BI 836880 combined with BI 754091 in patients with cancer
Research type
Research Study
Full title
An open label phase Ib dose finding study of BI 836880 in combination with BI 754091 to characterize safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and in other solid tumors.
IRAS ID
271688
Contact name
Tim Meyer
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2017-001378-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 3 days
Research summary
Summary of Research
This is an open label phase Ib dose finding study of BI 836880 in combination with BI 754091 to characterise safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and in other solid tumors. The purpose of the Part 1 of this study is to determine the appropriate dose to be used in the Part 2 of this study. The response of the tumour to the combination of BI 836880 and BI 754091 will be assessed in Part 2 of this study in patients with locally advanced or metastatic non-squamous NSCLC and other solid tumours. The UK will be participating in Phase 2 only. Approximately 12 countries and approximately 218 patients in total will participate worldwide. Part 2 will be opened for recruitment once the appropriate dose is determined in Part 1.
A total of 200 patients will be entered into Part 2. Participants will be assigned to one group (cohort) according to their disease and previous treatment. Participants will be treated by BI 836880 and BI 754091 by infusion every 3 weeks and will be treated until disease progression or until intolerable toxicity has been observed, provided participants show a stable disease or even a disease response to the treatment.
Summary of Results
Study title:
A study to test different doses of BI 836880 combined with ezabenlimab in patients with advanced nonsmall
cell lung cancer followed by other types of advanced solid tumours
This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 836880 and
ezabenlimab and the treatment of advanced cancer.
What was this study about?
The purpose of this study was to find the highest dose of a medicine called BI 836880 that people with
advanced non-small cell lung cancer could tolerate when taken together with another medicine called
ezabenlimab. We also wanted to know whether BI 836880 in combination with ezabenlimab helps people
with different types of advanced solid tumours.
BI 836880 and ezabenlimab are medicines being developed to treat people with different types of cancer.
When we develop new medicines, we need to understand how different doses affect the body.
Who took part in this study?
Adults with advanced cancer could take part in this study. A total of 252 people participated. The study
consisted of 2 parts.
Part 1:
14 people with advanced non-small cell lung cancer participated. All participants in this part had previously
received treatment before they entered the study and their cancer had returned or spread after that initial
treatment. In this part, there were 9 men and 5 women. The youngest participant was 38 years old, and the
oldest participant was 75 years old.
Part 2:
238 people with different types of advanced solid tumours participated. In this part, there were 163 men
and 75 women. The youngest participant was 26 years old, and the oldest participant was 88 years old. The
average age of participants in Part 2 was 62 years.
How was this study done?
The participants were divided into 4 groups randomly, like drawing names from a hat.
The groups were BI 1291583 low dose group, BI 1291583 medium dose group, BI 1291583 high dose group
In Part 1, participants received 360 mg, 500 mg, or 720 mg of BI 836880 in combination with ezabenlimab
as infusions into a vein once every 3 weeks. The first participants received lower doses of BI 836880, and
participants who started the study later received higher doses. The participants and doctors knew which
dose each participant was receiving.
For this part, we wanted to find the highest dose of BI 836880 participants could tolerate when taken
together with ezabenlimab. To find out, we looked at the number of participants with certain severe health
problems that happened within 3 weeks after the first treatment.
Part 2:
In Part 2, all participants received 720 mg of BI 836880 in combination with 240 mg of ezabenlimab as
infusions into a vein once every 3 weeks.
For this part, we wanted to know whether BI 836880 treatment in combination with ezabenlimab helped
shrink the participants’ tumours. To find out, we measured the percentage of participants whose tumours
shrunk or disappeared after treatment. This was based on images of the tumours taken during the study.
Participants in both parts of this study could continue to receive the medicines for up to 3 years as long as it
was safe and their cancer was not becoming worse.
Participants visited the doctors regularly. During these visits, the doctors collected information about the
participants’ health.
What were the results of this study?
Part 1:
All 3 doses of BI 836880 in combination with 240 mg ezabenlimab were tolerated by participants in this
part of the study. Within 3 weeks of the first treatment, 1 participant out of 14 had a severe health
problem, which was a blockage of an artery in the lungs (pulmonary embolism).
