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

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: Not yet recruiting
• Conditions: NSCLC; Non-small Cell Lung Cancer; NSCLC, Stage III; NSCLC, Stage I

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

• Study Contact: Name: Daniele Righi Project Manager; Phone Number: +39 051 5878211; Email: d.righi@yghea.it

Participation Criteria

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 & privacy Form (ICF), if applicable (see section 5.1.1 for details on consent collection for Deceased patients and Untraceable patients).

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients undergoing surgery for early stage or locally advanced NSCLC	Curative surgery, defined as surgical resection of the lung cancer (i.e. lobectomy, pneumonectomy, segmental resection, or other) with curative intent	Restrospective data capture from January 2018 to January 2021.
Percentage of patients discusses in multidisciplinary team		Restrospective data capture from January 2018 to January 2021
Percentage of patient receiving neoadjuvant and/or adjuvant treatment and percentage of patient undergoing definitive (chemo)radiotherapy	Concurrent (or concomitant) chemoradiotherapy, defined as any regimen of chemotherapy administered with concurrent radiotherapy. Sequential chemoradiotherapy, defined either as any regimen of chemotherapy followed by at least one session of radiotherapy, or at least one radiotherapy course followed by at least one cycle of chemotherapy; in order to be defined as sequential chemoradiotherapy, tumor resection shall not be performed between chemotherapy and radiotherapy or vice versa.	Restrospective data capture from January 2018 to January 2021.
Healthcare resource utilization and direct medical costs on different therapeutic approach	Cost of illness, defined as the total key-resources cost for each patient (i.e. visits and other physician services including surgery and radiotherapy cost, hospitalization, diagnostic procedures and tests, routine laboratory, disease assessment, administered drugs)	Restrospective data capture from January 2018 to January 2021.

Collaborators and Investigators

• Sponsor: MSD Italia S.r.l.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2024
• Primary Completion (Estimated): June 19, 2025
• Study Completion (Estimated): June 19, 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): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: The KEY-EARLY study is an Italian observational multicenter retrospective cohort study on early stage and locally advanced NSCLC patients (stage I - III)
• 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: 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