BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary study group Stage IV untreated NSCLC |
Other: None - Common practice
None - Common practice
|
Outcome Measures
Primary Outcome Measures
- 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 : Chemotherapy (chemo) Immunotherapy (IO) immuno combined therapies (IO+IO) IO+chemo IO+bevacizumab+chemo (IO+bev+chemo) best supportive care (BSC). There is no exposure in this study.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZA | Antwerpen | Belgium | ||
| 2 | ZNA Middelheim | Antwerpen | Belgium | ||
| 3 | Imelda Ziekenhuis | Bonheiden | Belgium | ||
| 4 | Cliniques Universitaires Saint-Luc UCL Bruxelles | Brussels | Belgium | ||
| 5 | UZ Brussel | Brussel | Belgium | ||
| 6 | CHIREC | Bruxelles | Belgium | ||
| 7 | CH de Charleroi | Charleroi | Belgium | ||
| 8 | UZ Gent | Gent | Belgium | ||
| 9 | CH Jolimont | Haine-Saint-Paul | Belgium | ||
| 10 | Jessa Ziekenhuis | Hasselt | Belgium | ||
| 11 | Az Groeninghe Kortrijk | Kortrijk | Belgium | ||
| 12 | UZ Leuven | Leuven | Belgium | ||
| 13 | CHC Liège | Liège | Belgium | ||
| 14 | CHR Citadelle | Liège | Belgium | ||
| 15 | CHU de Liège | Liège | Belgium | ||
| 16 | CHU UCL Namur, site Godinne | Namur | Belgium | ||
| 17 | Clinique St-Pierre Ottignies | Ottignies | Belgium | ||
| 18 | AZ Delta | Roeselare | Belgium | ||
| 19 | AZ St Nikolaas | Saint-Nicolas | Belgium | ||
| 20 | St Trudo Ziekenhuis | Sint-Truiden | Belgium | ||
| 21 | AZ Turnhout | Turnhout | Belgium |
Sponsors and Collaborators
- MSD Belgium BVBA
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- VEAP7678
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Primary Study Group - Single Arm |
|---|---|
| Arm/Group Description | Stage IV untreated non-small cell lung cancer (NSCLC) Patient disposition: Enrolled patients n=215 Eligible patients n=209 Total of 215 patients were enrolled in the study at 21 different sites between 03 June 2019 and 31 October 2019. Of the enrolled patients, 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria) |
| Period Title: Overall Study | |
| STARTED | 215 |
| COMPLETED | 209 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Primary Study Group |
|---|---|
| Arm/Group Description | A total of 215 patients were enrolled in the study and 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria). All analyses were performed on the Eligible Population. Demography data Age (years) Gender (male or female) Weight loss (%) Smoking status (current, former (defined as smoking ≥ 1 year), never, or unknown) ECOG status (0, 1, 2, 3-4, or unknown) Patient's preference for treatment choice (yes, no, or unknown) |
| Overall Participants | 209 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
68.2
(9.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
73
34.9%
|
| Male |
136
65.1%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Histology (Count of Participants) | |
| Squamous |
57
27.3%
|
| Non-squamous |
137
65.6%
|
| Not otherwise specified |
15
7.2%
|
| ECOG (Count of Participants) | |
| ECOG 0 |
40
19.1%
|
| ECOG 1 |
121
57.9%
|
| ECOG 2 |
34
16.3%
|
| ECOG 3-4 |
11
5.3%
|
| Unknown |
3
1.4%
|
| Smoking Status (Count of Participants) | |
| Current |
99
47.4%
|
| Former (>1 year) |
101
48.3%
|
| Never |
8
3.8%
|
| Unknown |
1
0.5%
|
| IHC PD-L1 (Count of Participants) | |
| Tumor Proportion Score (TPS) <1% |
69
33%
|
| Tumor Proportion Score (TPS) 1-49% |
45
21.5%
|
| Tumor Proportion Score (TPS) >=50% |
88
42.1%
|
| Unknown |
7
3.3%
|
Outcome Measures
| Title | The Study Outcome is Defined as the Systemic Treatment Choice. |
|---|---|
| Description | Systemic treatment choices are defined as : Chemotherapy (chemo) Immunotherapy (IO) immuno combined therapies (IO+IO) IO+chemo IO+bevacizumab+chemo (IO+bev+chemo) best supportive care (BSC). There is no exposure in this study. |
| Time Frame | during visits 1 and 2, up to approximately 3 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Primary Study Group |
|---|---|
| Arm/Group Description | Confirmed diagnosis of stage IV NSCLC on first-line (1L) systemic treatment |
| Measure Participants | 209 |
| Chemotherpay |
26
12.4%
|
| Immunotherapy |
68
32.5%
|
| Immunotherapy combined therapies |
0
0%
|
| Immunotherapy + chemotherapy |
99
47.4%
|
| Immunotherapy + bevacizumab + chemotherapy |
0
0%
|
| Best supportive care |
16
7.7%
|
Adverse Events
| Time Frame | Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse Event Reporting INVESTIGATOR RESPONSIBILITY: If the investigator becomes aware of any serious adverse event (SAE), including death due to any cause, or non-serious adverse reaction (NSAR) following the use of any Merck product, the event must be reported according to Table 1. The investigator must evaluate each SAE for causality and record causality on the AE form for each event reported. | |
| Arm/Group Title | Primary Study Group - Single Arm | |
| Arm/Group Description | This is a primary data collection non-interventional study being conducted within routine medical practice. All direction for medication usage is at the discretion of a physician in accordance with usual medical practice. No administration of any therapeutic or prophylactic agent is required in this protocol, and there are no procedures required as part of this protocol. | |
All Cause Mortality |
||
| Primary Study Group - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/215 (1.9%) | |
Serious Adverse Events |
||
| Primary Study Group - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/215 (6%) | |
| Blood and lymphatic system disorders | ||
| Eosinophelia | 1/215 (0.5%) | 1 |
| Cardiac disorders | ||
| pericardial fluid accumulation | 1/215 (0.5%) | 1 |
| Gastrointestinal disorders | ||
| Hospitalization | 3/215 (1.4%) | 3 |
| General disorders | ||
| Worsened general condition | 2/215 (0.9%) | 2 |
| Hospitalisation | 1/215 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Brain metastasis (progression) | 1/215 (0.5%) | 1 |
| Nervous system disorders | ||
| Hospitalization | 1/215 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hospitalization | 4/215 (1.9%) | 4 |
| Skin and subcutaneous tissue disorders | ||
| Inflammatory folliculitis | 1/215 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Primary Study Group - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/215 (0.5%) | |
| Blood and lymphatic system disorders | ||
| Eosinophelia | 1/215 (0.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Itching | 1/215 (0.5%) | 1 |
| Cutaneous eruption | 1/215 (0.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Stephanie Coulon |
|---|---|
| Organization | MSD Belgium |
| Phone | 0032 485 461 467 |
| stephanie.coulon@merck.com |
- VEAP7678