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

January 13, 2025 updated by: MSD Italia S.r.l.
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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Brescia, Italy
        • Not yet recruiting
        • Asst Degli Spedali Civili Di Brescia
        • Contact:
          • Salvatore Grisanti, MD
      • Campobasso, Italy
        • Not yet recruiting
        • Gemelli Molise
        • Contact:
          • Andrea Mancuso Petricca, MD
      • Catania, Italy
        • Not yet recruiting
        • Humanitas Istituto Clinico Catanese
        • Contact:
          • Michele Caruso, MD
      • Catania, Italy
        • Not yet recruiting
        • Policlinico Rodolico
        • Contact:
          • Hector Soto Parra, MD
      • Firenze, Italy
        • Recruiting
        • AOU Careggi
        • Contact:
          • Lorenzo Antonuzzo, MD
      • Genova, Italy
        • Recruiting
        • IRCCS Policlinico S. Martino
        • Contact:
          • Carlo Genova, MD
      • Messina, Italy
        • Not yet recruiting
        • AO Papardo
        • Contact:
          • Alessandro Russo, MD
      • Milano, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Giulia Veronesi, MD
      • Milano, Italy
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
          • Sabrina Rossi, MD
      • Milano, Italy
        • Not yet recruiting
        • Istituto Nazionale dei Tumori - Fondazione IRCCS
        • Contact:
          • Giuseppe Lo Russo, MD
      • Napoli, Italy
        • Not yet recruiting
        • AOU dei Colli - Monaldi
        • Contact:
          • Danilo Rocco, MD
      • Napoli, Italy
        • Recruiting
        • Aou Vanvitelli
        • Contact:
          • Floriana Morgillo, MD
      • Novara, Italy
        • Recruiting
        • A.O.U. Maggiore della Carita di Novara
        • Contact:
          • Gloria Borra, MD
      • Padova, Italy
        • Not yet recruiting
        • IOV - Istituto Oncologico Veneto - IRCCS
        • Contact:
          • Laura Bonanno, MD
      • Palermo, Italy
        • Not yet recruiting
        • AOUP Policlinico Giaccone
        • Contact:
          • Antonio Russo, MD
      • Perugia, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia
        • Contact:
          • Maria Francesca Currà
      • Pistoia, Italy
        • Recruiting
        • Azienda USL Toscana Centro - Ospedale san Jacopo
        • Contact:
          • Mauro Iannopollo, MD
      • Pordenone, Italy
        • Not yet recruiting
        • Centro di Riferimento Oncologico IRCCS
        • Contact:
          • Brigida Stanzione, MD
      • Potenza, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Regionale San Carlo di Potenza
        • Contact:
          • Domenico Bilancia, MD
      • Ravenna, Italy
        • Not yet recruiting
        • AUSL Romagna Ospedale Santa Maria delle Croci Ravenna
        • Contact:
          • Chiara Bennati, MD
      • Reggio Emilia, Italy
        • Not yet recruiting
        • IRCCS AUSL Reggio Emilia
        • Contact:
          • Francesca Zanelli, MD
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario "A. Gemelli"
        • Contact:
          • Emilio Bria, MD
      • Varese, Italy
        • Not yet recruiting
        • ASST dei Sette Laghi
        • Contact:
          • Francesco Grossi, MD
      • Verona, Italy
        • Not yet recruiting
        • AOUI Verona
        • Contact:
          • Sara Pilotto, MD
    • FG
      • San Giovanni Rotondo, FG, Italy
        • Not yet recruiting
        • IRCCS Casa di sollievo dalla sofferenza
        • Contact:
          • Evaristo Maiello, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients with early stage and locally advanced NSCLC (stage I-III) who had completed curative treatment planning and subsequent at least 18-months follow-up between January 2018 and January 2021.

Description

Inclusion Criteria:

  1. 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
  2. Adult patients (aged ≥ 18 years) at the moment of diagnosis
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NSCLC treatment approaches in Real-World practice
Time Frame: Restrospective data capture from January 2018 to January 2021.

Percentage of patients undergoing to:

  1. surgical resection of the lung cancer with curative intent;
  2. definitive (chemo)radiotherapy (defined as any regimen of chemotherapy administered with concurrent radiotherapy)
  3. neoadjuvant treatment (4 cycles) before surgery
  4. adjuvant treatments (4 cycles) after surgery
Restrospective data capture from January 2018 to January 2021.
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.
Restrospective data capture from January 2018 to January 2021
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.
Restrospective data capture from January 2018 to January 2021.
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.
Restrospective data capture from January 2018 to January 2021.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NSCLC treatments timeline in Real-World practice
Time Frame: Restrospective data capture from January 2018 to January 2021.

Median Time from:

  1. diagnosis/multidisciplinary referral to surgery or start of radioterapy
  2. surgery/completion of Radiotherapy to satrt of adjiuvant treatmen
Restrospective data capture from January 2018 to January 2021.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Restrospective data capture from January 2018 to January 2021.
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
Restrospective data capture from January 2018 to January 2021.
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
Restrospective data capture from January 2018 to January 2021.
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
Restrospective data capture from January 2018 to January 2021.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MSD Italia S.r.l.

Collaborators

YGHEA, CRO Division of Ecol Studio spa

Investigators

  • Study Chair: Giada Iuliano, MD, MSD Italia srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

June 24, 2025

Study Completion (Estimated)

June 24, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS009903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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