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

NCT03959137 | Completed Results

• 1 other identifier: VEAP7678
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Stage IV Non-small Cell Lung Cancer

Keywords

Treatment choice

Outcome Measures

Primary Outcomes (1)

• The Study Outcome is Defined as the Systemic Treatment Choice.

  Systemic treatment choices are defined as : 1. Chemotherapy (chemo) 2. Immunotherapy (IO) 3. immuno combined therapies (IO+IO) 4. IO+chemo 5. IO+bevacizumab+chemo (IO+bev+chemo) 6. best supportive care (BSC). There is no exposure in this study.

  during visits 1 and 2, up to approximately 3 weeks

Study Arms (1)

Primary study group

Stage IV untreated NSCLC

Other: None - Common practice

Interventions

None - Common practice OTHER

None - Common practice

Primary study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Be ≥ 18 years of age on day of signing informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MSD Belgium BVBA: lead

Study Sites (21)

UZA

Antwerp, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

CHIREC

Brussels, Belgium

Location

Cliniques Universitaires Saint-Luc UCL Bruxelles

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

CH de Charleroi

Charleroi, Belgium

Location

UZ Gent

Ghent, Belgium

Location

CH Jolimont

Haine-Saint-Paul, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Az Groeninghe Kortrijk

Kortrijk, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHC Liège

Liège, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

CHU de Liège

Liège, Belgium

Location

CHU UCL Namur, site Godinne

Namur, Belgium

Location

Clinique St-Pierre Ottignies

Ottignies, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

AZ St Nikolaas

Saint-Nicolas, Belgium

Location

St Trudo Ziekenhuis

Sint-Truiden, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The experiment is not interventional and cross sectional.

Results Point of Contact

• Title: Stephanie Coulon
• Organization: MSD Belgium

stephanie.coulon@merck.com

0032 485 461 467

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: June 3, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (21)