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Intervention C - Intervention A - Intervention B for Non-Small Cell Lung Cancer

Phase 1
Recruiting
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
Female, of non-childbearing potential only
Must not have
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)
History of known or suspected malignant tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose on day 1, 4, 7 and 12. multiple post-dose time points on day 1-2, day 4-5, day 7-8 and day 12-13; one timepoint on day 3, day 6, day 9 and day 14
Awards & highlights

Summary

This trial is looking for a better way to treat advanced non-small cell lung cancer (NSCLC) in patients with specific genetic changes. The study will test a new treatment, BAY292708

Who is the study for?
Healthy participants are needed for a study on how food and Esomeprazole affect the blood levels of BAY2927088, a drug under development for advanced lung cancer with EGFR or HER2 mutations. Participants will undergo various meal conditions to assess drug absorption.
What is being tested?
The trial is testing how taking BAY2927088 with different meals (low-fat, high-fat, no meal) and alongside Esomeprazole affects its maximum concentration and total amount in the blood over time. The study involves four treatment periods across approximately eight weeks.
What are the potential side effects?
Potential side effects include any medical problems experienced during the trial. These could range from minor issues like headaches or nausea to more serious ones related to heart health or other organ functions as detected by physical exams and tests.

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 am a woman who cannot become pregnant.
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I am not pregnant or breastfeeding and cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant health issues like heart, liver, kidney diseases, diabetes, or seizures.
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I have had cancer or tumors suspected to be cancerous before.
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I haven't donated or lost more than 100 mL of blood in the last 4 weeks or 500 mL in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1, 4, 7 and 12. multiple post-dose time points on day 1-2, day 4-5, day 7-8 and day 12-13; one timepoint on day 3, day 6, day 9 and day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on day 1, 4, 7 and 12. multiple post-dose time points on day 1-2, day 4-5, day 7-8 and day 12-13; one timepoint on day 3, day 6, day 9 and day 14 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 for BAY2927088 in plasma
Cmax for BAY2927088 in plasma
Secondary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Intervention C - Intervention A - Intervention BExperimental Treatment3 Interventions
Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole.
Group II: Intervention B - Intervention C- Intervention AExperimental Treatment3 Interventions
Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole.
Group III: Intervention A - Intervention B - Intervention CExperimental Treatment3 Interventions
Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2927088
2024
Completed Phase 1
~30
Esomeprazole
2008
Completed Phase 4
~2670

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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
25,336,895 Total Patients Enrolled
~14 spots leftby Sep 2025
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