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

Completed
Conditions
Stage IV Non-small Cell Lung Cancer
Interventions
Other: None - Common practice
Registration Number
NCT03959137
Lead Sponsor
MSD Belgium BVBA
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
215
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 β‰₯ 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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Primary study groupNone - Common practiceStage IV untreated NSCLC
Primary Outcome Measures
NameTimeMethod
The Study Outcome is Defined as the Systemic Treatment Choice.during visits 1 and 2, up to approximately 3 weeks

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (21)

Imelda Ziekenhuis

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Bonheiden, Belgium

St Trudo Ziekenhuis

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Sint-Truiden, Belgium

CH de Charleroi

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Charleroi, Belgium

CH Jolimont

πŸ‡§πŸ‡ͺ

Haine-Saint-Paul, Belgium

Jessa Ziekenhuis

πŸ‡§πŸ‡ͺ

Hasselt, Belgium

UZ Gent

πŸ‡§πŸ‡ͺ

Gent, Belgium

Az Groeninghe Kortrijk

πŸ‡§πŸ‡ͺ

Kortrijk, Belgium

CHU UCL Namur, site Godinne

πŸ‡§πŸ‡ͺ

Namur, Belgium

Clinique St-Pierre Ottignies

πŸ‡§πŸ‡ͺ

Ottignies, Belgium

AZ Turnhout

πŸ‡§πŸ‡ͺ

Turnhout, Belgium

CHU de Liège

πŸ‡§πŸ‡ͺ

Liège, Belgium

AZ Delta

πŸ‡§πŸ‡ͺ

Roeselare, Belgium

Cliniques Universitaires Saint-Luc UCL Bruxelles

πŸ‡§πŸ‡ͺ

Brussels, Belgium

UZ Leuven

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Leuven, Belgium

CHR Citadelle

πŸ‡§πŸ‡ͺ

Liège, Belgium

AZ St Nikolaas

πŸ‡§πŸ‡ͺ

Saint-Nicolas, Belgium

UZA

πŸ‡§πŸ‡ͺ

Antwerpen, Belgium

ZNA Middelheim

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Antwerpen, Belgium

UZ Brussel

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Brussel, Belgium

CHIREC

πŸ‡§πŸ‡ͺ

Bruxelles, Belgium

CHC Liège

πŸ‡§πŸ‡ͺ

Liège, Belgium

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