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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06452277




Registration number
NCT06452277
Ethics application status
Date submitted
5/06/2024
Date registered
11/06/2024
Date last updated
15/10/2024

Titles & IDs
Public title
A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)
Scientific title
A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations
Secondary ID [1] 0 0
2024-511319-91-00
Secondary ID [2] 0 0
22615
Universal Trial Number (UTN)
Trial acronym
SOHO-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Non-small Cell Lung Cancer 0 0
HER2 Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY2927088
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed

Experimental: BAY2927088 - Participants will receive BAY2927088 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.

Active comparator: Standard of care (SoC) - Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.


Treatment: Drugs: BAY2927088
Tablet, oral

Treatment: Drugs: Pembrolizumab
Intravenous (IV) infusion

Treatment: Drugs: Cisplatin
IV infusion

Treatment: Drugs: Carboplatin
IV infusion

Treatment: Drugs: Pemetrexed
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Objective Response Rate (ORR) as assessed by the investigator
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Duration of response (DOR) as assessed by BICR
Timepoint [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Duration of response (DOR) as assessed by the investigator
Timepoint [8] 0 0
Up to approximately 4 years
Secondary outcome [9] 0 0
Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Change from baseline in NSCLC-SAQ total score
Timepoint [10] 0 0
Up to approximately 4 years
Secondary outcome [11] 0 0
Change from baseline in NSCLC-SAQ individual domain scores
Timepoint [11] 0 0
Up to approximately 4 years
Secondary outcome [12] 0 0
Time to deterioration in NSCLC-SAQ total score
Timepoint [12] 0 0
Up to approximately 4 years
Secondary outcome [13] 0 0
Time to deterioration in NSCLC-SAQ individual domain scores
Timepoint [13] 0 0
Up to approximately 4 years
Secondary outcome [14] 0 0
Time to deterioration in EORTC QLQ-C30 physical functioning domain score
Timepoint [14] 0 0
Up to approximately 4 years
Secondary outcome [15] 0 0
Change from baseline in EORTC QLQ-C30 physical functioning domain score
Timepoint [15] 0 0
Up to approximately 4 years
Secondary outcome [16] 0 0
Change from baseline in EORTC QLQ-C30 global health status/QoL
Timepoint [16] 0 0
Up to approximately 4 years

Eligibility
Key inclusion criteria
* Participant must be =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
* Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
* Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
* No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
* Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:

* a. in situ cancers of cervix, breast, or skin,
* b. superficial bladder cancer (Ta, Tis and T1),
* c. limited-stage prostate cancer,
* d. basal or squamous cancers of the skin.
* Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
* Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention.
* Pre-existing peripheral neuropathy that is Grade =2 by CTCAE (v5.0).
* History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
* Prior radiotherapy outside of the brain within 21 days of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2028
Actual
Sample size
Target
278
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Cancer & Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit - Concord
Recruitment hospital [3] 0 0
Calvary Mater Hospital Newcastle - Waratah
Recruitment hospital [4] 0 0
University of the Sunshine Coast - Buderim
Recruitment hospital [5] 0 0
The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC) - Garran
Recruitment hospital [6] 0 0
Austin Hospital - Olivia Newton John Cancer Research Institute - Heidelberg
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4556 - Buderim
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 human epidermal growth factor receptor 2 (HER2) mutations.

Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.

The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.

The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.

The study participants will receive one of the study treatments:

* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.

During the study, the doctors and their study team will:

* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* 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. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Trial website
https://clinicaltrials.gov/study/NCT06452277
Trial related presentations / publications
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06452277