, Egypt
    • Research Site
  • Cairo, Egypt
    • Research Site
  • Sohag, Egypt
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
• India
  • Bangalore, India, 560017
    • Research Site
  • Delhi, India, 110005
    • Research Site
  • Faridabad, India, 121001
    • Research Site
  • Howrah, Kolkata, India, 711103
    • Research Site
  • Kolkata, India, 700160
    • Research Site
  • Mumbai, India, 400012
    • Research Site
  • Mumbai, India, 400036
    • Research Site
  • Mumbai, India, 400615
    • Research Site
  • New Delhi, India, 110017
    • Research Site
• Kuwait
  • Kuwait City, Kuwait
    • Research Site
• Turkey
  • 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, Turkey
    • Research Site
• United Arab Emirates
  • Alain, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Histological type	Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)	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)	3 Years
TNM staging at index diagnosis	TNM staging at index diagnosis	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]	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	1 Years
Prevalence of EGFR mutations	Proportion of patients with EGFR mutation-positive status	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%)	3 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Resectable Early-stage (IA to IIIB)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D133FR00169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.

IPD Sharing 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:

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No