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)
SOHO-02
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
2 other identifiers
interventional
555
35 countries
273
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2024
Longer than P75 for phase_3
273 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 27, 2029
September 23, 2026
September 9, 2026
3.2 years
June 5, 2024
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
Up to approximately 2 years
Secondary Outcomes (16)
Overall survival (OS)
Up to approximately 4 years.
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Up to approximately 4 years
Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator
Up to approximately 4 years
Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator
Up to approximately 4 years
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
Up to approximately 4 years
- +11 more secondary outcomes
Study Arms (2)
Sevabertinib
EXPERIMENTALParticipants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.
Standard of care (SoC)
ACTIVE COMPARATORParticipants 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. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (279)
Patty & George Hoag Cancer Center
Newport Beach, California, 92663, United States
UC San Diego Health - Moores Cancer Center
San Diego, California, 92037, United States
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
San Francisco, California, 94158, United States
UCLA Health Santa Monica Cancer Care
Santa Monica, California, 90404, United States
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
Fort Lauderdale, Florida, 33316, United States
Memorial Cancer Institute at Miramar
Miramar, Florida, 33029, United States
AdventHealth Cancer Institute Orlando
Orlando, Florida, 32804, United States
Moffitt Cancer Center - Magnolia Campus
Tampa, Florida, 33612, United States
Piedmont Healthcare - Atlanta
Atlanta, Georgia, 30318, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
University of Illinois Hospital - Outpatient Cancer Care Center
Chicago, Illinois, 60612, United States
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
Chicago, Illinois, 60637, United States
UM Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
UMass Memorial Medical Center - University Campus - Hematology/Oncology
Worcester, Massachusetts, 01655, United States
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, 48334, United States
Profound Research - OMG - Royal Oak Cancer Center
Royal Oak, Michigan, 48073, United States
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
Minneapolis, Minnesota, 55455, United States
R.J. Zuckerberg Cancer Center
New Hyde Park, New York, 11042, United States
UC Medical Center - Oncology
Cincinnati, Ohio, 45219, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
Providence Cancer Institute - Franz Clinic
Portland, Oregon, 97213, United States
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, 97225, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University Hospital Simmons Cancer Center Lung/Head Neck Clinic
Dallas, Texas, 75235, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, 77030, United States
Instituto Argentino de Diagnostico y Tratamiento (IADT)
TBC, Buenos Aires, B1841, Argentina
Centro de Investigaciones Clínicas, Clínica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Fundación Cenit para la Investigación en Neurociencias
Buenos Aires, C1125 ABD, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
Centro Médico Privado CEMAIC
Córdoba, X5008HHW, Argentina
NSW Health - Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
Concord, New South Wales, 2139, Australia
Calvary Mater Hospital Newcastle - Oncology
Waratah, New South Wales, 2298, Australia
University of the Sunshine Coast
Buderim, Queensland, 4556, Australia
Toowoomba Hospital Oncology Clinical Trials
Toowoomba, Queensland, 4350, Australia
Austin Hospital - Olivia Newton John Cancer Research Institute
Heidelberg, Victoria, 3084, Australia
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
Vienna, State of Salzburg, 1090, Austria
Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
Vienna, State of Salzburg, 1090, Austria
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
Vienna, State of Vienna, 1090, Austria
Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
Vienna, 1210, Austria
Antwerp University Hospital | Oncology Department
Antwerp, Antwerp, 2650, Belgium
UZ Leuven Gasthuisberg - Pneumology Department
Leuven, Flemish Brabant, 3000, Belgium
AZ Delta | Clinical Trial Center - Pneumology
Roeselare, West Flanders, 8800, Belgium
Pronutrir Fortaleza - CE
Fortaleza, Ceará, 60810-180, Brazil
Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
Brasília, Federal District, 04538-132, Brazil
Rede DoR Recife - PE
Recife, Pernambuco, 50070-480, Brazil
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
Natal, Rio Grande do Norte, 59040-000, Brazil
Centro de Pesquisa da Clínica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340, Brazil
NAIC - Instituto do Cancer
Bauru, São Paulo, 17033-490, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Jaú, São Paulo, 14784-400, Brazil
Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
São Paulo, 01323-030, Brazil
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
São Paulo, 71635-610, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
