Trial Outcomes & Findings for This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091 (NCT NCT03780725)

Last Updated: 2026-01-13

Results Overview

The standardized uptake values (SUVs) are calculated as the ratios of the image derived radioactivity concentration upon the whole body concentration of the injected radioactivity, i.e. image derived radioactivity concentration / injected radioactivity concentration upon the whole body - a unitless value since the unit has been cancelled out. The Standard uptake value (SUV) in a 1 milliliter (mL) sphere around highest SUV pixel (SUVpeak) of \[89Zr\]Zr-BI 754111 for tumor uptake for part 1 participants is reported. The SUVpeak (also unitless since it is a SUV value) is summarized for each imaging time point (96hour, 144hour) as the mean tumor uptake over all selected lesions for each treatment cycle, respectively.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.

Results posted on

2026-01-13

Participant Flow

This was an open label Positron Emission Tomography (PET) imaging study to investigate the bio-distribution and tumor uptake of \[89Zr\]Zr-BI 754111 in patients with advanced non-small cell lung cancer and head and neck squamous cell carcinoma treated with BI 754111 in combination with BI 754091.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.	Part 2: Ezabenlimab 240mg + BI 754111 40mg Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 40 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.
Overall Study STARTED	3	5
Overall Study Treated with at least one dose of Ezabenlimab and BI 754111	3	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.	Part 2: Ezabenlimab 240mg + BI 754111 40mg Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 40 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.
Overall Study Progression of disease	3	4
Overall Study Adverse Event	0	1

Baseline Characteristics

This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg n=3 Participants Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.	Part 2: Ezabenlimab 240mg + BI 754111 40mg n=5 Participants Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 40 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.	Total n=8 Participants Total of all reporting groups
Age, Continuous	65.3 Years STANDARD_DEVIATION 9.0 • n=210 Participants	64.6 Years STANDARD_DEVIATION 8.6 • n=19 Participants	64.9 Years STANDARD_DEVIATION 8.1 • n=123 Participants
Sex: Female, Male Female	0 Participants n=210 Participants	1 Participants n=19 Participants	1 Participants n=123 Participants
Sex: Female, Male Male	3 Participants n=210 Participants	4 Participants n=19 Participants	7 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=210 Participants	5 Participants n=19 Participants	8 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) White	3 Participants n=210 Participants	5 Participants n=19 Participants	8 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants

PRIMARY outcome

Timeframe: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.

Population: Treated Set (TS): This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab). Only participants from part 1 are included in this analysis.

Outcome measures

Outcome measures
Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg n=3 Participants Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1 Cycle 2 (on-treatment phase) - 96 hours	6.2 SUV ratio Standard Deviation 2.7
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1 Cycle 1 (baseline phase) - 96 hours	5.5 SUV ratio Standard Deviation 1.0
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1 Cycle 1 (baseline phase) - 144 hours	5.2 SUV ratio Standard Deviation 1.0
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1 Cycle 2 (on-treatment phase) - 144 hours	7.0 SUV ratio Standard Deviation 3.6

PRIMARY outcome

Timeframe: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.

The standardized uptake values (SUVs) are calculated as the ratios of the image derived radioactivity concentration upon the whole body concentration of the injected radioactivity, i.e. image derived radioactivity concentration / injected radioactivity concentration upon the whole body - a unitless value since the unit has been cancelled out. The Standard uptake value (SUV) in a 1 milliliter (mL) sphere around highest SUV pixel (SUVpeak) of \[89Zr\]Zr-BI 754111 for tumor uptake for part 2 participants is reported. The SUVpeak (also unitless since it is a SUV value) is summarized for each imaging time point (96hour, 144hour) as the mean tumor uptake over all selected lesions for each treatment cycle, respectively.

Outcome measures

Outcome measures
Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg n=3 Participants Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2 Cycle 1 (baseline phase) - 96 hours	5.8 SUV ratio Standard Deviation 4.4
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2 Cycle 2 (on-treatment phase) - 96 hours	4.6 SUV ratio Standard Deviation 1.9
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2 Cycle 1 (baseline phase) - 144 hours	4.9 SUV ratio Standard Deviation 3.6
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2 Cycle 2 (on-treatment phase) - 144 hours	4.3 SUV ratio Standard Deviation 2.0

Adverse Events

Part 1: Ezabenlimab 240mg + BI 754111 600mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Ezabenlimab 240mg + BI 754111 40mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part 1: Ezabenlimab 240mg + BI 754111 600mg n=3 participants at risk Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.	Part 2: Ezabenlimab 240mg + BI 754111 40mg n=5 participants at risk Baseline assessment phase (Cycle 1): 240 milligrams (mg) solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 1, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 1. On-treatment phase (Cycle 2): 40 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of Cycle 2, followed by 4 milligrams solution for infusion of \[89Zr\]Zr-BI 754111 (4mg BI 754111 - 37 MBq) administered via intravenous infusion no later than Day 8 of Cycle 2. On-treatment phase (Cycle 3 and the following cycles): 600 mg solution for infusion of BI 754111 together with 240 mg solution for infusion of BI 754091 (ezabenlimab) were administered by intravenous infusion on Day 1 of each cycle. Each cycle last for 3 weeks. From Cycle 2 onwards, intravenous infusions of BI 754111 plus BI 754091 (ezabenlimab) once every 3 weeks until progression of disease, unacceptable toxicity, or maximum treatment duration of 1 year.
General disorders Pyrexia	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	40.0% 2/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
General disorders Malaise	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
General disorders Asthenia	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Infections and infestations Infectious pleural effusion	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Infections and infestations Medical device site infection	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Infections and infestations Respiratory tract infection	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Blood and lymphatic system disorders Microcytic anaemia	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Gastrointestinal disorders Gastric haemorrhage	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Nervous system disorders Tremor	0.00% 0/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	20.0% 1/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Product issues Device malfunction	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	33.3% 1/3 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).	0.00% 0/5 • From first dose of study medication until end of treatment + 30 days, up to 255 days. Treated Set (TS) : This patient set includes all patients who were documented to have received at least one dose of \[89Zr\]Zr-BI 754111, BI 754111, or BI 754091 (ezabenlimab).