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)

August 18, 2026 updated by: Bayer

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

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.

Study Overview

Status

Recruiting

Conditions

Advanced Non-small Cell Lung Cancer, HER2 Mutation

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

444

Phase

Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Bayer Clinical Trials Contact
Phone Number: 18888422937
Email: clinical-trials-contact@bayer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1199ABB
    - Withdrawn
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, C1431FWO
    - Withdrawn
    - Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
  - Buenos Aires, Argentina, C1125 ABD
    - Withdrawn
    - Fundación CENIT para la Investigación en Neurociencias
  - Córdoba, Argentina, X5008HHW
    - Withdrawn
    - Centro Medico Privado CEMAIC
- Buenos Aires
  - TBC, Buenos Aires, Argentina, B1841
    - Withdrawn
    - Instituto Argentino de Diagnóstico y Tratamiento (IADT)
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, R8500ACE
    - Withdrawn
    - Centro de Investigaciones Clínicas, Clínica Viedma
Australia
- New South Wales
  - Blacktown, New South Wales, Australia, 2148
    - Recruiting
    - NSW Health - Blacktown Hospital
  - Concord, New South Wales, Australia, 2139
    - Recruiting
    - Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
  - Waratah, New South Wales, Australia, 2298
    - Recruiting
    - Calvary Mater Hospital Newcastle - Oncology
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Austin Hospital - Olivia Newton John Cancer Research Institute
Austria
- - Vienna, Austria, 1210
    - Recruiting
    - Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
- State of Salzburg
  - Vienna, State of Salzburg, Austria, 1090
    - Not yet recruiting
    - Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
  - Vienna, State of Salzburg, Austria, 1090
    - Not yet recruiting
    - Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
- State of Vienna
  - Vienna, State of Vienna, Austria, 1090
    - Not yet recruiting
    - Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
Belgium
- Antwerp
  - Antwerp, Antwerp, Belgium, 2650
    - Not yet recruiting
    - Antwerp University Hospital | Oncology Department
- Flemish Brabant
  - Leuven, Flemish Brabant, Belgium, 3000
    - Active, not recruiting
    - UZ Leuven Gasthuisberg - Pneumology Department
- West Flanders
  - Roeselare, West Flanders, Belgium, 8800
    - Active, not recruiting
    - AZ Delta | Clinical Trial Center - Pneumology
Brazil
- - São Paulo, Brazil, 01308-050
    - Recruiting
    - Hospital Sirio Libanes
  - São Paulo, Brazil, 01323-030
    - Recruiting
    - A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
  - São Paulo, Brazil, 71635-610
    - Not yet recruiting
    - Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
  - São Paulo, Brazil, 90020-090
    - Recruiting
    - Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
- Ceará
  - Fortaleza, Ceará, Brazil, 60810-180
    - Recruiting
    - Pronutrir Fortaleza - CE
- Federal District
  - Brasília, Federal District, Brazil, 04538-132
    - Recruiting
    - Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
- Pernambuco
  - Recife, Pernambuco, Brazil, 50070-480
    - Recruiting
    - Rede DoR Recife - PE
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59040-000
    - Recruiting
    - Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89010-340
    - Recruiting
    - Centro de Pesquisa da Clínica de Oncologia Reichow
- São Paulo
  - Bauru, São Paulo, Brazil, 17033-490
    - Recruiting
    - NAIC - Instituto do Câncer
  - Jaú, São Paulo, Brazil, 14784-400
    - Recruiting
    - Fundação Pio XII - Hospital de Câncer de Barretos
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Withdrawn
    - Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
Bulgaria
- Pazardzhik Province
  - Panagyurishte, Pazardzhik Province, Bulgaria, 4500
    - Not yet recruiting
    - MHAT Uni Hospital
- Pleven Province
  - Pleven, Pleven Province, Bulgaria, 5804
    - Not yet recruiting
    - MHAT "Heart and brain" Pleven
- Plovdiv Province
  - Plovdiv, Plovdiv Province, Bulgaria, 4109
    - Withdrawn
    - MHAT Park Hospital EOOD
  - Plovdiv, Plovdiv Province, Bulgaria, 4004
    - Not yet recruiting
    - Complex Oncology Center - Plovdiv EOOD
- Sofia City Province
  - Sofia, Sofia City Province, Bulgaria, 1404
    - Recruiting
    - Multiprofile Hospital for Active Treatment "Sveta Sofia"
