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

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ClinicalTrials.gov Identifier: NCT03959137
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
MSD Belgium BVBA

Brief Summary:

The treatment landscape of metastatic 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 NSCLC patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.


Condition or disease Intervention/treatment
Stage IV Non-small Cell Lung Cancer Other: None - Common practice

Detailed Description:

This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BEPACT Lung: Impact of Patient Characteristics on Pneumo-oncologists NSCLC Systemic Treatment Decision in Belgium: A Cross-sectional Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The study outcome is defined as the systemic treatment choice. [ Time Frame: Target 4 months, ]

    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At least 200 stage IV 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 4 months. Only a maximum of 10% of subjects can be enrolled by one site.
Criteria

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 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 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.
  • TKI selected as first-line systemic treatment.
  • Is participating in an interventional trial or medical need program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959137


Contacts
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Contact: Hermine J Leroi 32495582022 hermine.leroi@merck.com
Contact: Mathias Schifflers 32477982376 mathias.schifflers@merck.com

Sponsors and Collaborators
MSD Belgium BVBA

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Responsible Party: MSD Belgium BVBA
ClinicalTrials.gov Identifier: NCT03959137     History of Changes
Other Study ID Numbers: VEAP7678
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MSD Belgium BVBA:
Treatment choice
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases