Trial Outcomes & Findings for BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium (NCT NCT03959137)

Last Updated: 2021-09-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

215 participants

Primary outcome timeframe

during visits 1 and 2, up to approximately 3 weeks

Results posted on

2021-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Primary Study Group - Single Arm 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)
Overall Study STARTED	215
Overall Study COMPLETED	209
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Study Group - Single Arm 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)
Overall Study Protocol Violation	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Study Group n=209 Participants 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)
Age, Continuous	68.2 Years STANDARD_DEVIATION 9.2 • n=209 Participants
Sex: Female, Male Female	73 Participants n=209 Participants
Sex: Female, Male Male	136 Participants n=209 Participants
Histology Squamous	57 Participants n=209 Participants
Histology Non-squamous	137 Participants n=209 Participants
Histology Not otherwise specified	15 Participants n=209 Participants
ECOG ECOG 0	40 Participants n=209 Participants
ECOG ECOG 1	121 Participants n=209 Participants
ECOG ECOG 2	34 Participants n=209 Participants
ECOG ECOG 3-4	11 Participants n=209 Participants
ECOG Unknown	3 Participants n=209 Participants
Smoking Status Current	99 Participants n=209 Participants
Smoking Status Former (>1 year)	101 Participants n=209 Participants
Smoking Status Never	8 Participants n=209 Participants
Smoking Status Unknown	1 Participants n=209 Participants
IHC PD-L1 Tumor Proportion Score (TPS) <1%	69 Participants n=209 Participants
IHC PD-L1 Tumor Proportion Score (TPS) 1-49%	45 Participants n=209 Participants
IHC PD-L1 Tumor Proportion Score (TPS) >=50%	88 Participants n=209 Participants
IHC PD-L1 Unknown	7 Participants n=209 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Primary Study Group n=209 Participants Confirmed diagnosis of stage IV NSCLC on first-line (1L) systemic treatment
The Study Outcome is Defined as the Systemic Treatment Choice. Chemotherpay	26 Participants
The Study Outcome is Defined as the Systemic Treatment Choice. Immunotherapy	68 Participants
The Study Outcome is Defined as the Systemic Treatment Choice. Immunotherapy combined therapies	0 Participants
The Study Outcome is Defined as the Systemic Treatment Choice. Immunotherapy + chemotherapy	99 Participants
The Study Outcome is Defined as the Systemic Treatment Choice. Immunotherapy + bevacizumab + chemotherapy	0 Participants
The Study Outcome is Defined as the Systemic Treatment Choice. Best supportive care	16 Participants

Adverse Events

Primary Study Group - Single Arm

Serious events: 13 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Primary Study Group - Single Arm n=215 participants at risk 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.
Gastrointestinal disorders Hospitalization	1.4% 3/215 • Number of events 3 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Respiratory, thoracic and mediastinal disorders Hospitalization	1.9% 4/215 • Number of events 4 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Cardiac disorders pericardial fluid accumulation	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
General disorders Worsened general condition	0.93% 2/215 • Number of events 2 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain metastasis (progression)	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Skin and subcutaneous tissue disorders Inflammatory folliculitis	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
General disorders Hospitalisation	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Blood and lymphatic system disorders Eosinophelia	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Nervous system disorders Hospitalization	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.

Other adverse events

Other adverse events
Measure	Primary Study Group - Single Arm n=215 participants at risk 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.
Skin and subcutaneous tissue disorders Itching	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Skin and subcutaneous tissue disorders Cutaneous eruption	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.
Blood and lymphatic system disorders Eosinophelia	0.47% 1/215 • Number of events 1 • Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum. 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.

Additional Information

Stephanie Coulon

MSD Belgium

Phone: 0032 485 461 467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60