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NCT03468426 · ClinicalTrials.gov registry record · Phase 1
A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 252
- Enrollment target
NCT03468426: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT03468426 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 252 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (320% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03468426, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 252 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.
Interventions
- DRUG Ezabenlimab
- DRUG BI 836880
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 1 |
What the finished NCT03468426 record still lists
NCT03468426 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (320% higher).
The record links to 0 conditions, and to 2 interventions - of which Ezabenlimab is the first listed.
NCT03468426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03468426 about?
NCT03468426 is a clinical study titled "A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours". 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...
What is the current status of trial NCT03468426?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 252 participants. The study started on 2018-07-05. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT03468426?
The interventions under investigation include: Ezabenlimab (DRUG), BI 836880 (DRUG).
Who is sponsoring clinical trial NCT03468426?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03468426's enrollment target sits among peer trials
252 169th of 2000 higher than 1,829 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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