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

Stage IV Non-small Cell Lung Cancer Clinical Trial

— BEPACT- Lung  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959137
• Other study ID #: VEAP7678
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2021
• Source: MSD Belgium BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

Other:
• None - Common practice
None - Common practice

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MSD Belgium BVBA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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