São Paulo, 90020-090, Brazil
MHAT Uni Hospital
Panagyurishte, Pazardzhik Province, 4500, Bulgaria
MHAT "Heart and brain" Pleven
Pleven, Pleven Province, 5804, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, Plovdiv Province, 4004, Bulgaria
MHAT Park Hospital EOOD
Plovdiv, Plovdiv Province, 4109, Bulgaria
MHAT Serdikamed
Sofia, Sofia City Province, 1303, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Sofia"
Sofia, Sofia City Province, 1404, Bulgaria
Specialized Hospital for Active Treatment of Oncology
Sofia, Sofia City Province, 1797, Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
Sofia, Sofia City Province, 1797, Bulgaria
MHAT Sveta Marina EAD
Varna, Varna Province, 9010, Bulgaria
BC Cancer | Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Brampton Civic Hospital | Oncology
Brampton, Ontario, L6R 3J7, Canada
Princess Margaret Cancer Centre | Medical Oncology and Hematology
Toronto, Ontario, M5G 2C4, Canada
Jewish General Hospital | Pulmonary Oncology
Montreal, Quebec, H3T 1E2, Canada
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000, China
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
The People's Liberation Army General Hospital (Beijing 301 Hospital)
Beijing, Beijing Municipality, 100853, China
Beijing chest hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Xiamen University - The First Affiliated Hospital
Xiamen, Fujian, 361003, China
The first Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510160, China
Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
Wuhan, Hubei, 430023, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
Taizhou, Jiangsu, 317000, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
Shandong University - Shandong Cancer Hospital
Jinan, Shandong, 250117, China
LinYi Cancer Hospital (Linyi Tumor Hospital)
Linyi, Shandong, 276001, China
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200030, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
Chengdu, Sichuan, 610041, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
Nový Jičín, Moravian-Silesian Region, 741 01, Czechia
Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
Ostrava - Vítkovice, Moravian-Silesian Region, 703 00, Czechia
Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
Olomouc, Olomouc Region, 779 00, Czechia
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
Brno, South Moravian, 602 00, Czechia
Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
Zlín, Zlín, 762 75, Czechia
Rigshospitalet Copenhagen University Hospital | Oncology Department
Copenhagen, Capital Region / Region Hovedstaden, 2100, Denmark
Aarhus Universitetshospital
Aarhus N, Central Denmark Region / Region Midtjylland, 8200, Denmark
Regionshospitalet Gødstrup - Medicinsk afdeling
Herning, Central Denmark Region / Region Midtjylland, 7400, Denmark
Aalborg Universitetshospital - Onkologisk afdeling
Aalborg, North Denmark Region / Region Nordjylland, 9000, Denmark
Odense University Hospital | Svendborg Sygehus - Oncology Department
Odense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark
Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
Turku, Southwest Finland, 20520, Finland
Docrates Mehiläinen Syöpäsairaala
Helsinki, Uusimaa, 00180, Finland
Centre Hospitalier Michallon Grenoble - Service pneumologie
La Tronche, Auvergne-Rhône-Alpes, 38700, France
hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
Brest, Brittany Region, 29200, France
hopital Emile Muller - Service Pneumologie
Mulhouse, Grand Est, 68100, France
Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
Lille, Hauts-de-France, 59000, France
Institut Bergonie - Unicancer Nouvelle Aquitaine
Bordeaux, New Aquitaine, 33076, France
Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
Limoges, New Aquitaine, 87000, France
CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
Rouen, Normandy, 76031, France
CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
Montpellier, Occitanie, 34091, France
Hopital Nord Laennec - Oncologie medicale thoracique et digestive
Nantes, Pays de la Loire Region, 44093, France
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, Pays de la Loire Region, 44800, France
Centre Antoine Lacassagne - Departement Oncologie
Nice, Provence-Alpes-Côte d'Azur Region, 06100, France
Centre Hospitalier Intercommunal Creteil - Service de pneumologie
Créteil, Île-de-France Region, 94010, France
APHP - Hopital Cochin - Service de Pneumologie
Paris, Île-de-France Region, 75014, France
Institut Curie - Paris - Oncologie medicale
Paris, Île-de-France Region, 75248, France
Hopital Foch - Oncologie digestive et thoracique
Suresnes, Île-de-France Region, 92150, France
Gustave Roussy - Departement Oncologie-Radiotherapie
Villejuif, Île-de-France Region, 94800, France
Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
Stuttgart, Baden-Wurttemberg, 70376, Germany
Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
Nuremberg, Bavaria, 90419, Germany
Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
Frankfurt am Main, Hesse, 60590, Germany
Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
Giessen, Hesse, 35392, Germany
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, 51109, Germany
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
Essen, North Rhine-Westphalia, 45147, Germany
Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
