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RECRUITING

NCT06452277

PHASE3

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Sponsor: Bayer

View on ClinicalTrials.gov

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 means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems 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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

444

Start Date

2024-08-28

Completion Date

2029-06-27

Last Updated

2026-11-04

Healthy Volunteers

Conditions

Advanced Non-small Cell Lung Cancer, HER2 Mutation

Interventions

DRUG

Sevabertinib

Tablet, oral

DRUG

Pembrolizumab

Intravenous (IV) infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Pemetrexed

IV infusion

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. 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 before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Locations (279)

Patty & George Hoag Cancer Center

Newport Beach, California, United States

UC San Diego Health - Moores Cancer Center

San Diego, California, United States

UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology

San Francisco, California, United States

UCLA Health Santa Monica Cancer Care

Santa Monica, California, United States

The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street

Fort Lauderdale, Florida, United States

Memorial Cancer Institute at Miramar

Miramar, Florida, United States

AdventHealth Cancer Institute Orlando

Orlando, Florida, United States

Moffitt Cancer Center - Magnolia Campus

Tampa, Florida, United States

Piedmont Healthcare - Atlanta

Atlanta, Georgia, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

University of Illinois Hospital - Outpatient Cancer Care Center

Chicago, Illinois, United States

The University of Chicago Medical Center - Hyde Park - Hematology & Oncology

Chicago, Illinois, United States

UM Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

UMass Memorial Medical Center - University Campus - Hematology/Oncology

Worcester, Massachusetts, United States

Profound Research -OMG - TriAtria Cancer Center

Farmington Hills, Michigan, United States

Profound Research - OMG - Royal Oak Cancer Center

Royal Oak, Michigan, United States

M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center

Minneapolis, Minnesota, United States

R.J. Zuckerberg Cancer Center

New Hyde Park, New York, United States

UC Medical Center - Oncology

Cincinnati, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Providence Cancer Institute - Franz Clinic

Portland, Oregon, United States

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University Hospital Simmons Cancer Center Lung/Head Neck Clinic

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, United States

Instituto Argentino de Diagnostico y Tratamiento (IADT)

TBC, Buenos Aires, Argentina

Centro de Investigaciones Clínicas, Clínica Viedma

Viedma, Río Negro Province, Argentina

Fundación Cenit para la Investigación en Neurociencias

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

Centro Médico Privado CEMAIC

Córdoba, Argentina

NSW Health - Blacktown Hospital

Blacktown, New South Wales, Australia

Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit

Concord, New South Wales, Australia

Calvary Mater Hospital Newcastle - Oncology

Waratah, New South Wales, Australia

University of the Sunshine Coast

Buderim, Queensland, Australia

Toowoomba Hospital Oncology Clinical Trials

Toowoomba, Queensland, Australia

Austin Hospital - Olivia Newton John Cancer Research Institute

Heidelberg, Victoria, Australia

Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III

Vienna, State of Salzburg, Austria

Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde

Vienna, State of Salzburg, Austria

Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie

Vienna, State of Vienna, Austria

Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik

Vienna, Austria

Antwerp University Hospital | Oncology Department

Antwerp, Antwerp, Belgium

UZ Leuven Gasthuisberg - Pneumology Department

Leuven, Flemish Brabant, Belgium

AZ Delta | Clinical Trial Center - Pneumology

Roeselare, West Flanders, Belgium

Pronutrir Fortaleza - CE

Fortaleza, Ceará, Brazil

Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima

Brasília, Federal District, Brazil

Rede DoR Recife - PE

Recife, Pernambuco, Brazil

Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Centro de Pesquisa da Clínica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

NAIC - Instituto do Cancer

Bauru, São Paulo, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

Jaú, São Paulo, Brazil

Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia

São José do Rio Preto, São Paulo, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante

São Paulo, Brazil

Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia

São Paulo, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology

São Paulo, Brazil

MHAT Uni Hospital

Panagyurishte, Pazardzhik Province, Bulgaria

MHAT "Heart and brain" Pleven

Pleven, Pleven Province, Bulgaria

Complex Oncology Center - Plovdiv EOOD

Plovdiv, Plovdiv Province, Bulgaria

MHAT Park Hospital EOOD

Plovdiv, Plovdiv Province, Bulgaria

MHAT Serdikamed

Sofia, Sofia City Province, Bulgaria

Multiprofile Hospital for Active Treatment "Sveta Sofia"

Sofia, Sofia City Province, Bulgaria

Specialized Hospital for Active Treatment of Oncology

Sofia, Sofia City Province, Bulgaria

University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia

Sofia, Sofia City Province, Bulgaria

MHAT Sveta Marina EAD

Varna, Varna Province, Bulgaria

BC Cancer | Vancouver

Vancouver, British Columbia, Canada

Brampton Civic Hospital | Oncology

Brampton, Ontario, Canada

Princess Margaret Cancer Centre | Medical Oncology and Hematology

Toronto, Ontario, Canada

Jewish General Hospital | Pulmonary Oncology

Montreal, Quebec, Canada

Cancer Hospital, Chinese Academy of Medical Sciences