  - Sofia, Sofia City Province, Bulgaria, 1797
    - Withdrawn
    - Specialized Hospital for Active Treatment of Oncology
  - Sofia, Sofia City Province, Bulgaria, 1303
    - Recruiting
    - MHAT Serdikamed
  - Sofia, Sofia City Province, Bulgaria, 1797
    - Not yet recruiting
    - University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
- Varna Province
  - Varna, Varna Province, Bulgaria, 9010
    - Not yet recruiting
    - MHAT Sveta Marina EAD
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Completed
    - BC Cancer | Vancouver
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - Brampton Civic Hospital | Oncology
  - Toronto, Ontario, Canada, M5G 2C4
    - Recruiting
    - Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Jewish General Hospital | Pulmonary Oncology
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Active, not recruiting
    - Beijing Cancer Hospital - Oncology Department
  - Beijing, Beijing Municipality, China, 100730
    - Active, not recruiting
    - Beijing Hospital
  - Beijing, Beijing Municipality, China, 100000
    - Not yet recruiting
    - Cancer Hospital, Chinese Academy of Medical Sciences
  - Beijing, Beijing Municipality, China, 100853
    - Not yet recruiting
    - The People's Liberation Army General Hospital (Beijing 301 Hospital)
  - Beijing, Beijing Municipality, China, 101149
    - Active, not recruiting
    - Beijing Chest Hospital, Capital Medical University
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Active, not recruiting
    - Fujian Cancer Hospital
  - Xiamen, Fujian, China, 361003
    - Active, not recruiting
    - Xiamen University - The First Affiliated Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510230
    - Active, not recruiting
    - The First Affiliated Hospital of Guangzhou Medical University
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Active, not recruiting
    - Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
- Heilongjiang
  - Harbin, Heilongjiang, China, 150000
    - Withdrawn
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, China, 430079
    - Active, not recruiting
    - Hubei Cancer Hospital
  - Wuhan, Hubei, China, 430023
    - Active, not recruiting
    - Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
- Hunan
  - Changsha, Hunan, China, 410013
    - Active, not recruiting
    - Hunan Cancer Hospital - Oncology Department
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Active, not recruiting
    - NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
  - Nanjing, Jiangsu, China, 210029
    - Active, not recruiting
    - Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
  - Taizhou, Jiangsu, China, 317000
    - Active, not recruiting
    - Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
- Jilin
  - Changchun, Jilin, China, 130000
    - Active, not recruiting
    - Jilin Cancer Hospital
- Shandong
  - Jinan, Shandong, China, 250117
    - Active, not recruiting
    - Shandong University - Shandong Cancer Hospital
  - Linyi, Shandong, China, 276001
    - Active, not recruiting
    - LinYi Cancer Hospital (Linyi Tumor Hospital)
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200030
    - Active, not recruiting
    - Shanghai Chest Hospital, Shanghai Jiaotong University
  - Shanghai, Shanghai Municipality, China, 200032
    - Active, not recruiting
    - Zhongshan Hospital, Fudan University
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Active, not recruiting
    - West China Hospital Sichuan University
  - Chengdu, Sichuan, China, 610041
    - Active, not recruiting
    - University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Active, not recruiting
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, China, 310016
    - Active, not recruiting
    - Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Czechia
- Moravian-Silesian Region
  - Nový Jičín, Moravian-Silesian Region, Czechia, 741 01
    - Not yet recruiting
    - Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
  - Ostrava - Vítkovice, Moravian-Silesian Region, Czechia, 703 00
    - Not yet recruiting
    - Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
- Olomouc Region
  - Olomouc, Olomouc Region, Czechia, 779 00
    - Withdrawn
    - Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
- South Moravian
  - Brno, South Moravian, Czechia, 602 00
    - Recruiting
    - Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
- Zlín
  - Zlín, Zlín, Czechia, 762 75
    - Not yet recruiting
    - Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
Denmark
