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

• 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.

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Study Start: 2019-06-03
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2021-01-21
• Status Verified: 2021-03
• Results First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Results First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

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 ≥ 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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (21)

UZA; 🇧🇪 Antwerpen, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Cliniques Universitaires Saint-Luc UCL Bruxelles; 🇧🇪 Brussels, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

CHIREC; 🇧🇪 Bruxelles, Belgium

CH de Charleroi; 🇧🇪 Charleroi, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

CH Jolimont; 🇧🇪 Haine-Saint-Paul, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

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