Hemer, North Rhine-Westphalia, 58675, Germany
Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Berlin, 12203, Germany
University General Hospital Attikon-4th Department of Internal Medicine
Chaïdári, Attica, 12462, Greece
Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
Athens, 11526, Greece
Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
Athens, 11527, Greece
General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
Athens, 11528, Greece
University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
Athens, 12462, Greece
General University Hospital Of Larissa-Department of Medical Oncology
Larissa, 41110, Greece
Metropolitan Hospital- 4th Oncology Clinic
Piraeus, 18547, Greece
Genesis Hospital- Department of Pathological Oncology
Pylaia Thessaloniki, 555 35, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
Thessaloniki, 57010, Greece
Prince of Wales Hospital
Hong Kong, Hong Kong SAR, 00000, Hong Kong
Queen Elizabeth Hospital Hong Kong
Hong Kong, Hong Kong SAR, 00000, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong SAR, 00000, Hong Kong
Hong Kong United Oncology Centre
Kowloon, 00000, Hong Kong
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, 2800, Hungary
Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
Budapest, 1145, Hungary
Assuta Ashdod Public Hospital (R.A)
Ashdod, 7747629, Israel
Soroka Medical Center- Legacy Heritage Cancer Center
Beersheba, 8410101, Israel
Shaare Zedek Medical Center (SZMC)
Jerusalem, 91031, Israel
Tel- Aviv Sourasky Medical Center - Nephrology
Tel Aviv, 6423906, Israel
AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
Avellino, 83100, Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
Aviano, 33081, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
Bologna, 40138, Italy
Careggi University Hospital - Oncologia Clinica
Florence, 50134, Italy
Ospedale Vito Fazzi Lecce - Oncologia
Lecce, 73100, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
Meldola, 47014, Italy
Ospedale San Raffaele s.r.l. - Oncologia Medica
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, 20133, Italy
Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
Milan, 20141, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
Orbassano, 10043, Italy
Istituto Oncologico Veneto_Padova - UOC Oncologia 2
Padova, 35128, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
Palermo, 90146, Italy
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
Roma, 00144, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
Roma, 00168, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, 20089, Italy
ASST Sette Laghi_Ospedale Macchi - Oncologia
Varese, 21100, Italy
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
Verona, 37134, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
National Hospital Organization Himeji Medical Center
Himeji, Hyōgo, 670-8520, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
Saitama Cancer Center
Kitaadachi, Saitama, 362-0806, Japan
Nippon Medical School - Nippon Medical School Hospital - Cancer Center
Bunkyo-ku, Tokyo, 113-8603, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
Ube, Yamaguchi, 755-0241, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Hospital Kebangsaan Malaysia
Cheras, Kuala Lumpur and Selangor, 56000, Malaysia
Gleneagles Penang Medical Center
George Town, Pulau Pinang, 10050, Malaysia
Sunway Medical Centre Penang
Perai, Pulau Pinang, 13700, Malaysia
Beacon Hospital
Petaling Jaya, Selangor, 46050, Malaysia
Columbia Asia Hospital Bukit Rimau
Shah Alam, Selangor, 40460, Malaysia
Sunway Medical Centre
Subang Jaya, Selangor, 47500, Malaysia
Instituto Nacional de Cancerología
Mexico City, Mexico City, 14080, Mexico
Oncare Viaducto Nápoles
Mexico City, 3810, Mexico
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
Monterrey, 64460, Mexico
Oncología Integral Satélite
Naucalpan, 53100, Mexico
Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
Puebla City, 72530, Mexico
ONCARE Treatment Center
San Pedro Garza García, 66220, Mexico
Radboud University Medical Center | Afdeling Interne Geneeskunde
Nijmegen, Gelderland, 6500 HB, Netherlands
Nederlands Kanker Instituut
Amsterdam, North Holland, 1066 CX, Netherlands
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
Warsaw, Masovian Voivodeship, 02-781, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Swietokrzyskie Centrum Onkologii
Kielce, 25-734, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
Lodz, 92-213, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
Otwock, 05-400, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, 60-569, Poland
Instytut Gruzlicy i Chorob Pluc
Warsaw, 01-138, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, 53-413, Poland
Hospital Pedro Hispano | Clinical Research Center
Matosinhos Municipality, Porto District, 4464-513, Portugal
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
Coimbra, 3004-561, Portugal
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
Lisbon, 1400-038, Portugal
CHULN - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
IPO Porto
Porto, 4200-072, Portugal
Radiotherapy Center Cluj SRL
Florești, Comuna Floresti, 407280, Romania
Sc Oncolab Srl
Craiova, Dolj, 200385, Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
Bucharest, 22328, Romania
Spitalul Clinic Coltea
Bucharest, 30171, Romania
CardioMed S.R.L.