- Capital Region / Region Hovedstaden
  - Copenhagen, Capital Region / Region Hovedstaden, Denmark, 2100
    - Active, not recruiting
    - Rigshospitalet Copenhagen University Hospital | Oncology Department
- Central Denmark Region / Region Midtjylland
  - Aarhus N, Central Denmark Region / Region Midtjylland, Denmark, 8200
    - Completed
    - Aarhus Universitetshospital
  - Herning, Central Denmark Region / Region Midtjylland, Denmark, 7400
    - Withdrawn
    - Regionshospitalet Gødstrup - Medicinsk afdeling
- North Denmark Region / Region Nordjylland
  - Aalborg, North Denmark Region / Region Nordjylland, Denmark, 9000
    - Completed
    - Aalborg University hospital - oncology department
- Region of Southern Denmark / Region Syddanmark
  - Odense, Region of Southern Denmark / Region Syddanmark, Denmark, 5000
    - Active, not recruiting
    - Odense University Hospital | Svendborg Sygehus - Oncology Department
Finland
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Withdrawn
    - Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00180
    - Recruiting
    - Docrates Mehiläinen Syöpäsairaala
France
- Auvergne-Rhône-Alpes
  - La Tronche, Auvergne-Rhône-Alpes, France, 38700
    - Active, not recruiting
    - Centre Hospitalier Michallon Grenoble - Service pneumologie
  - Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
    - Active, not recruiting
    - hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
- Brittany Region
  - Brest, Brittany Region, France, 29200
    - Active, not recruiting
    - Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
- Grand Est
  - Mulhouse, Grand Est, France, 68100
    - Withdrawn
    - hopital Emile Muller - Service Pneumologie
- Hauts-de-France
  - Lille, Hauts-de-France, France, 59000
    - Active, not recruiting
    - Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
- New Aquitaine
  - Bordeaux, New Aquitaine, France, 33076
    - Active, not recruiting
    - Institut Bergonie - Unicancer Nouvelle Aquitaine
  - Limoges, New Aquitaine, France, 87000
    - Active, not recruiting
    - Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
- Normandy
  - Rouen, Normandy, France, 76031
    - Withdrawn
    - CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
- Occitanie
  - Montpellier, Occitanie, France, 34091
    - Active, not recruiting
    - CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, France, 44093
    - Active, not recruiting
    - Hopital Nord Laennec - Oncologie medicale thoracique et digestive
  - Saint-Herblain, Pays de la Loire Region, France, 44800
    - Active, not recruiting
    - Institut de Cancerologie Ouest - Saint-Herblain
- Provence-Alpes-Côte d'Azur Region
  - Nice, Provence-Alpes-Côte d'Azur Region, France, 06100
    - Active, not recruiting
    - Centre Antoine Lacassagne - Departement Oncologie
- Île-de-France Region
  - Créteil, Île-de-France Region, France, 94010
    - Active, not recruiting
    - Centre Hospitalier Intercommunal Creteil - Service de pneumologie
  - Paris, Île-de-France Region, France, 75014
    - Withdrawn
    - APHP - Hopital Cochin - Service de Pneumologie
  - Paris, Île-de-France Region, France, 75248
    - Active, not recruiting
    - Institut Curie - Paris - Oncologie medicale
  - Suresnes, Île-de-France Region, France, 92150
    - Withdrawn
    - Hopital Foch - Oncologie digestive et thoracique
  - Villejuif, Île-de-France Region, France, 94800
    - Active, not recruiting
    - Gustave Roussy - Departement Oncologie-Radiotherapie
Germany
- - Berlin, Germany, 12203
    - Not yet recruiting
    - Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
- Baden-Wurttemberg
  - Stuttgart, Baden-Wurttemberg, Germany, 70376
    - Completed
    - Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
- Bavaria
  - Nuremberg, Bavaria, Germany, 90419
    - Active, not recruiting
    - Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60590
    - Not yet recruiting
    - Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
  - Giessen, Hesse, Germany, 35392
    - Not yet recruiting
    - Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Germany, 51109
    - Active, not recruiting
    - Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
  - Essen, North Rhine-Westphalia, Germany, 45147
    - Active, not recruiting
    - Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
  - Hemer, North Rhine-Westphalia, Germany, 58675
    - Active, not recruiting
    - Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
Greece
- - Athens, Greece, 11526
    - Active, not recruiting
    - Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
  - Athens, Greece, 11527
    - Active, not recruiting
    - Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
  - Athens, Greece, 11528
    - Active, not recruiting
    - General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
  - Athens, Greece, 12462
    - Active, not recruiting
    - University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
  - Larissa, Greece, 41110
    - Withdrawn
    - General University Hospital Of Larissa-Department of Medical Oncology
  - Piraeus, Greece, 18547
    - Withdrawn
    - Metropolitan Hospital- 4th Oncology Clinic
  - Pylaia Thessaloniki, Greece, 555 35
    - Withdrawn
    - Genesis Hospital- Department of Pathological Oncology
  - Thessaloniki, Greece, 57010
    - Active, not recruiting
    - Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
- Attica
  - Chaïdári, Attica, Greece, 12462
    - Withdrawn
    - University General Hospital Attikon-4th Department of Internal Medicine
Hong Kong
- - Kowloon, Hong Kong, 00000
    - Active, not recruiting
    - Hong Kong United Oncology Centre
- Hong Kong SAR
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Recruiting
    - Prince of Wales Hospital
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Recruiting
    - Queen Elizabeth Hospital Hong Kong
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Not yet recruiting
    - Queen Mary Hospital
Hungary
- - Budapest, Hungary, 1145
    - Withdrawn
    - Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
- Komárom-Esztergom
  - Tatabánya, Komárom-Esztergom, Hungary, 2800
    - Withdrawn
    - Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Israel
- - Ashdod, Israel, 7747629
    - Recruiting
    - Assuta Ashdod Public Hospital (R.A)
  - Beersheba, Israel, 8410101
    - Not yet recruiting
    - Soroka Medical Center- Legacy Heritage Cancer Center
  - Jerusalem, Israel, 91031
    - Recruiting
    - Shaare Zedek Medical Center (SZMC)
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Tel- Aviv Sourasky Medical Center - Nephrology
Italy
- - Avellino, Italy, 83100
    - Completed
    - AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
  - Aviano, Italy, 33081
    - Active, not recruiting
    - Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
  - Bologna, Italy, 40138
    - Active, not recruiting
    - Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
  - Florence, Italy, 50134
    - Active, not recruiting
    - Careggi University Hospital - Oncologia Clinica
  - Meldola, Italy, 47014
    - Active, not recruiting
    - Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
  - Milan, Italy, 20133
    - Active, not recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
  - Milan, Italy, 20132
    - Completed
    - Ospedale San Raffaele s.r.l. - Oncologia Medica
  - Milan, Italy, 20141
    - Active, not recruiting
    - Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
  - Orbassano, Italy, 10043
    - Active, not recruiting
    - Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
  - Padova, Italy, 35128
    - Active, not recruiting
    - Istituto Oncologico Veneto_Padova - UOC Oncologia 2
  - Palermo, Italy, 90146
    - Active, not recruiting
    - Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
  - Roma, Italy, 00144
    - Active, not recruiting
    - I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
  - Roma, Italy, 00168
    - Active, not recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
  - Rozzano, Italy, 20089
    - Active, not recruiting
    - Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
  - Verona, Italy, 37134
    - Withdrawn
    - Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
Japan
- - Fukuoka, Japan, 810-8563
    - Active, not recruiting
    - National Hospital Organization Kyushu Medical Center
  - Niigata, Japan, 951-8566
    - Active, not recruiting
    - Niigata Cancer Center Hospital
  - Osaka, Japan, 541-8567
    - Active, not recruiting
    - Osaka International Cancer Institute
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 460-0001
    - Active, not recruiting
    - National Hospital Organization Nagoya Medical Center
- Chiba
  - Kashiwa, Chiba, Japan, 277-8577
    - Active, not recruiting
    - National Cancer Center Hospital East
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
- Hyōgo
  - Himeji, Hyōgo, Japan, 670-8520
    - Not yet recruiting
    - National Hospital Organization Himeji Medical Center
  - Kobe, Hyōgo, Japan, 650-0017
    - Active, not recruiting
    - Kobe University Hospital
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0375
