BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium (BEPACT- Lung)

BEPACT Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium: A Cross-sectional Study

The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years.

New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics.

The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.

Study Overview

• Status: Completed
• Conditions: Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Other: None - Common practice

Detailed Description

This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV non small cell lung cancer (NSCLC) selected for systemic treatment or best supportive care will be included in the trial at the time the patient signed the informed consent form (ICF). Patients that were selected for systemic treatment, should have received at least their first dose and a maximum of one cycle of the same treatment.

The pneumo-oncologist that treats the patient will fill in the CRF, indicating the systemic treatment option and the link with the variable categories that impacted the choice for a systemic treatment option.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • ZNA Middelheim
  • Antwerpen, Belgium
    • UZA
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Brussel, Belgium
    • UZ Brussel
  • Brussels, Belgium
    • Cliniques Universitaires Saint-Luc UCL Bruxelles
  • Bruxelles, Belgium
    • CHIREC
  • Charleroi, Belgium
    • CH de Charleroi
  • Gent, Belgium
    • UZ Gent
  • Haine-Saint-Paul, Belgium
    • CH Jolimont
  • Hasselt, Belgium
    • Jessa Ziekenhuis
  • Kortrijk, Belgium
    • Az Groeninghe Kortrijk
  • Leuven, Belgium
    • UZ Leuven
  • Liège, Belgium
    • CHU de Liège
  • Liège, Belgium
    • CHR Citadelle
  • Liège, Belgium
    • CHC Liege
  • Namur, Belgium
    • CHU UCL Namur, site Godinne
  • Ottignies, Belgium
    • Clinique St-Pierre Ottignies
  • Roeselare, Belgium
    • AZ Delta
  • Saint-Nicolas, Belgium
    • AZ St Nikolaas
  • Sint-Truiden, Belgium
    • St Trudo Ziekenhuis
  • Turnhout, Belgium
    • AZ Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At least 200 stage IV non-small cell lung cancer (NSCLC)subjects treated in approximately 20 Belgian hospitals starting first-line treatment or best supportive care will be enrolled in line with inclusion and exclusion criteria. Assuming that three stage IV NSCLC subjects can be recruited per month per site, enrollment period has been set to 5 months. Only a maximum of 10% of subjects can be enrolled by one site.

Description

Inclusion Criteria:

• Have voluntarily agreed to participate by giving written informed consent/assent for the trial.
• Have a histologically or cytologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) on first-line (1L) systemic treatment.
• Have received at least their first dose of the selected systemic treatment and a maximum of 1 cycle of the same treatment. Patients that were selected to receive best supportive care will not have to comply to this inclusion criterion.
• Be ≥ 18 years of age on day of signing informed consent.

Exclusion Criteria:

• Has received prior systemic treatment for their metastatic non-small cell lung cancer (NSCLC) before the first dose of trial treatment. However, subjects who received adjuvant or neoadjuvant therapy during an earlier stage of their disease, but evolved to stage IV, are eligible.
• Tyrosine kinase inhibitor (TKI) selected as first-line systemic treatment.
• Is participating in an interventional trial or medical need program.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary study group; Stage IV untreated NSCLC	Other: None - Common practice; None - Common practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Study Outcome is Defined as the Systemic Treatment Choice.	Systemic treatment choices are defined as : Chemotherapy (chemo); Immunotherapy (IO); immuno combined therapies (IO+IO); IO+chemo; IO+bevacizumab+chemo (IO+bev+chemo); best supportive care (BSC). There is no exposure in this study.	during visits 1 and 2, up to approximately 3 weeks

Collaborators and Investigators

• Sponsor: MSD Belgium BVBA

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Treatment choice
• 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: VEAP7678

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