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BAY2927088 + Carbamazepine (CBZ) for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participant is a nonsmoker who has not used tobacco- or nicotine- containing products (eg., nicotine patch) for at least 6 months before administration of the first study intervention.
Must not have
History of known or suspected malignant tumors.
Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease, renal diseases), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose of day 1, multiple post-dose time points of days 1-3; pre-dose of day 14, multiple post-dose time points of days 14-16
Awards & highlights

Summary

This trial aims to find a better treatment for advanced non-small cell lung cancer (NSCLC) with specific genetic mutations. The study will test a new drug, BAY2927088, which

Who is the study for?
Healthy adults aged 18-55, non-smokers for at least 6 months, with a BMI of 18-30 and weight over/equal to 50 kg. Women must be of non-childbearing potential. Participants must agree to use contraception and avoid alcohol.
What is being tested?
The study tests how Itraconazole and Carbamazepine affect the blood levels of BAY2927088, a drug in development for advanced NSCLC with EGFR or HER2 mutations. It involves two groups taking different combinations and timings of these drugs.
What are the potential side effects?
Potential side effects are not specified but will be monitored through physical exams, blood/urine tests, ECGs, and participant feedback on any adverse events during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I haven't smoked or used nicotine products for at least 6 months.
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I am not pregnant or breastfeeding and cannot have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cancer.
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I have significant health issues like heart, liver, or kidney diseases.
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I am allergic to specific drugs or compounds related to the trial medication.
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I have a history of significant depression or thoughts of harming myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose of day 1, multiple post-dose time points of days 1-3; pre-dose of day 14, multiple post-dose time points of days 14-16
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose of day 1, multiple post-dose time points of days 1-3; pre-dose of day 14, multiple post-dose time points of days 14-16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC of BAY2927088 with and without carbamazepine
AUC of BAY2927088 with and without itraconazole
Cmax of BAY2927088 with and without carbamazepine
+1 more
Secondary outcome measures
Number of participants with TEAEs
Severity of TEAEs

Trial Design

2Treatment groups
Experimental Treatment
Group I: BAY2927088 + Itraconazole (ITZ)Experimental Treatment2 Interventions
Participant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11.
Group II: BAY2927088 + Carbamazepine (CBZ)Experimental Treatment2 Interventions
Participant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690
BAY2927088
2024
Completed Phase 1
~30
Itraconazole
2017
Completed Phase 2
~780

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,251 Previous Clinical Trials
25,336,886 Total Patients Enrolled
~20 spots leftby Sep 2025
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