BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium
- 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
- 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.
- 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
Group Intervention Description Primary study group None - Common practice Stage IV untreated NSCLC
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Imelda Ziekenhuis
π§πͺBonheiden, Belgium
St Trudo Ziekenhuis
π§πͺSint-Truiden, Belgium
CH de Charleroi
π§πͺCharleroi, Belgium
CH Jolimont
π§πͺHaine-Saint-Paul, Belgium
Jessa Ziekenhuis
π§πͺHasselt, Belgium
UZ Gent
π§πͺGent, Belgium
Az Groeninghe Kortrijk
π§πͺKortrijk, Belgium
CHU UCL Namur, site Godinne
π§πͺNamur, Belgium
Clinique St-Pierre Ottignies
π§πͺOttignies, Belgium
AZ Turnhout
π§πͺTurnhout, Belgium
CHU de Liège
π§πͺLiΓ¨ge, Belgium
AZ Delta
π§πͺRoeselare, Belgium
Cliniques Universitaires Saint-Luc UCL Bruxelles
π§πͺBrussels, Belgium
UZ Leuven
π§πͺLeuven, Belgium
CHR Citadelle
π§πͺLiΓ¨ge, Belgium
AZ St Nikolaas
π§πͺSaint-Nicolas, Belgium
UZA
π§πͺAntwerpen, Belgium
ZNA Middelheim
π§πͺAntwerpen, Belgium
UZ Brussel
π§πͺBrussel, Belgium
CHIREC
π§πͺBruxelles, Belgium
CHC Liège
π§πͺLiΓ¨ge, Belgium