Part 2:
45 participants out of 238 (19%) showed an objective response with BI 836880 and ezabenlimab treatment.
This means that their tumours shrunk or disappeared after BI 836880 and ezabenlimab treatment. 43
participants (18%) had tumours shrink, and 2 participants (1%) had tumours disappear.
Did participants have any unwanted effects in this study?
Yes, participants in both parts of the study had unwanted effects. Unwanted effects are health problems
that the doctors think were caused by the study medicines.
In Part 1 of the study, 12 out of 14 participants (86%) had unwanted effects. In Part 2 of the study, 160 out
of 238 participants (67%) had unwanted effects.
The listing below shows the most common unwanted effects for each part of the study. The listing also
shows how many participants in each part had each of these unwanted effects. There were 14 participants
in Part 1 (BI 836880 360/500/720 mg + ezabenlimab) and 238 participants in Part 2 (BI 836880 720 mg +
ezabenlimab).
High blood pressure (hypertension): 6 participants (43%) in Part 1 and 38 participants in Part 2 (16%).
Weakness (asthenia): 4 participants (29%) in Part 1 and 33 participants in Part 2 (14%).
Diarrhoea: 3 participants (21%) in Part 1 and 28 participants in Part 2 (12%).
Too much protein in the urine (proteinuria): 2 participants (14%) in Part 1 and 22 participants in Part 2 (9%).
Underactive thyroid gland (hypothyroidism): 2 participants (14%) in Part 1 and 18 participants in Part 2
(8%).
Reaction caused by the infusion (infusion related reaction): 0 participants (0%) in Part 1 and 17 participants
in Part 2 (7%).
Some unwanted effects in this study were serious because they required a stay in the hospital or a longer
stay in hospital, were life-threatening, were fatal, or the doctor thought they were serious for any other
reason.
In Part 1 of this study, 5 out of 14 participants (36%) had serious unwanted effects. The serious unwanted
effects were underactive thyroid gland (hypothyroidism), blockage of an artery in the heart (coronary
artery occlusion), high blood pressure (hypertension), lung fibrosis (interstitial lung disease), blockage of an
artery in the lungs (pulmonary embolism), and bleeding in the airway (tracheal haemorrhage). 1 participant
died from unwanted effects.
In Part 2 of this study, 38 out of 238 participants (16%) had serious unwanted effects. The most common
serious unwanted effects were reaction caused by the infusion (infusion related reaction), diarrhoea,
inflammation of the bowel (colitis), and a blood clot in a vein (deep vein thrombosis). 4 participants died
from unwanted effects.
Where did the study take place?
The following listing shows the regions and countries with the number of participants.
Europe (183 participants): France (74), Spain (51), Germany (19), Poland (16), Russian Federation (12),
Ukraine (6), UK (5)
Asia (36 participants): Korea (31), Taiwan (3), Hong Kong (2)
Australia (21): Australia (21)
North America (12): United States (12)
The total number of participants in the European Union was 160.
Is there more information about this study?
You can find further information about this study at these websites:
1. Go to www.mystudywindow.com/completed and search for the study number 1336-0011.
2. Go to www.clinicaltrialsregister.eu/ctr-search and search for the EudraCT number 2017-001378-41.
3. Go to www.clinicaltrials.gov and search for the NCT number NCT03468426.
Boehringer Ingelheim sponsored this study. For contact details, please visit www.boehringeringelheim.
com/contact-us.
The full title of the study is: An open-label Phase Ib dose finding study of BI 836880 in
combination with ezabenlimab to characterize safety, tolerability, pharmacokinetics, pharmacodynamics,
and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and
in other solid tumours
The study is still ongoing at the time this lay summary was written.
Are there additional studies?
If we do more clinical studies with BI 836880 and ezabenlimab you will find them on the websites listed
above. To search for these studies, use the words BI 836880 and ezabenlimab.
Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study
results.
This summary shows only the results from one study and may not represent all of the knowledge about the
medicine studied. Other studies may have different results. Usually, more than one study is carried out to
find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may
be approved or not approved in your country. This lay summary is not intended to promote any product or
indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating
physician about your therapy.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1918
Date of REC Opinion
19 Dec 2019
REC opinion
Favourable Opinion