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NCT03156114 · ClinicalTrials.gov registry record · Phase 1
This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 172
- Enrollment target
NCT03156114 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 172 participants.
The verdict
NCT03156114, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 172 participants
- Enrollment target
Study Summary
This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors. The study has two parts. In the first part, doctors want to find out the highest dose of 2 medicines that people with solid tumors can tolerate. This dose is then used for the second part of the study. In the second part, the combination of the two medicines is tested in patients with non-small cell lung cancer and other types of solid cancer. These patients had gotten treatment with anti-PD-1 or anti-PD-L1 medicines but their tumors have come back. The doctors check whether the combination of BI 754111 and BI 754091 makes tumors shrink. Both medicines are given as an infusion into the vein every 3 weeks. If there is benefit for the patients and if they can tolerate it, the treatment is given for maximum of 1 year. During the entire study doctors will regularly check the health of the patients.
Interventions
- DRUG Ezabenlimab
- DRUG BI 754111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2023-06-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03156114
The ClinicalTrials.gov registry entry for NCT03156114 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ezabenlimab is the first listed.
NCT03156114 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03156114 about?
NCT03156114 is a clinical study titled "This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.". This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors. The study has two ...
What is the current status of trial NCT03156114?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 172 participants. The study started on 2017-06-13. Estimated completion is 2023-06-06.
What interventions are being tested in trial NCT03156114?
The interventions under investigation include: Ezabenlimab (DRUG), BI 754111 (DRUG).
Who is sponsoring clinical trial NCT03156114?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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