    - Active, not recruiting
    - Kitasato University Hospital
- Miyagi
  - Sendai, Miyagi, Japan, 980-0873
    - Active, not recruiting
    - Sendai Kousei Hospital
- Osaka
  - Hirakata, Osaka, Japan, 573-1191
    - Active, not recruiting
    - Kansai Medical University Hospital
  - Sakai, Osaka, Japan, 590-0197
    - Not yet recruiting
    - Kindai University Hospital
- Saitama
  - Kitaadachi, Saitama, Japan, 362-0806
    - Active, not recruiting
    - Saitama Cancer Center
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8603
    - Not yet recruiting
    - Nippon Medical School - Nippon Medical School Hospital - Cancer Center
- Tottori
  - Yonago, Tottori, Japan, 683-8504
    - Active, not recruiting
    - Tottori University Hospital
- Yamaguchi
  - Ube, Yamaguchi, Japan, 755-0241
    - Active, not recruiting
    - National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
Malaysia
- Kuala Lumpur
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
    - Active, not recruiting
    - Universiti Malaya Medical Centre
- Pulau Pinang
  - George Town, Pulau Pinang, Malaysia, 10050
    - Not yet recruiting
    - Gleneagles Penang Medical Center
  - Perai, Pulau Pinang, Malaysia, 13700
    - Active, not recruiting
    - Sunway Medical Centre Penang
- Selangor
  - Petaling Jaya, Selangor, Malaysia, 46050
    - Not yet recruiting
    - Beacon Hospital
  - Shah Alam, Selangor, Malaysia, 40460
    - Not yet recruiting
    - Columbia Asia Hospital Bukit Rimau
  - Subang Jaya, Selangor, Malaysia, 47500
    - Active, not recruiting
    - Sunway Medical Centre
Mexico
- - Mexico City, Mexico, 3810
    - Recruiting
    - ONCARE Viaducto Nápoles
  - Monterrey, Mexico, 64460
    - Recruiting
    - Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
  - Naucalpan, Mexico, 53100
    - Recruiting
    - Oncologia Integral Satelite
  - Puebla City, Mexico, 72530
    - Not yet recruiting
    - Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
  - San Pedro Garza García, Mexico, 66220
    - Recruiting
    - ONCARE Treatment Center
- Mexico City
  - Mexico City, Mexico City, Mexico, 14080
    - Recruiting
    - Instituto Nacional De Cancerologia
Netherlands
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6500 HB
    - Withdrawn
    - Radboud University Medical Center | Afdeling Interne Geneeskunde
- North Holland
  - Amsterdam, North Holland, Netherlands, 1066 CX
    - Active, not recruiting
    - Nederlands Kanker Instituut
Poland
- - Bialystok, Poland, 15-276
    - Withdrawn
    - Uniwersytecki Szpital Kliniczny w Bialymstoku
  - Kielce, Poland, 25-734
    - Not yet recruiting
    - Swietokrzyskie Centrum Onkologii
  - Lodz, Poland, 92-213
    - Completed
    - Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
  - Otwock, Poland, 05-400
    - Withdrawn
    - Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
  - Poznan, Poland, 60-569
    - Active, not recruiting
    - Wielkopolskie Centrum Pulmonologii i Torakochirurgii
  - Wroclaw, Poland, 53-413
    - Withdrawn
    - Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Portugal
- - Coimbra, Portugal, 3004-561
    - Not yet recruiting
    - Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
  - Lisbon, Portugal, 1400-038
    - Recruiting
    - Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
  - Lisbon, Portugal, 1769-001
    - Recruiting
    - CHULN - Hospital Pulido Valente
  - Porto, Portugal, 4200-072
    - Recruiting
    - Ipo Porto
- Porto District
  - Matosinhos Municipality, Porto District, Portugal, 4464-513
    - Recruiting
    - Hospital Pedro Hispano | Clinical Research Center
Romania
- - Bucharest, Romania, 30171
    - Completed
    - Spitalul Clinic Colțea
  - Bucharest, Romania, 22328
    - Active, not recruiting
    - Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
  - Cluj-Napoca, Romania, 400015
    - Not yet recruiting
    - CardioMed S.R.L.
  - Cluj-Napoca, Romania, 400015
    - Active, not recruiting
    - Institutul Oncologic Prof. Dr. Ion Chiricuta
  - Craiova, Romania, 200745
    - Active, not recruiting
    - Centrul de Oncologie Sfantul Nectarie
  - Ovidiu, Romania, 905900
    - Not yet recruiting
    - S.C Ovidius Clinical Hospital SRL - Oncology Department
  - Timișoara, Romania, 300166
    - Not yet recruiting
    - Oncocenter
- Comuna Floresti
  - Florești, Comuna Floresti, Romania, 407280
    - Active, not recruiting
    - Radiotherapy Center Cluj SRL
- Dolj
  - Craiova, Dolj, Romania, 200385
    - Not yet recruiting
    - Sc Oncolab Srl
Singapore
- - Singapore, Singapore, 308433
