Carcinoma, Non-Small-Cell LungPhase 1NCT03780725
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
A Phase 1 study testing BI 754111, [89Zr]Zr-BI 754111 and BI 754091 in people with Carcinoma, Non-Small-Cell Lung and Head and Neck Neoplasms, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
The main objective of this study is to determine the biodistribution and intra-tumor accumulation of [89Zr]Zr-BI 754111 at baseline and its change upon treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
- What is being tested?
- BI 754111, [89Zr]Zr-BI 754111 and BI 754091
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2019to 8 Dec 2020
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written Informed Consent Form (ICF) prior to any trial specific procedures, sampling, or analyses
- Patients of legal age (according to local legislation) at the time of signature of the ICF
- Patients with histologically confirmed diagnosis of recurrent NSCLC who received anti- PD-1 or anti PD-L1 as Part of last treatment with at least 3 months of stable disease (i.e.patients with confirmed response (PR or CR) regardless of duration of response or stable disease (SD) for a minimum of 3 months) and have become refractory to anti-PD- 1/ anti-PD-L1 based treatment OR
- --Patients with histologically confirmed diagnosis of recurrent metastatic HNSCC who progressed after platinum based therapy or not indicated for receiving standard (radio) chemotherapy (previous treatment with anti- PD-1/ PD-L1 is allowed)
- Eastern Cooperative Oncology Group (ECOG, R01-0787) score: 0 to 1
- Patient must have at least one PET imageable and evaluable tumor lesion of 20mm
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- Patients must have at least one tumor lesion amenable to biopsy. This lesion should be PET imageable and evaluable as defined above and the biopsy should be obtained before first BI 754091 administration, unless medically contra-indicated. In the latter case, 25 4μm sections from an archival biopsy taken at relapse after the previous treatment are acceptable
- Must have evaluable lesion(s) according to Revised Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and iRECIST
- Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement
- Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial Participation and for at least 6 months after the last administration of trial medication. A list of contraception methods meeting these criteria is provided in the patient information.
Who cannot join
- Not having fully recovered from major surgery before they enter into the trial according to investigator judgment or planned for major surgery within 12 months after screening, e.g. hip replacement
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled
- Previous treatment in this trial
- Any investigational or anti-tumor treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy
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- Prior treatment with anti-LAG-3 agents
- Presence of other active invasive cancers other than the one treated in this trial, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment
- Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may Participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
- Inadequate organ function or bone marrow reserve as demonstrated by the laboratory values
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) >470 msec
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
- Ejection fraction <55% or the lower limit of normal of the institutional standard.
- History of pneumonitis within the last 5 years
- History of severe hypersensitivity reactions to other mAbs
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
- Active infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at start of treatment in this trial
- Known history of human immunodeficiency virus infection or an active hepatitis B or C virus infection
- Interstitial lung disease
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes him/her an unreliable trial patient or unlikely to complete the trial or unable to comply with the protocol procedures
- Women who are pregnant, nursing, or who plan to become pregnant in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase I 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
The main objective of this study is to determine the biodistribution and intra-tumor accumulation of [89Zr]Zr-BI 754111 at baseline and its change upon treatment
- Being tested
- BI 754111, [89Zr]Zr-BI 754111, BI 754091
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 754111Drug
Solution for infusion
[89Zr]Zr-BI 754111Drug
Solution for infusion
BI 754091Drug
Also called Ezabenlimab
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Ezabenlimab 240mg + BI 754111 600mg | Experimental | Not described Receives: Drug: BI 754111; Drug: [89Zr]Zr-BI 754111; Drug: BI 754091 |
| Part 2: Ezabenlimab 240mg + BI 754111 40mg | Experimental | Not described Receives: Drug: BI 754111; Drug: [89Zr]Zr-BI 754111; Drug: BI 754091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1
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.
Measured: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2
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.
