Stage IV Non-small Cell Lung CancerBEPACT- LungNCT03959137

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

An observational study of Stage IV Non-small Cell Lung Cancer, run by MSD Belgium BVBA at 21 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Stage IV Non-small Cell Lung Cancer
What is being tested?: None - Common practice
Type of treatment: Injection or infusion
How many people: 215 participants
Where: 21 sitesBelgium
Study dates: 3 Jun 2019to 31 Oct 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Belgium21 sites

UZA
Antwerp
ZNA Middelheim
Antwerp
Imelda Ziekenhuis
Bonheiden
CHIREC
Brussels
Cliniques Universitaires Saint-Luc UCL Bruxelles
Brussels
UZ Brussel
Brussels
CH de Charleroi
Charleroi
UZ Gent
Ghent
CH Jolimont
Haine-Saint-Paul
Jessa Ziekenhuis
Hasselt
Az Groeninghe Kortrijk
Kortrijk
UZ Leuven
Leuven
CHC Liège
Liège
CHR Citadelle
Liège
CHU de Liège
Liège
CHU UCL Namur, site Godinne
Namur
Clinique St-Pierre Ottignies
Ottignies
AZ Delta
Roeselare
AZ St Nikolaas
Saint-Nicolas
St Trudo Ziekenhuis
Sint-Truiden
AZ Turnhout
Turnhout

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions: Stage IV Non-small Cell Lung Cancer
Being tested: None - Common practice
Keywords: Treatment choice
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

None - Common practiceOther
None - Common practice

Study groups in NCT03959137
Study group	Role	What they receive
Primary study group		Stage IV untreated NSCLC Receives: Other: None - Common practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: during visits 1 and 2, up to approximately 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 201931 Oct 2019

First posted22 May 2019
Study start3 Jun 2019
Primary completion31 Oct 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03959137
Sponsor's protocol ID: VEAP7678
Acronym: BEPACT- Lung
Status last verified: Mar 2021
First submitted: 20 May 2019
Last updated: 9 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer

All Stage IV Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03959137
Acronym / sponsor ID: BEPACT- Lung / VEAP7678
Conditions: Stage IV Non-small Cell Lung Cancer
Keywords: Treatment choice
Study type: Observational
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: MSD Belgium BVBAIndustry (pharma, biotech, devices)
Study start: 3 Jun 2019 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 22 May 2019 (actual)
Results: Posted 9 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Primary study group	–	Other: None - Common practiceStage IV untreated NSCLC

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
None - Common practiceNone - Common practice	Other	Primary study group

Primary outcome

The Study Outcome is Defined as the Systemic Treatment Choice.
Time frame: 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.

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Study Group - Single Arm	215	209

Primary outcome: The Study Outcome is Defined as the Systemic Treatment Choice.

Time frame: during visits 1 and 2, up to approximately 3 weeks. Count of participants. Unit: Participants

Measure	Primary Study Group n = 209
Chemotherpay	26
Immunotherapy	68
Immunotherapy combined therapies	0
Immunotherapy + chemotherapy	99
Immunotherapy + bevacizumab + chemotherapy	0
Best supportive care	16

Adverse events

Time frame: Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Study Group - Single Arm	13 of 215 (6%)	1 of 215 (0.5%)	4 of 215

Limitations and caveats (from the sponsor): The experiment is not interventional and cross sectional.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stage IV Non-small Cell Lung Cancer

RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stage IV Non-small Cell Lung Cancer, run by MSD Belgium BVBA at 21 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Study Outcome is Defined as the Systemic Treatment Choice. (time frame: during visits 1 and 2, up to approximately 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.