    - Completed
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 168583
    - Active, not recruiting
    - National Cancer Center Singapore - Oncology Department
  - Singapore, Singapore, 188770
    - Completed
    - Raffles Cancer Centre
  - Singapore, Singapore, 258499
    - Active, not recruiting
    - OncoCare Cancer Centre | Gleneagles Medical Centre
  - Singapore, Singapore, 329563
    - Completed
    - Curie Oncology | Farrer
Slovakia
- - Trnava, Slovakia, 917 75
    - Active, not recruiting
    - Fakultna nemocnica Trnava
South Korea
- - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital | Oncology
  - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center | Oncology
- Gyeonggi-do
  - Suwon, Gyeonggi-do, South Korea, 16247
    - Not yet recruiting
    - St Vincent's Hospital | Oncology
- Gyeongsangnam-do
  - Jinju, Gyeongsangnam-do, South Korea, 52727
    - Not yet recruiting
    - Gyeongsang National University Hospital | Oncology
  - Yangsan, Gyeongsangnam-do, South Korea, 50612
    - Recruiting
    - Pusan National University Yangsan Hospital | Pulmonology
- Jeollanam-do
  - Hwasun-gun, Jeollanam-do, South Korea, 58128
    - Not yet recruiting
    - Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
- North Chungcheong
  - Chungcheongbuk-do, North Chungcheong, South Korea, 28644
    - Not yet recruiting
    - Chungbuk National University Hospital | Hematology and Oncology
- Seoul
  - Jongno -Gu, Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital | Oncology
Spain
- - A Coruña, Spain, 15006
    - Withdrawn
    - Complexo Hospitalario Universitario A Coruna | Oncologia
  - Barcelona, Spain, 08028
    - Active, not recruiting
    - Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
  - Barcelona, Spain, 08035
    - Active, not recruiting
    - Hospital Universitari Vall D Hebron | Oncologia
  - Barcelona, Spain, 08036
    - Withdrawn
    - Hospital Clinic De Barcelona | Oncologia
  - Madrid, Spain, 28009
    - Not yet recruiting
    - Hospital General Universitario Gregorio Maranon | Oncologia
  - Madrid, Spain, 28034
    - Withdrawn
    - Hospital Universitario Ramon Y Cajal | Oncologia
  - Madrid, Spain, 28040
    - Withdrawn
    - Hospital Universitario Fundacion Jimenez Diaz | Oncologia
  - Valencia, Spain, 46026
    - Active, not recruiting
    - Hospital Universitario Y Politecnico La Fe | Oncologia
  - Valencia, Spain, 46009
    - Not yet recruiting
    - Fundacion Instituto Valenciano De Oncologia | Oncologia
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Active, not recruiting
    - Hospital Germans Trias I Pujol | Oncologia
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Active, not recruiting
    - Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Active, not recruiting
    - Hospital Universitario De Navarra | Oncologia
Sweden
- - Lund, Sweden, 221 85
    - Active, not recruiting
    - Skånes Universitetssjukhus - Lund - Lungmedicin
- Västerbotten County
  - Umeå, Västerbotten County, Sweden, 901 85
    - Completed
    - Norrlands Universitetssjukhus Umeå - Cancercentrum
Switzerland
- - Fribourg, Switzerland, 1708
    - Not yet recruiting
    - HFR Freiburg - Kantonsspital
- Canton of Aargau
  - Baden, Canton of Aargau, Switzerland, 5404
    - Recruiting
    - Kantonsspital Baden
Taiwan
- - Kaohsiung City, Taiwan, 807377
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital
  - Taichung, Taiwan, 402306
    - Recruiting
    - Chung Shan Medical University Hospital
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital
  - Tainan, Taiwan, 73657
    - Completed
    - Chi-Mei Medical Center, Liouyine
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 100225
    - Recruiting
    - National Taiwan University Hospital (NTUH) - Cancer Research Center
Turkey (Türkiye)
- - Istanbul, Turkey (Türkiye), 34899
    - Completed
    - Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  - Izmir, Turkey (Türkiye), 35100
    - Active, not recruiting
    - Ege Universitesi Tip Fakultesi Hastanesi
  - Küçükçekmece, Turkey (Türkiye), 34295
    - Not yet recruiting
    - İ.A.Ü. VM Medical Park Florya Hastanesi
  - Sakarya, Turkey (Türkiye), 54100
    - Not yet recruiting
    - Sakarya Universitesi Egitim ve Arastirma Hastanesi
  - Yenimahalle, Turkey (Türkiye), 6170
    - Not yet recruiting
    - Ankara Etlik Sehir Hastanesi
  - Yüreğir, Turkey (Türkiye), 1370
    - Completed
    - Adana Sehir Egitim ve Arastirma Hastanesi
- Ankara
  - Bilkent Çankaya, Ankara, Turkey (Türkiye), 6800
    - Active, not recruiting
    - Ankara Bilkent Sehir Hastanesi