Measured: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start22 Jan 2019
- Primary completion19 Feb 2020
- Study completion8 Dec 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The trial is divided in 2 Parts and will be conducted in a staggered approach, i.e. Part 2 follows Part 1. Part 2 will be initiated following a positive decision of the Study Monitoring Committee (SMC) after reviewing of all available data from Part 1 in order to assess whether a blockade of \[89Zr\]Zr-BI 754111 will be demonstrated.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780725
- Sponsor's protocol ID
- 1381-0003
- Other IDs
- 2017-005046-30, 2017
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2018
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Publications
Miedema IHC, Huisman MC, Zwezerijnen GJC, Grempler R, Pitarch AP, Thiele A, Hesse R, Elgadi M, Peltzer A, Vugts DJ, van Dongen GAMS, de Gruijl TD, Menke-van der Houven van Oordt CW, Bahce I. 89Zr-immuno-PET using the anti-LAG-3 tracer [89Zr]Zr-BI 754111: demonstrating target specific binding in NSCLC and HNSCC. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):2068-2080. doi: 10.1007/s00259-023-06164-w. Epub 2023 Mar 2.
PubMed 36859619
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I 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
- ClinicalTrials.gov ID
- NCT03780725
- Acronym / sponsor ID
- 1381-0003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine the biodistribution and intra-tumor accumulation of [89Zr]Zr-BI 754111 at baseline and its change upon treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is divided in 2 Parts and will be conducted in a staggered approach, i.e. Part 2 follows Part 1. Part 2 will be initiated following a positive decision of the Study Monitoring Committee (SMC) after reviewing of all available data from Part 1 in order to assess whether a blockade of [89Zr]Zr-BI 754111 will be demonstrated.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Ezabenlimab 240mg + BI 754111 600mg | Experimental | Drug: BI 754111, Drug: [89Zr]Zr-BI 754111, Drug: BI 754091 |
| Part 2: Ezabenlimab 240mg + BI 754111 40mg | Experimental | Drug: BI 754111, Drug: [89Zr]Zr-BI 754111, Drug: BI 754091 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated, written Informed Consent Form (ICF) prior to any trial specific procedures, sampling, or analyses
- Patients of legal age (according to local legislation) at the time of signature of the ICF
- Patients with histologically confirmed diagnosis of recurrent NSCLC who received anti- PD-1 or anti PD-L1 as Part of last treatment with at least 3 months of stable disease (i.e.patients with confirmed response (PR or CR) regardless of duration of response or stable disease (SD) for a minimum of 3 months) and have become refractory to anti-PD- 1/ anti-PD-L1 based treatment OR
- --Patients with histologically confirmed diagnosis of recurrent metastatic HNSCC who progressed after platinum based therapy or not indicated for receiving standard (radio) chemotherapy (previous treatment with anti- PD-1/ PD-L1 is allowed)
- Eastern Cooperative Oncology Group (ECOG, R01-0787) score: 0 to 1
Key exclusion criteria (24 listed)
- Not having fully recovered from major surgery before they enter into the trial according to investigator judgment or planned for major surgery within 12 months after screening, e.g. hip replacement
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled
- Previous treatment in this trial
- Any investigational or anti-tumor treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
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 |
|---|---|---|
| BI 754111Solution for infusion | Drug | Part 1: Ezabenlimab 240mg + BI 754111 600mg, Part 2: Ezabenlimab 240mg + BI 754111 40mg |
| [89Zr]Zr-BI 754111Solution for infusion | Drug | Part 1: Ezabenlimab 240mg + BI 754111 600mg, Part 2: Ezabenlimab 240mg + BI 754111 40mg |
| BI 754091Also: EzabenlimabSolution for infusion | Drug | Part 1: Ezabenlimab 240mg + BI 754111 600mg, Part 2: Ezabenlimab 240mg + BI 754111 40mg |
Primary outcome
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1
Time frame: 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 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.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36859619Miedema IHC, Huisman MC, Zwezerijnen GJC, Grempler R, Pitarch AP, Thiele A, Hesse R, Elgadi M, Peltzer A, Vugts DJ, van Dongen GAMS, de Gruijl TD, Menke-van der Houven van Oordt CW, Bahce I. 89Zr-immuno-PET using the anti-LAG-3 tracer [89Zr]Zr-BI 754111: demonstrating target specific binding in NSCLC and HNSCC. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):2068-2080. doi: 10.1007/s00259-023-06164-w. Epub 2023 Mar 2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 754111, [89Zr]Zr-BI 754111 and BI 754091 in people with Carcinoma, Non-Small-Cell Lung and Head and Neck Neoplasms, run by Boehringer Ingelheim at 1 site in Netherlands.
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 10 inclusion and 24 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: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2026). 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?
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1 (time frame: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.). The study lists 2 primary outcomes in all. 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 NCT03780725, which also lists 1 linked publication.
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 13 Jan 2026.