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NCT Number: NCT06467383

A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced

This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).

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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 NSCLC NSCLC, Stage I NSCLC, Stage III 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

IRCCS Casa di sollievo dalla sofferenza, San Giovanni Rotondo, FG, Italy

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About this study

Due to heterogeneity of patients with stage I-III Non Small Cell Lung Cancer (NSCLC), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. Consequently, the choice of local treatment modality can vary across countries and centers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021
  • Adult patients (aged ≥ 18 years) at the moment of diagnosis
  • Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.

Exclusion criteria

  • Patients without availability of medical charts or information required
  • Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Treatment and study plan

Primary outcomes

  1. NSCLC treatment approaches in Real-World practice

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Percentage of patients undergoing to:

    • surgical resection of the lung cancer with curative intent;
    • definitive (chemo)radiotherapy (defined as any regimen of chemotherapy administered with concurrent radiotherapy)
    • neoadjuvant treatment (4 cycles) before surgery
    • adjuvant treatments (4 cycles) after surgery

  2. Percentage of patients discusses in multidisciplinary team

    Time frame: Restrospective data capture from January 2018 to January 2021

    Multidisciplinary team defined as the involvement of radiotherapy unit, pneumology and/or interventional pneumology unit in patient discussion.

  3. Healthcare resource utilization aof different therapeutic approaches

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Healthcare resources used to manage the patients will be described in terms of lab tests and/or outpatient visits and/or drug therapy and/or diagnostic tests.

  4. Direct medical costs of different therapeutic approaches

    Time frame: Restrospective data capture from January 2018 to January 2021.

    The cost of the therapeutic approach (cost of illness) will be estimated through an activity-based costing (ABC) technique which allows to calculate the full cost of a service by measuring the cost of each individual activity/resource related to it.

Secondary outcomes

  1. NSCLC treatments timeline in Real-World practice

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Median Time from:

    • diagnosis/multidisciplinary referral to surgery or start of radioterapy
    • surgery/completion of Radiotherapy to satrt of adjiuvant treatmen

Other outcomes

  1. Biomarkers profile evaluation at NSCLC diagnosis

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Percentage of PD-L1, EGFR/ALK, KRAS test performed along with results

  2. PD-L1 Biomarker profile evaluation at NSCLC diagnosis

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Percentage of PD-L1 test performed along with results

  3. EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Percentage of EGFR/ALK test performed along with results

  4. KRAS Biomarkers profile evaluation at NSCLC diagnosis

    Time frame: Restrospective data capture from January 2018 to January 2021.

    Percentage of KRAS test performed along with result

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Righi, PM

CONTACT

[email protected]

+39 051 5878211

Sponsors and collaborators

Lead sponsor

MSD Italia S.r.l.

Industry

Collaborators

  • YGHEA, CRO Division of Ecol Studio spa

Registry information

Acronym: Key-Early

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2024
Registry last updated
Jan 14, 2025

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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