- Istanbul
  - Kadıköy, Istanbul, Turkey (Türkiye), 34722
    - Active, not recruiting
    - İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
Ukraine
- - Dnipro, Ukraine, 49102
    - Not yet recruiting
    - LLC "RDP Ukraine" - Medical Department
  - Kropyvnytskyi, Ukraine, 25006
    - Not yet recruiting
    - Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
  - Kyiv, Ukraine, 03115
    - Not yet recruiting
    - Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
  - Kyiv, Ukraine, 3039
    - Not yet recruiting
    - Medical Center LLC "Verum Expert Clinic"
  - Kyiv, Ukraine, 03189
    - Recruiting
    - Limited Liability Company "MedOffice Group Medical Center"
  - Lutsk, Ukraine, 43018
    - Not yet recruiting
    - Regional Medical Oncology Centre_Oncology Chemotherapy Department
  - Rivne, Ukraine, 33010
    - Recruiting
    - Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
  - Uzhhorod, Ukraine, 88000
    - Not yet recruiting
    - MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
United Kingdom
- Devon
  - Torquay, Devon, United Kingdom, TQ2 7AA
    - Recruiting
    - Torbay Hospital | Oncology
- Northern Ireland
  - Belfast, Northern Ireland, United Kingdom, BT12 7AB
    - Withdrawn
    - Belfast City Hospital | Oncology
- Surrey
  - Guildford, Surrey, United Kingdom, GU2 7XX
    - Recruiting
    - Royal Surrey County Hospital | Cancer Centre
- Wales
  - Cardiff, Wales, United Kingdom, CF14 2TL
    - Not yet recruiting
    - Velindre Cancer Centre | Clinical Trials Unit
United States
- California
  - Newport Beach, California, United States, 92663
    - Withdrawn
    - Patty & George Hoag Cancer Center
  - San Diego, California, United States, 92037
    - Withdrawn
    - UC San Diego Health - Moores Cancer Center
  - San Francisco, California, United States, 94158
    - Recruiting
    - UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
  - Santa Monica, California, United States, 90404
    - Recruiting
    - UCLA Health Santa Monica Cancer Care
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Recruiting
    - The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
  - Miramar, Florida, United States, 33029
    - Completed
    - Memorial Cancer Institute at Miramar
  - Orlando, Florida, United States, 32804
    - Not yet recruiting
    - AdventHealth Cancer Institute Orlando
  - Tampa, Florida, United States, 33612
    - Not yet recruiting
    - Moffitt Cancer Center - Magnolia Campus
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Piedmont Healthcare - Atlanta
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - John B. Amos Cancer Center
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois Hospital - Outpatient Cancer Care Center
  - Chicago, Illinois, United States, 60637
    - Withdrawn
    - The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Not yet recruiting
    - UM Greenebaum Comprehensive Cancer Center
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - Withdrawn
    - UMass Memorial Medical Center - University Campus - Hematology/Oncology
- Michigan
  - Farmington Hills, Michigan, United States, 48334
    - Withdrawn
    - Profound Research -OMG - TriAtria Cancer Center
  - Royal Oak, Michigan, United States, 48073
    - Withdrawn
    - Profound Research - OMG - Royal Oak Cancer Center
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Not yet recruiting
    - M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
- New York
  - New Hyde Park, New York, United States, 11042
    - Withdrawn
    - R.J. Zuckerberg Cancer Center
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - UC Medical Center - Oncology
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Taylor Cancer Research Center
- Oregon
  - Portland, Oregon, United States, 97213
    - Not yet recruiting
    - Providence Cancer Institute - Franz Clinic
  - Portland, Oregon, United States, 97225
    - Not yet recruiting
    - Providence Oncology and Hematology Care Clinic Westside
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - Allegheny General Hospital
- Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - The University of Texas MD Anderson Cancer Center - Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sevabertinib Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.	Drug: Sevabertinib Tablet, oral
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. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.	Drug: Pembrolizumab Intravenous (IV) infusion Drug: Carboplatin IV infusion Drug: Pemetrexed IV infusion Drug: Cisplatin IV infusion

