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Tyrosine Kinase Inhibitor
BAY2927088 for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver function as assessed by specific laboratory tests
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 1.5 years
Awards & highlights
Study Summary
This trial is studying a new way to treat non-small cell lung cancer.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have specific mutations in EGFR or HER2 genes. Participants must have a life expectancy of at least 12 weeks, measurable disease by scans, and adequate organ function. They should have progressed after prior therapy but can't join if they've had certain recent treatments, unresolved toxicities from past cancer treatment, HIV/Hepatitis B/C infection, brain metastases requiring treatment, or serious heart issues.Check my eligibility
What is being tested?
The study tests different formulations of BAY2927088 to find the safest dose that affects the body positively and determine how it's processed by the body. It involves three parts: increasing doses until safe limits are found (Dose Escalation), confirming these findings (Backfill), and giving an appropriate dose based on earlier results (Dose Expansion). Patients take the drug daily in cycles lasting three weeks each.See study design
What are the potential side effects?
As this is a first-in-human study for BAY2927088, all potential side effects aren't known yet. However, participants will be closely monitored for any adverse events such as changes in blood work results or physical symptoms that could indicate organ inflammation or other reactions to the new medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is working well, according to recent tests.
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I am fully active or can carry out light work.
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My blood tests show my bone marrow is working well.
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My cancer has a confirmed EGFR or HER2 mutation from a certified lab.
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My kidney function is within normal limits according to recent tests.
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My lung cancer is advanced but not treatable with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ about 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC(0-12) of BAY2927088 for BID
AUC(0-12)md of BAY2927088 for BID
AUC(0-24) of BAY2927088 for QD
+11 moreSecondary outcome measures
Disease control rate (DCR) per RECIST v1.1 by Investigator assessment and BICR in extension part
Duration of response (DOR) per RECIST 1.1 by Investigator assessment and BICR in extension part
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity in extension part
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Extension partExperimental Treatment2 Interventions
The enrollment of the Extension part may be initiated once all ongoing participants from the corresponding Expansion cohort (participants within the same Group) have at least 12 weeks of treatment (corresponding to 2 post-baseline efficacy assessments) or discontinue treatment.
Group II: Dose expansionExperimental Treatment2 Interventions
Dose Expansion is initiated after Dose Escalation and Backfill.
Group III: Dose escalationExperimental Treatment3 Interventions
Doses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD.
Group IV: BackfillExperimental Treatment3 Interventions
Dose Escalation and Backfill run concurrently
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,238 Previous Clinical Trials
25,332,258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that can be measured and has not been biopsied or treated with radiation.I have side effects from cancer treatment, but they are not severe except for hair loss or skin color changes.I have recent or available tumor tissue samples for testing.My liver is working well, according to recent tests.I have not had brain cancer or cancer spread to my brain that needed treatment.I am fully active or can carry out light work.I have had spinal cord compression or brain tumors, but with certain exceptions.I do not have HIV or active Hepatitis B or C.I have a serious heart condition that needs treatment.I haven't taken EGFR inhibitors recently.My blood tests show my bone marrow is working well.I haven't had cancer treatment, except for EGFR TKIs, in the last 14 days.My cancer has a confirmed EGFR or HER2 mutation from a certified lab.I have not had radiation or SRS within the last 14 days.My kidney function is within normal limits according to recent tests.I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days.I haven't had immunotherapy in the last 28 days.My lung cancer is advanced but not treatable with surgery or radiation.My condition worsened after at least one treatment for advanced disease, or I can't access/ tolerate standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Extension part
- Group 2: Backfill
- Group 3: Dose escalation
- Group 4: Dose expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have joined this research effort thus far?
"A total of 250 individuals, who meet the pre-set qualifications for this trial, are expected to partake in the study. Those interested may join from Roswell Park Comprehensive Cancer Center (Buffalo, New york) or Henry Ford Health System | Brigitte Harris Cancer Pavilion (Duarte, California)."
Answered by AI
Is enrollment still available for this trial?
"Affirmative. According to the clinicaltrials.gov website, this clinical trial is actively recruiting participants since its initial posting date on October 25th 2021 and last update on November 7th 2022. The study will include 250 individuals from a total of 7 different sites."
Answered by AI
How extensively is this clinical trial being conducted in the city?
"Seven medical centres are hosting this clinical trial, such as the Brigitte Harris Cancer Pavilion in Duarte and City of Hope National Medical Center in Houston. An additional four sites across America have been identified for participation."
Answered by AI
Has BAY2927088_formulation B_1 acquired the necessary certificates to be administered legally?
"Given the early stage of this trial, our team at Power assessed BAY2927088_formulation B_1's safety as a 1. This is because there is minimal data to support the efficacy and safety of this formulation."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
The drug I am on does not help with brain lesions and the next best choice may not be as effective with lung and bone cancer, but may help with the brain lesions. I am exploring my options.
PatientReceived 1 prior treatment
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