Advanced Non-small Cell Lung CancerPhase 1NCT06348888
A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants
A Phase 1 study testing BAY2927088, Itraconazole and Carbamazepine in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 1 site in United States.
Trial summary
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation
- What is being tested?
- BAY2927088, Itraconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 12 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving signed informed consent as described in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), and in this protocol.
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, and cardiac examination.
- 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.
- Body mass index (BMI) within the range 18.0 to 30 kg/m2 (inclusive) at screening, with bodyweight above/equal to 50 kg.
- Female, of non childbearing potential only. Females must not be pregnant or breastfeeding, and must be documented as a woman of nonchildbearing potential. A negative pregnancy test is required.
- Male study participants of reproductive potential must agree to use adequate contraception when sexually active. From signing of the ICF until at least 3 months after the last dose of study intervention, and refrain from sperm donation during study intervention and for 6 months after the last dose of study intervention.
- Participant must be willing to comply with dietary and fluid requirements during the study period (including abstaining from alcohol use).
Who cannot join
- 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).
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal.
- Febrile illness within 4 weeks prior to admission to the clinic.
- Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator.
- A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator.
- Known severe allergies, allergies requiring therapy with corticosteroids, significant non-allergic drug reactions, or (multiple) drug allergies (excluding seasonal allergies such as non-severe hay fever that are asymptomatic and untreated during the time of study conduct).
Show all 10Show fewer
- Known history of hypersensitivity (or known allergic reaction) to BAY2927088 related compounds, or any components of the formulation, itraconazole or carbamazepine (HLA-A 31:01 or HLA-B 15:02 allele for Arm 2 only)
- History of known or suspected malignant tumors.
- Participants with any type of ongoing psychiatric disorder, especially any mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent.
- History of clinically relevant depression, or suicidal ideation or behavior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel Baltimore - Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.
Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.
Read more
In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.
BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.
The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine
- Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
The study will have 2 treatment groups.
In Group 1, participants will take:
- BAY2927088 as a single dose on Days 1 and 8.
- Itraconazole once daily on Days 5 to 11.
In Group 2, participants will take:
- BAY2927088 as a single dose on Days 1 and 14.
- Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.
Participants will visit the study clinic:
- at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
- on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
- once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up
During the study, the doctors and their study team will:
- perform physical examinations
- collect blood samples from the participants to measure the levels of BAY2927088
- check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
- Being tested
- BAY2927088, Itraconazole, Carbamazepine
- Keywords
- HER2 (Human epidermal growth factor receptor 2), EGFR (Epidermal growth factor receptor), NSCLC (Non-small cell lung cancer)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2927088Drug
Oral
ItraconazoleDrug
Capsule, 100 mg, oral.
CarbamazepineDrug
Tablet, 100 mg, 200mg and 300mg, oral.
| Study group | Role | What they receive |
|---|---|---|
| BAY2927088 + Itraconazole (ITZ) | Experimental | Participant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11. Receives: Drug: BAY2927088; Drug: Itraconazole |
| BAY2927088 + Carbamazepine (CBZ) | Experimental | Participant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15. Receives: Drug: BAY2927088; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of BAY2927088 with and without itraconazole
Measured: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
Cmax of BAY2927088 with and without itraconazole
Measured: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
AUC of BAY2927088 with and without carbamazepine
Measured: 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
Cmax of BAY2927088 with and without carbamazepine
Measured: 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
Secondary outcomes (2)
Number of participants with TEAEs
Measured: After the first administration of study intervention up to 7 days after the last administration of study intervention.
Severity of TEAEs
Measured: After the first administration of study intervention up to 7 days after the last administration of study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Apr 2024
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348888
- Sponsor's protocol ID
- 22250
- Status last verified
- Jun 2024
- First submitted
- 31 Mar 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06348888
- Acronym / sponsor ID
- 22250
- Keywords
- HER2 (Human epidermal growth factor receptor 2), EGFR (Epidermal growth factor receptor), NSCLC (Non-small cell lung cancer)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.
Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.
In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.
BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.
The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine
- Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
The study will have 2 treatment groups.
In Group 1, participants will take:
- BAY2927088 as a single dose on Days 1 and 8.
- Itraconazole once daily on Days 5 to 11.
In Group 2, participants will take:
- BAY2927088 as a single dose on Days 1 and 14.
- Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.
Participants will visit the study clinic:
- at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
- on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
- once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up
During the study, the doctors and their study team will:
- perform physical examinations
- collect blood samples from the participants to measure the levels of BAY2927088
- check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY2927088 + Itraconazole (ITZ) | Experimental | Drug: BAY2927088, Drug: ItraconazoleParticipant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11. |
| BAY2927088 + Carbamazepine (CBZ) | Experimental | Drug: BAY2927088, Drug: CarbamazepineParticipant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of giving signed informed consent as described in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), and in this protocol.
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, and cardiac examination.
- 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.
- Body mass index (BMI) within the range 18.0 to 30 kg/m2 (inclusive) at screening, with bodyweight above/equal to 50 kg.
Key exclusion criteria (10 listed)
- 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).
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal.
- Febrile illness within 4 weeks prior to admission to the clinic.
- Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator.
- A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2927088Oral | Drug | BAY2927088 + Carbamazepine (CBZ), BAY2927088 + Itraconazole (ITZ) |
| ItraconazoleCapsule, 100 mg, oral. | Drug | BAY2927088 + Itraconazole (ITZ) |
| CarbamazepineTablet, 100 mg, 200mg and 300mg, oral. | Drug | BAY2927088 + Carbamazepine (CBZ) |
Primary outcome
AUC of BAY2927088 with and without itraconazole
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
Cmax of BAY2927088 with and without itraconazole
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
AUC of BAY2927088 with and without carbamazepine
Time frame: 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
Cmax of BAY2927088 with and without carbamazepine
Time frame: 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
2 secondary outcomes
Number of participants with TEAEs
Time frame: After the first administration of study intervention up to 7 days after the last administration of study intervention.
Severity of TEAEs
Time frame: After the first administration of study intervention up to 7 days after the last administration of study intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Advanced Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2927088, Itraconazole and Carbamazepine in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of BAY2927088 with and without itraconazole (time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.