Participant Group / Arm

Intervention / Treatment

Experimental: Sevabertinib

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

Drug: Sevabertinib

Tablet, oral

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. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.

Drug: Pembrolizumab

Intravenous (IV) infusion

Drug: Carboplatin

IV infusion

Drug: Pemetrexed

IV infusion

Drug: Cisplatin

IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR Time Frame: Up to approximately 2 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR Time Frame: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator Time Frame: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR Time Frame: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator Time Frame: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Duration of response (DOR) as assessed by BICR Time Frame: Up to approximately 4 years	BICR = blinded independent central review (BICR)	Up to approximately 4 years
Duration of response (DOR) as assessed by the investigator Time Frame: Up to approximately 4 years		Up to approximately 4 years
Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity Time Frame: Up to approximately 4 years	CTCAE = common terminology criteria for adverse events; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event	Up to approximately 4 years
Change from baseline in NSCLC-SAQ total score Time Frame: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Change from baseline in NSCLC-SAQ individual domain scores Time Frame: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Time to deterioration in NSCLC-SAQ total score Time Frame: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Time to deterioration in NSCLC-SAQ individual domain scores Time Frame: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Time to deterioration in EORTC QLQ-C30 physical functioning domain score Time Frame: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30	Up to approximately 4 years
Change from baseline in EORTC QLQ-C30 physical functioning domain score Time Frame: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years
Change from baseline in EORTC QLQ-C30 global health status/QoL Time Frame: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years
Overall survival (OS) Time Frame: Up to approximately 4 years.		Up to approximately 4 years.
Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator Time Frame: Up to approximately 4 years		Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2024

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

June 27, 2029

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

July 24, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

22615
2024-511319-91-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product