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

Recruiting

• Conditions: NSCLC; Non-small Cell Lung Cancer; NSCLC, Stage III; NSCLC, Stage I

• Registration Number: NCT06467383
• Lead Sponsor: MSD Italia S.r.l.

Brief Summary

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).

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 Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Study Start: 2024-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-06-24
• Study Completion: 2025-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NSCLC treatment approaches in Real-World practice	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
Percentage of patients discusses in multidisciplinary team	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.
Healthcare resource utilization aof different therapeutic approaches	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.
Direct medical costs of different therapeutic approaches	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 Outcome Measures

Name	Time	Method
NSCLC treatments timeline in Real-World practice	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

Trial Locations

Locations (25)

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

Gemelli Molise; 🇮🇹 Campobasso, Italy

AO Papardo; 🇮🇹 Messina, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy

Istituto Nazionale dei Tumori - Fondazione IRCCS; 🇮🇹 Milano, Italy

ASST degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Humanitas Istituto Clinico Catanese; 🇮🇹 Catania, Italy

Policlinico Rodolico; 🇮🇹 Catania, Italy

IRCCS Policlinico S. Martino; 🇮🇹 Genova, Italy

AOU Careggi; 🇮🇹 Firenze, Italy

Istituto Clinico Humanitas; 🇮🇹 Milano, Italy

AOU dei Colli - Monaldi; 🇮🇹 Napoli, Italy

AOU Vanvitelli; 🇮🇹 Napoli, Italy

A.O.U. Maggiore della Carità di Novara; 🇮🇹 Novara, Italy

IOV - Istituto Oncologico veneto - IRCCS; 🇮🇹 Padova, Italy

AOUP Policlinico Giaccone; 🇮🇹 Palermo, Italy

Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia; 🇮🇹 Perugia, Italy

Azienda USL Toscana Centro - Ospedale san Jacopo; 🇮🇹 Pistoia, Italy

Centro di Riferimento Oncologico IRCCS; 🇮🇹 Pordenone, Italy

Azienda Ospedaliera Regionale San Carlo di Potenza; 🇮🇹 Potenza, Italy

AUSL Romagna Ospedale Santa Maria delle Croci Ravenna; 🇮🇹 Ravenna, Italy

IRCCS AUSL Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Fondazione Policlinico Universitario "A. Gemelli"; 🇮🇹 Roma, Italy

ASST dei Sette Laghi; 🇮🇹 Varese, Italy

AOUI Verona; 🇮🇹 Verona, Italy