Cluj-Napoca, 400015, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, 200745, Romania
S.C Ovidius Clinical Hospital SRL - Oncology Department
Ovidiu, 905900, Romania
Oncocenter
Timișoara, 300166, Romania
National Cancer Center Singapore - Oncology Department
Singapore, 168583, Singapore
Raffles Cancer Centre
Singapore, 188770, Singapore
OncoCare Cancer Centre | Gleneagles Medical Centre
Singapore, 258499, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Curie Oncology | Farrer
Singapore, 329563, Singapore
POKO Poprad s.r.o.
Poprad, Presov, 058 01, Slovakia
Fakultna nemocnica Trnava
Trnava, 917 75, Slovakia
St Vincent's Hospital | Oncology
Suwon, Gyeonggi-do, 16247, South Korea
Gyeongsang National University Hospital | Oncology
Jinju, Gyeongsangnam-do, 52727, South Korea
Pusan National University Yangsan Hospital | Pulmonology
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
Hwasun-gun, Jeollanam-do, 58128, South Korea
Chungbuk National University Hospital | Hematology and Oncology
Chungcheongbuk-do, North Chungcheong, 28644, South Korea
Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, 03080, South Korea
Severance Hospital | Oncology
Seoul, 03722, South Korea
Samsung Medical Center | Oncology
Seoul, 06351, South Korea
Hospital Germans Trias I Pujol | Oncologia
Badalona, Barcelona, 08916, Spain
Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
Majadahonda, Madrid, 28222, Spain
Hospital Universitario De Navarra | Oncologia
Pamplona, Navarre, 31008, Spain
Complexo Hospitalario Universitario A Coruna | Oncologia
A Coruña, 15006, Spain
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
Barcelona, 08028, Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035, Spain
Hospital Clinic De Barcelona | Oncologia
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Maranon | Oncologia
Madrid, 28009, Spain
Hospital Universitario Ramon Y Cajal | Oncologia
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
Madrid, 28040, Spain
Fundacion Instituto Valenciano De Oncologia | Oncologia
Valencia, 46009, Spain
Hospital Universitario Y Politecnico La Fe | Oncologia
Valencia, 46026, Spain
Norrlands Universitetssjukhus Umeå - Cancercentrum
Umeå, Västerbotten County, 901 85, Sweden
Skånes Universitetssjukhus - Lund - Lungmedicin
Lund, 221 85, Sweden
Kantonsspital Baden
Baden, Canton of Aargau, 5404, Switzerland
HFR Freiburg - Kantonsspital
Fribourg, 1708, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377, Taiwan
Chung Shan Medical University Hospital
Taichung, 402306, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi-Mei Medical Center, Liouyine
Tainan, 73657, Taiwan
National Taiwan University Hospital (NTUH) - Cancer Research Center
Taipei, 100225, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ankara Bilkent Sehir Hastanesi
Bilkent Çankaya, Ankara, 6800, Turkey (Türkiye)
İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
Kadıköy, Istanbul, 34722, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
İ.A.Ü. VM Medical Park Florya Hastanesi
Küçükçekmece, 34295, Turkey (Türkiye)
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Sakarya, 54100, Turkey (Türkiye)
Ankara Etlik Sehir Hastanesi
Yenimahalle, 6170, Turkey (Türkiye)
Adana Sehir Egitim ve Arastirma Hastanesi
Yüreğir, 1370, Turkey (Türkiye)
LLC "RDP Ukraine" - Medical Department
Dnipro, 49102, Ukraine
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
Kropyvnytskyi, 25006, Ukraine
Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
Kyiv, 03115, Ukraine
Limited Liability Company "MedOffice Group Medical Center"
Kyiv, 03189, Ukraine
Medical Center LLC "Verum Expert Clinic"
Kyiv, 3039, Ukraine
Regional Medical Oncology Centre_Oncology Chemotherapy Department
Lutsk, 43018, Ukraine
Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
Rivne, 33010, Ukraine
MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
Uzhhorod, 88000, Ukraine
Torbay Hospital | Oncology
Torquay, Devon, TQ2 7AA, United Kingdom
Belfast City Hospital | Oncology
Belfast, Northern Ireland, BT12 7AB, United Kingdom
Royal Surrey County Hospital | Cancer Centre
Guildford, Surrey, GU2 7XX, United Kingdom
Velindre Cancer Centre | Clinical Trials Unit
Cardiff, Wales, CF14 2TL, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 11, 2024
Study Start
August 28, 2024
Primary Completion (Estimated)
October 28, 2027
Study Completion (Estimated)
June 27, 2029
Last Updated
September 23, 2026
Record last verified: 2026-09-09
Data Sharing
- IPD Sharing
- Will not share
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.