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Monoclonal Antibodies
BI 836880 + Ezabenlimab for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Documented disease progression or relapse during or after completion of at least 2 cycles of platinum-based chemotherapy as first line treatment of Stage IIIB/IV non-squamous NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs, BI 836880 and ezabenlimab, to see if they can shrink tumors in people with advanced non-small cell lung cancer or other types of advanced cancer.
Who is the study for?
Adults with advanced non-small cell lung cancer and other advanced solid tumors, including liver cancer. Participants must have a life expectancy of at least 3 months, adequate organ function, and be willing to use effective birth control. They should not have had certain previous treatments or conditions that could affect the trial's outcomes.Check my eligibility
What is being tested?
The study tests two medicines: BI 836880 (an antibody blocking blood vessel formation in tumors) and ezabenlimab (boosting the immune system against cancer). The first part determined the highest tolerable dose; the second part assesses if this combination can shrink tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusions every three weeks, inflammation due to immune response changes, fatigue, digestive issues, and possibly increased risk of infections or blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signed and understand the consent form for this trial.
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My non-squamous NSCLC worsened after 2 rounds of platinum-based treatment.
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My advanced lung cancer tests positive for PDL-1.
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I have a measurable tumor outside my brain.
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I am using or willing to use effective birth control methods.
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I am fully active or can carry out light work.
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I have not been treated with checkpoint inhibitors or they were my last treatment before this trial.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of patients with Dose Limiting Toxicities (DLTs) within the first cycle of treatment
Part 2: Objective response
Secondary outcome measures
PART 2: Duration of objective response (DoR)
Part 1: Adverse events (AEs), drug related AEs, drug related AEs leading to discontinuation during treatment period
Part 1: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 504 hours (AUC 0-504h) after the first infusion cycle
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BI 836880 + ezabenlimabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 836880
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,040 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve damage.I have signed and understand the consent form for this trial.My non-squamous NSCLC worsened after 2 rounds of platinum-based treatment.I have an active hepatitis B or C infection.I have serious heart or brain blood vessel problems.I have had only one immunotherapy treatment before this study.I haven't had cancer treatment or radiotherapy in the last 28 days.I have brain metastases that cause symptoms or need treatment.I have had pneumonitis in the last 5 years.I haven't had cancer treatment in the last 28 days or within 5 half-lives of the drug.You have had serious allergic reactions to other types of antibodies.My organ functions are within normal ranges according to recent tests.I am not allergic to the trial drugs or their ingredients.Your heart's pumping function is less than 50%.I am willing and able to follow the study's requirements.I am not pregnant, nursing, or planning to become pregnant during the trial.I have fluid buildup that is not being managed by treatment.I have not received a live vaccine in the last 30 days.I have another cancer, but it's not spreading or serious like skin cancer.My advanced lung cancer tests positive for PDL-1.I have a measurable tumor outside my brain.I am willing to provide fresh tumor samples before and after treatment.I am using or willing to use effective birth control methods.I am legally an adult.I do not have any serious illnesses that would stop me from following the trial's requirements.I haven't had major surgery or a bone fracture in the last 4 weeks and don't plan any surgery during the trial.I or my family have a history of long QT syndrome, or I have a long QT interval.I have previously received treatment that stops the formation of new blood vessels in tumors.I have a tumor outside the brain that can be measured, or I have glioblastoma with a measurable brain tumor.I am fully active or can carry out light work.I need to take a full dose of blood thinner.I am using or willing to use effective birth control methods.I am legally an adult.I have had non-infectious lung inflammation in the past 5 years.I do not have HIV, hepatitis B, or hepatitis C.I am willing to provide a new tumor sample after my cancer has worsened or returned.My lesion is at least 2cm big and can be checked with a special MRI.I have not been treated with checkpoint inhibitors or they were my last treatment before this trial.I haven't taken high doses of steroids in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have not had severe bleeding or blood clot events in the last year.My high blood pressure is not under control.I have a genetic condition that affects my blood's ability to clot.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: BI 836880 + ezabenlimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participants in this research project?
"Per the information available on clinicaltrials.gov, this research study is no longer recruiting participants. It was initially posted in May 2018 and edited for the last time in November 2022. Fortunately, there are currently 4168 other medical trials that have open recruitment slots at present."
Answered by AI
Is BI 836880 a risk-free option for those seeking treatment?
"We assign BI 836880 a safety rating of 1, signifying that the drug is currently in Phase 1 clinical trials and hence possesses limited evidence for its efficacy or safety."
Answered by AI
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