A Phase 1 interventional study of BI 836880 and Ezabenlimab in Non-squamous, Non-Small-Cell Lung Cancer and Neoplasms, sponsored by Boehringer Ingelheim. Completed at 43 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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Among 68 studies in Carcinoma, Non-Small-Cell Lung by Boehringer Ingelheim — 3 open to participants now, 5 under way, 1 of them phase 3. Carcinoma, Non-Small-Cell Lung · Boehringer Ingelheim.
Among the 68 studies in Carcinoma, Non-Small-Cell Lung by Boehringer Ingelheim, this one is the 13th largest by enrollment of the 49 interventional ones that give a count, is the only one that started in 2018, is one of 21 in phase 1, and was the 57th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →3 of the 68 studies in Carcinoma, Non-Small-Cell Lung by Boehringer Ingelheim are open now, in 12 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Argentina, Australia and 25 more countries
Ages 18+
Boehringer Ingelheim · Sites in United States, Australia, Austria and 15 more countries
Ages 18+
Boehringer Ingelheim · Sites in Japan
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 252 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 44 across the 49 interventional studies, 216 across the 16 observational. Of the 60 that completed or were terminated, 53 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
1 of the studies in Carcinoma, Non-Small-Cell Lung by Boehringer Ingelheim that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05708599Boehringer IngelheimA Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer | 2027-02-08 |
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Among the 68 studies in Carcinoma, Non-Small-Cell Lung by Boehringer Ingelheim, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab.
BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor).
The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink.
The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1:
Part 2:
Note: Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours during the screening period. At the following visits according to the flowchart, a urine and/or serum pregnancy test is required. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.- Further inclusion criteria apply
Exclusion criteria:
Part 1:
Uncontrolled hypertension defined as: Blood pressure in rested and relaxed condition >= 140 mmHg, systolic or >= 90 mmHg diastolic (with or without medication), measured according to Appendix 10.2.
Part 2:
Uncontrolled hypertension defined as: Blood pressure in rested and relaxed condition >= 140 mmHg, systolic or >= 90 mmHg diastolic (with or without medication), measured according to Appendix 10.2.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
Drug: BI 836880 · Drug: Ezabenlimab
BI 836880 as an intravenous infusion on day 1 of each 3-week cycle.
240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle.
Also known as: BI 754091
Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment
Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.
Time frame: The first treatment cycle, up to 21 days.
Part 2 - Objective Response (OR)
Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria.
Time frame: Up to 778 days.
Part 1 - Adverse Events (AEs)
The number of patients with any adverse events (AEs).
Time frame: Up to 1263 days.
Part 1 - Drug Related AEs
The number of patients with any drug related adverse events (AEs).
Time frame: Up to 1263 days.
Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
Time frame: Up to 1263 days.
Part 2 - Adverse Events (AEs)
The number of patients with any adverse events (AEs).
Time frame: Up to 778 days.
Part 2 - Drug Related AEs
The number of patients with any drug related adverse events (AEs).
Time frame: Up to 778 days.
Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
Time frame: Up to 778 days.
Part 2 - Disease Control (DC)
Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM \& RECIST1.1 for all other cohorts).
Time frame: Up to 778 days.
Part 2 - Duration of Objective Response (DoR)
Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM \& RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR.
Time frame: Up to 84.4 weeks.
Part 2 - Progression-free Survival (PFS)
Progression-free survival (PFS) (RANO for GBM \& RECIST1.1 for all other cohorts), defined as the time from first treatment infusion until disease progression or death from any cause, whichever occurs earlier. Tumour shrinkage (in millimeters), defined as the difference between the minimum post-baseline sum of diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions in case of RECIST. In GBM, using RANO criteria, tumor shrinkage will be calculated based on the difference between the post-baseline and baseline measurements of the sum of product of the largest bi-dimensional measurements for all target lesions.
Time frame: Up to 778 days.
Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle
Part 2 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle
Part 2 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
Part 2 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the Fourth Infusion Cycle
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the Fourth Infusion Cycle
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.
Part 2 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle
Part 2 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 2 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle
Part 2 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
Part 2 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
Part 2 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Time frame: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.
This was a non-randomised, uncontrolled, open-label, dose escalating trial of BI 836880 administered in combination with ezabenlimab intravenously every 3 weeks. The trial consisted of 2 parts: Part 1 (dose escalation of BI 836880 in combination with ezabenlimab) and Part 2 (expansion phase in 8 cohorts).
| Milestone | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma (HCC) | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 8 | 42 | 40 | 31 | 31 | 32 | 30 | 31 | 1 |
| Completed | 0 | 1 | 0 | 6 | 5 | 3 | 2 | 1 | 6 | 2 | 0 |
| Not completed | 3 | 2 | 8 | 36 | 35 | 28 | 29 | 31 | 24 | 29 | 1 |
| Withdrew: Progressive disease | 3 | 0 | 4 | 20 | 23 | 15 | 24 | 27 | 13 | 13 | 0 |
| Withdrew: Other adverse event or clinical progression | 0 | 1 | 3 | 14 | 10 | 8 | 5 | 4 | 6 | 11 | 0 |
| Withdrew: Refused to continue taking trial medication | 0 | 0 | 0 | 2 | 0 | 3 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Other than listed | 0 | 1 | 0 | 0 | 2 | 2 | 0 | 0 | 4 | 4 | 1 |
| Withdrew: Dose limiting toxicity (dlt) | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Missing reason | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
The number of patients with any adverse events (AEs).
| Participants | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 1 - total |
|---|---|---|---|---|
| Part 1 - Adverse Events (AEs) | 3 | 3 | 8 | 14 |
The number of patients with any drug related adverse events (AEs).
| Participants | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 1 - total |
|---|---|---|---|---|
| Part 1 - Drug Related AEs | 3 | 2 | 7 | 12 |
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
| Participants | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 1 - total |
|---|---|---|---|---|
| Subjects with AEs leading to dose reduction of trial drug | 0 | 0 | 0 | 0 |
| Subjects with AEs leading to discontinuation of trial drug | 1 | 1 | 2 | 4 |
The number of patients with any adverse events (AEs).
| Participants | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Adverse Events (AEs) | 39 | 39 | 27 | 30 | 31 | 28 | 28 | 1 | 223 |
The number of patients with any drug related adverse events (AEs).
| Participants | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Drug Related AEs | 27 | 27 | 16 | 24 | 18 | 27 | 20 | 1 | 160 |
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
| Participants | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Subjects with AEs leading to dose reduction of trial drug | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 |
| Subjects with AEs leading to discontinuation of trial drug | 13 | 4 | 6 | 2 | 2 | 5 | 6 | 0 | 38 |
Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM \& RECIST1.1 for all other cohorts).
| Participants | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Disease Control (DC) | 34 | 25 | 12 | 25 | 18 | 24 | 25 | 1 | 164 |
Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM \& RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR.
| weeks | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Duration of Objective Response (DoR) | 23.4 (7.6 to 65.3) | 54.0 (48.4 to 58.0) | 30.0 (12.0 to 73.1) | 18.1 (10.7 to 78.3) | 43.3 (19.3 to 67.3) | 53.8 (6.3 to 84.4) | 48.9 (12.3 to 78.1) | — | 48.3 (6.3 to 84.4) |
Progression-free survival (PFS) (RANO for GBM \& RECIST1.1 for all other cohorts), defined as the time from first treatment infusion until disease progression or death from any cause, whichever occurs earlier. Tumour shrinkage (in millimeters), defined as the difference between the minimum post-baseline sum of diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions in case of RECIST. In GBM, using RANO criteria, tumor shrinkage will be calculated based on the difference between the post-baseline and baseline measurements of the sum of product of the largest bi-dimensional measurements for all target lesions.
| weeks | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Progression-free Survival (PFS) | 43.14 (15.14 to 72.29) | 20.43 (7.29 to NA) | 6.29 (5.29 to 44.71) | 16.43 (11.43 to 59.86) | 27.86 (6.64 to 47.71) | 78.14 (11.86 to NA) | 37.00 (9.14 to 67.14) | 17.86 (17.86 to 17.86) | 28.00 (8.86 to 72.00) |
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
| microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | — | NA ± na | 175 ± 21.4 |
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the fourth infusion cycle.
| microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle | — | NA ± na | 273 ± 20.9 |
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
| hours | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | — | NA ± na | 1.84 ± 134 |
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the fourth infusion cycle.
| hours | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle | — | NA ± na | 3.29 ± 91.9 |
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
| hours*microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | — | 19200 ± 28.5 | 35100 ± 20.9 |
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
| hours*microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle | — | NA ± na | 59700 ± 14.2 |
Part 2 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
| microgram/milliliter | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 251 ± 25.5 | 239 ± 30.5 | 275 ± 39.8 | 253 ± 23.4 | 240 ± 27.2 | 214 ± 20.5 | 206 ± 31.7 | NA ± na |
Part 2 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
| hours | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | 2.75 ± 72.0 | 2.61 ± 91.6 | 2.25 ± 76.9 | 2.18 ± 73.9 | 2.47 ± 76.7 | 3.08 ± 109 | 2.54 ± 113 | NA ± na |
Part 2 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
| hours*microgram/milliliter | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 44000 ± 28.2 | 41300 ± 31.1 | 42000 ± 11.1 | 44900 ± 22.4 | 38000 ± 23.8 | 39400 ± 21.4 | 36600 ± 25.2 | NA ± na |
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
| microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle | 80.7 ± 24.8 | 144 ± 78.9 | 75.8 ± 25.3 |
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the fourth infusion cycle.
| microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the Fourth Infusion Cycle | NA ± na | 131 ± 16.2 | 106 ± 20.4 |
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
| hours | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle | 1.83 ± 137 | 1.06 ± 7.84 | 2.79 ± 101 |
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the fourth infusion cycle.
| hours | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the Fourth Infusion Cycle | NA ± na | 1.55 ± 65.5 | 2.32 ± 55.6 |
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
| hours*microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 15100 ± 42.0 | 15800 ± 8.13 | 14900 ± 27.5 |
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
| hours*microgram/milliliter | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg |
|---|---|---|---|
| Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle | NA ± na | 34000 ± 17.8 | 25200 ± 32.5 |
Part 2 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
| microgram/milliliter | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle | 85.7 ± 26.3 | 80.5 ± 22.0 | 89.3 ± 27.8 | 87.7 ± 22.3 | 76.6 ± 18.2 | 74.6 ± 20.1 | 71.3 ± 28.3 | NA ± na |
Part 2 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
| hours | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle | 2.93 ± 129 | 2.90 ± 68.2 | 2.26 ± 77.8 | 2.35 ± 84.8 | 3.03 ± 65.9 | 2.38 ± 63.8 | 2.75 ± 110 | NA ± na |
Part 2 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
| hours*microgram/milliliter | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 17600 ± 29.7 | 15200 ± 35.2 | 17700 ± 16.9 | 19300 ± 22.1 | 14500 ± 25.5 | 14900 ± 23.1 | 14200 ± 31.5 | NA ± na |
Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.
| Participants | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 1 - total |
|---|---|---|---|---|
| Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment | 1 | 0 | 0 | 1 |
Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria.
| Participants | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | Part 2 - total |
|---|---|---|---|---|---|---|---|---|---|
| Part 2 - Objective Response (OR) | 7 | 3 | 6 | 7 | 2 | 12 | 8 | 0 | 45 |
Collected over From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1 - BI 836880 360 mg | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Part 1 - BI 836880 500 mg | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) |
| Part 1 - BI 836880 720 mg | 1/8 (12.5%) | 6/8 (75%) | 8/8 (100%) |
| Part 2 - Cohort A, 2nd line NSCLC | 4/42 (9.5%) | 24/42 (57.1%) | 36/42 (85.7%) |
| Part 2 - Cohort B, 3rd line NSCLC | 2/40 (5%) | 21/40 (52.5%) | 35/40 (87.5%) |
| Part 2 - Cohort C, SCLC | 5/31 (16.1%) | 14/31 (45.2%) | 23/31 (74.2%) |
| Part 2 - Cohort D, glioblastoma | 1/31 (3.2%) | 10/31 (32.3%) | 28/31 (90.3%) |
| Part 2 - Cohort E, Melanoma | 2/32 (6.3%) | 11/32 (34.4%) | 30/32 (93.8%) |
| Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | 4/30 (13.3%) | 16/30 (53.3%) | 28/30 (93.3%) |
| Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | 5/31 (16.1%) | 17/31 (54.8%) | 27/31 (87.1%) |
| Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|---|---|---|
| DizzinessNervous system disorders | 0/3 | 1/3 | 0/8 | 0/42 | 0/40 | 0/31 | 0/31 | 0/32 | 1/30 | 0/31 | 0/1 |
| Coronary artery occlusionCardiac disorders | 0/3 | 1/3 | 0/8 | 0/42 | 0/40 | 0/31 | 0/31 | 0/32 | 0/30 | 0/31 | 0/1 |
| HypothyroidismEndocrine disorders | 1/3 | 0/3 | 0/8 | 0/42 | 0/40 | 0/31 | 0/31 | 0/32 | 0/30 | 0/31 | 0/1 |
| General physical health deteriorationGeneral disorders | 0/3 | 1/3 | 0/8 | 1/42 | 0/40 | 2/31 | 0/31 | 1/32 | 0/30 | 0/31 | 0/1 |
| SepsisInfections and infestations | 1/3 | 0/3 | 0/8 | 1/42 | 1/40 | 0/31 | 0/31 | 0/32 | 2/30 | 0/31 | 0/1 |
| Skin infectionInfections and infestations | 0/3 | 1/3 | 0/8 | 0/42 | 0/40 | 0/31 | 0/31 | 0/32 | 1/30 | 0/31 | 0/1 |
| HeadacheNervous system disorders | 0/3 | 1/3 | 0/8 | 0/42 | 0/40 | 0/31 | 0/31 | 0/32 | 0/30 | 0/31 | 0/1 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/3 | 0/8 | 0/42 | 1/40 | 0/31 | 0/31 | 1/32 | 1/30 | 1/31 | 0/1 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/8 | 1/42 | 0/40 | 0/31 | 0/31 | 0/32 | 1/30 | 1/31 | 0/1 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/3 | 1/8 | 1/42 | 0/40 | 0/31 | 0/31 | 0/32 | 0/30 | 0/31 | 0/1 |
| Event | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd line NSCLC | Part 2 - Cohort B, 3rd line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 0/3 | 1/3 | 2/8 | 6/42 | 5/40 | 4/31 | 1/31 | 4/32 | 4/30 | 0/31 | 1/1 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 1/3 | 3/8 | 11/42 | 4/40 | 4/31 | 3/31 | 9/32 | 9/30 | 5/31 | 1/1 |
| Decreased appetiteMetabolism and nutrition disorders | 0/3 | 0/3 | 2/8 | 9/42 | 8/40 | 4/31 | 0/31 | 9/32 | 5/30 | 3/31 | 1/1 |
| HypokalaemiaMetabolism and nutrition disorders | 0/3 | 0/3 | 0/8 | 3/42 | 1/40 | 1/31 | 0/31 | 0/32 | 3/30 | 1/31 | 1/1 |
| PruritusSkin and subcutaneous tissue disorders | 0/3 | 2/3 | 1/8 | 5/42 | 2/40 | 3/31 | 2/31 | 3/32 | 7/30 | 2/31 | 1/1 |
| HypertensionVascular disorders | 2/3 | 2/3 | 5/8 | 10/42 | 9/40 | 4/31 | 8/31 | 4/32 | 13/30 | 4/31 | 1/1 |
| Abdominal pain upperGastrointestinal disorders | 0/3 | 0/3 | 0/8 | 2/42 | 5/40 | 2/31 | 0/31 | 1/32 | 3/30 | 1/31 | 1/1 |
| NauseaGastrointestinal disorders | 0/3 | 2/3 | 4/8 | 6/42 | 8/40 | 4/31 | 4/31 | 5/32 | 2/30 | 2/31 | 1/1 |
| Chest painGeneral disorders | 0/3 | 2/3 | 0/8 | 3/42 | 4/40 | 2/31 | 0/31 | 1/32 | 2/30 | 1/31 | 0/1 |
| HeadacheNervous system disorders | 0/3 | 2/3 | 1/8 | 4/42 | 4/40 | 1/31 | 4/31 | 4/32 | 5/30 | 0/31 | 0/1 |
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
| Age, Continuous(Years) | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd Line NSCLC | Part 2 - Cohort B, 3rd Line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, Glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC) | Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 56.3 ± 9.5 | 60.3 ± 2.1 | 58.3 ± 12.1 | 64.3 ± 9.1 | 59.2 ± 10.1 | 63.1 ± 11.7 | 56.7 ± 9.5 | 59.9 ± 14.7 | 64.4 ± 8.8 | 63.6 ± 9.4 | 55 ± na | 61.4 ± 10.8 |
| Sex: Female, Male(Participants) | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd Line NSCLC | Part 2 - Cohort B, 3rd Line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, Glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC) | Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 3 | 15 | 18 | 10 | 10 | 10 | 4 | 7 | 1 | 80 |
| Male | 2 | 2 | 5 | 27 | 22 | 21 | 21 | 22 | 26 | 24 | 0 | 172 |
| Ethnicity (NIH/OMB)(Participants) | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd Line NSCLC | Part 2 - Cohort B, 3rd Line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, Glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC) | Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
| Not Hispanic or Latino | 1 | 2 | 5 | 29 | 17 | 25 | 26 | 15 | 20 | 31 | 1 | 172 |
| Unknown or Not Reported | 2 | 1 | 3 | 13 | 23 | 5 | 4 | 16 | 10 | 0 | 0 | 77 |
| Race (NIH/OMB)(Participants) | Part 1 - BI 836880 360 mg | Part 1 - BI 836880 500 mg | Part 1 - BI 836880 720 mg | Part 2 - Cohort A, 2nd Line NSCLC | Part 2 - Cohort B, 3rd Line NSCLC | Part 2 - Cohort C, SCLC | Part 2 - Cohort D, Glioblastoma | Part 2 - Cohort E, Melanoma | Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma | Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC) | Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 10 | 3 | 4 | 6 | 4 | 8 | 4 | 0 | 39 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 1 | 2 | 5 | 19 | 14 | 24 | 20 | 12 | 12 | 25 | 1 | 135 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 | 13 | 23 | 3 | 4 | 16 | 10 | 0 | 0 | 75 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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: studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 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
Ran from Jul 2018 to primary completion in Jul 2024, 72 months.
Results were first posted in Nov 2025, 1 year 3 months after primary completion.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's 72 months is above that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BI-836880
Carcinoma, Non-Small-Cell Lung →