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Checkpoint Inhibitor

BI 754111 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
Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type) For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to see if they can help the immune system fight cancer in adults with advanced solid tumors.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have an advanced form of cancer that has spread and cannot be removed by surgery. You have already tried standard treatments or there are no proven treatments available for your type of cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part I - Maximum-tolerated dose (MTD) of the BI 754111 plus BI 754091 combination
Part I - Number of patients experiencing Dose-limiting toxicity (DLTs) during the combination Maximum-tolerated dose (MTD) evaluation period (first cycle of BI 754111 plus BI 754091 combination therapy) in patients with solid tumours
Part II - Objective response (OR) - confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as assessed by the Investigator during the entire treatment
Secondary outcome measures
Part I - AUC 0-504: Area under the Concentration Time Curve (AUC 0-504) of BI 754111/ BI 754091 in plasma over the time interval
Part I - Cmax: maximum measured concentration of BI 754111/ BI 754091 in plasma
Part I - Number of patients experiencing Dose-limiting toxicity (DLTs) from start of treatment until end of treatment (in all cycles)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part II - Dose-ExpansionExperimental Treatment2 Interventions
Group II: Part I - Dose--EscalationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 754111
2018
Completed Phase 1
~320
BI 754091
2018
Completed Phase 1
~490

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
11,338,806 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted clearance to BI 754111?

"Assessing the risk versus reward of BI 754111, our team gave it a rating of 1 due to limited clinical data supporting its safety and efficacy."

Answered by AI

Are there any opportunities currently available to participate in this experiment?

"Clinicaltrials.gov does not indicate that this trial is presently open to recruitment, given its last update was on November 15th 2022 since first being posted 6/13/2017. There are 3,664 other trials actively sourcing participants at the moment though."

Answered by AI

In what capacity is this clinical experiment being conducted across various facilities?

"As of right now, 8 sites are actively enrolling patients for this trial. Patients can find locations in Miami, Toronto and Hackensack as well as other cities across the United States. Therefore, to minimize travel needs during the study, it is essential to select a site that is close by."

Answered by AI
~22 spots leftby Mar 2025