Clinical trial NCT03959137: BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IV Non-small Cell Lung Cancer
Keywords: Treatment choice
Lead sponsor: MSD Belgium BVBA
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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 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.

Primary outcomes:
measure: The Study Outcome is Defined as the Systemic Treatment Choice.
timeFrame: during visits 1 and 2, up to approximately 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: UZA
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc UCL Bruxelles
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: CHIREC
city: Charleroi
country: Belgium
facility: CH de Charleroi
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: CH Jolimont
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: Az Groeninghe Kortrijk
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC Liège
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU de Liège
city: Namur
country: Belgium
facility: CHU UCL Namur, site Godinne
city: Ottignies
country: Belgium
facility: Clinique St-Pierre Ottignies
city: Roeselare
country: Belgium
facility: AZ Delta
city: Saint-Nicolas
country: Belgium
facility: AZ St Nikolaas
city: Sint-Truiden
country: Belgium
facility: St Trudo Ziekenhuis
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
References: