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)

November 3, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Médico Privado CEMAIC
    • Buenos Aires
      • TBC, Buenos Aires, Argentina, B1841
        • Withdrawn
        • Instituto Argentino de Diagnostico 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
        • Active, not recruiting
        • NSW Health - Blacktown Hospital
      • Concord, New South Wales, Australia, 2139
        • Completed
        • Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
      • Waratah, New South Wales, Australia, 2298
        • Active, not recruiting
        • Calvary Mater Hospital Newcastle - Oncology
    • Queensland
      • Buderim, Queensland, Australia, 4556
        • Withdrawn
        • University of the Sunshine Coast
      • Toowoomba, Queensland, Australia, 4350
        • Withdrawn
        • Toowoomba Hospital Oncology Clinical Trials
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Active, not recruiting
        • Austin Hospital - Olivia Newton John Cancer Research Institute
  • Austria
      • Vienna, Austria, 1210
        • Active, not recruiting
        • Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
    • State of Salzburg
      • Vienna, State of Salzburg, Austria, 1090
        • Withdrawn
        • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
      • Vienna, State of Salzburg, Austria, 1090
        • Withdrawn
        • Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Withdrawn
        • Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
  • Belgium
    • Antwerp
      • Antwerp, Antwerp, Belgium, 2650
        • Withdrawn
        • 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, 01323-030
        • Recruiting
        • A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
      • São Paulo, Brazil, 90020-090
        • Recruiting
        • Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
      • São Paulo, Brazil, 01308-050
        • Recruiting
        • Hospital Sirio Libanes
      • São Paulo, Brazil, 71635-610
        • Withdrawn
        • Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
    • 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 Cancer
      • Jaú, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundacao Pio XII - Hospital de Cancer 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, 1797
        • Not yet recruiting
        • University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
      • Sofia, Sofia City Province, Bulgaria, 1303
        • Active, not recruiting
        • MHAT Serdikamed
    • 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 | 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, 100853
        • Not yet recruiting
        • The People's Liberation Army General Hospital (Beijing 301 Hospital)
      • Beijing, Beijing Municipality, China, 100021
        • Not yet recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • 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
        • Completed
        • Xiamen University - The First Affiliated Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510160
        • 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, 210029
        • Active, not recruiting
        • Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210008
        • Active, not recruiting
        • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
      • 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
        • Withdrawn
        • Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
      • Ostrava - Vítkovice, Moravian-Silesian Region, Czechia, 703 00
        • Withdrawn
        • 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
        • Withdrawn
        • 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
        • Withdrawn
        • Aalborg Universitetshospital - Onkologisk afdeling
    • 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
        • Withdrawn
        • Docrates Mehiläinen Syöpäsairaala
  • France
    • Auvergne-Rhône-Alpes
      • La Tronche, Auvergne-Rhône-Alpes, France, 38700
        • Completed
        • 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
        • University General Hospital Of Larissa | 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
      • Jerusalem, Israel, 91031
        • Active, not recruiting
        • Shaare Zedek Medical Center - Oncology Institute
      • Tel Aviv, Israel, 6423906
        • Completed
        • Tel Aviv Sourasky Medical Center - Oncology Department
    • Central District
      • Ashdod, Central District, Israel, 7747629
        • Active, not recruiting
        • Assuta Ashdod Public Hospital (R.A)
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Completed
        • Clalit Health | Soroka Medical Center - Oncology department
  • Italy
    • Apulia
      • Lecce, Apulia, Italy, 73100
        • Withdrawn
        • Ospedale Vito Fazzi Lecce - Oncologia
    • Campania
      • Avellino, Campania, Italy, 83100
        • Completed
        • AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
      • Meldola, Emilia-Romagna, Italy, 47014
        • Active, not recruiting
        • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Active, not recruiting
        • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
    • Lazio
      • Rome, Lazio, Italy, 00144
        • Active, not recruiting
        • I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
      • Rome, Lazio, Italy, 00168
        • Active, not recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Completed
        • Ospedale San Raffaele s.r.l. - Oncologia Medica
      • Milan, Lombardy, Italy, 20133
        • Active, not recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
      • Milan, Lombardy, Italy, 20141
        • Active, not recruiting
        • Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
      • Rozzano, Lombardy, Italy, 20089
        • Active, not recruiting
        • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
      • Varese, Lombardy, Italy, 21100
        • Withdrawn
        • ASST Sette Laghi_Ospedale Macchi - Oncologia
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Active, not recruiting
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Active, not recruiting
        • Careggi University Hospital - Oncologia Clinica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Active, not recruiting
        • Istituto Oncologico Veneto_Padova - UOC Oncologia 2
      • Verona, Veneto, 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
    • Kuala Lumpur and Selangor
      • Cheras, Kuala Lumpur and Selangor, Malaysia, 56000
        • Withdrawn
        • University Hospital Kebangsaan Malaysia
    • 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
      • Puebla City, Mexico, 72530
        • Not yet recruiting
        • Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Completed
        • Instituto Nacional de Cancerología
      • Mexico City, Mexico City, Mexico, 3810
        • Active, not recruiting
        • Oncare Viaducto Nápoles
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
      • San Pedro Garza García, Nuevo León, Mexico, 66220
        • Active, not recruiting
        • ONCARE Treatment Center
    • State of Mexico
      • Naucalpan, State of Mexico, Mexico, 53100
        • Active, not recruiting
        • Oncología Integral Satélite
  • 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
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Active, not recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-413
        • Withdrawn
        • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
    • Masovian Voivodeship
      • Otwock, Masovian Voivodeship, Poland, 05-400
        • Withdrawn
        • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Withdrawn
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Withdrawn
        • Instytut Gruzlicy i Chorob Pluc
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Withdrawn
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 92-213
        • Completed
        • Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Withdrawn
        • Swietokrzyskie Centrum Onkologii
  • Portugal
      • Lisbon, Portugal, 1769-001
        • Recruiting
        • CHULN - Hospital Pulido Valente
      • Lisbon, Portugal, 1400-038
        • Completed
        • Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
      • Porto, Portugal, 4200-072
        • Recruiting
        • IPO Porto
    • Beira Litoral
      • Coimbra, Beira Litoral, Portugal, 3004-561
        • Completed
        • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
    • Porto District
      • Matosinhos Municipality, Porto District, Portugal, 4464-513
        • Recruiting
        • Hospital Pedro Hispano | Clinical Research Center
  • Romania
    • Bucharest Municipality
      • Bucharest, Bucharest Municipality, Romania, 22328
        • Active, not recruiting
        • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
      • Bucharest, Bucharest Municipality, Romania, 30171
        • Withdrawn
        • Spitalul Clinic Coltea
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Withdrawn
        • CardioMed S.R.L.
      • Cluj-Napoca, Cluj, Romania, 400015
        • Active, not recruiting
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
    • Comuna Floresti
      • Florești, Comuna Floresti, Romania, 407280
        • Active, not recruiting
        • Radiotherapy Center Cluj SRL
    • Constanța County
      • Ovidiu, Constanța County, Romania, 905900
        • Withdrawn
        • S.C Ovidius Clinical Hospital SRL - Oncology Department
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • Withdrawn
        • Sc Oncolab Srl
      • Craiova, Dolj, Romania, 200745
        • Active, not recruiting
        • Centrul de Oncologie Sfantul Nectarie
    • Timiș County
      • Timișoara, Timiș County, Romania, 300166
        • Withdrawn
        • Oncocenter
  • 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
        • Completed
        • Fakultna nemocnica Trnava
    • Presov
      • Poprad, Presov, Slovakia, 058 01
        • Withdrawn
        • POKO Poprad s.r.o.
  • 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
        • Terminated
        • 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, 28034
        • Withdrawn
        • Hospital Universitario Ramon Y Cajal | Oncologia
      • Madrid, Spain, 28040
        • Withdrawn
        • Hospital Universitario Fundacion Jimenez Diaz | Oncologia
      • Madrid, Spain, 28009
        • Withdrawn
        • Hospital General Universitario Gregorio Maranon | Oncologia
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Universitario Y Politecnico La Fe | Oncologia
      • Valencia, Spain, 46009
        • Withdrawn
        • 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
        • Withdrawn
        • HFR Freiburg - Kantonsspital
    • Canton of Aargau
      • Baden, Canton of Aargau, Switzerland, 5404
        • Active, not recruiting
        • Kantonsspital Baden
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Completed
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 402306
        • Active, not recruiting
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • Active, not 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
        • Active, not 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
      • Sakarya, Turkey (Türkiye), 54100
        • Not yet recruiting
        • Sakarya Universitesi Egitim ve Arastirma Hastanesi
    • Adana
      • Yüreğir, Adana, Turkey (Türkiye), 1370
        • Completed
        • Adana Sehir Egitim ve Arastirma Hastanesi
    • Aksaray
      • Bilkent Ankara, Aksaray, Turkey (Türkiye), 6800
        • Active, not recruiting
        • Ankara Bilkent Sehir Hastanesi
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 6170
        • Not yet recruiting
        • Ankara Etlik Sehir Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turkey (Türkiye), 34722
        • Active, not recruiting
        • İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
      • Küçükçekmece, Istanbul, Turkey (Türkiye), 34295
        • Not yet recruiting
        • İ.A.Ü. VM Medical Park Florya Hastanesi
  • Ukraine
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
        • Not yet recruiting
        • LLC "RDP Ukraine" - Medical Department
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
        • Not yet recruiting
        • Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
    • Kyiv City
      • Kyiv, Kyiv City, Ukraine, 03115
        • Not yet recruiting
        • Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
      • Kyiv, Kyiv City, Ukraine, 03189
        • Active, not recruiting
        • Limited Liability Company "MedOffice Group Medical Center"
      • Kyiv, Kyiv City, Ukraine, 3039
        • Not yet recruiting
        • Medical Center LLC "Verum Expert Clinic"
    • Rivne Oblast
      • Rivne, Rivne Oblast, Ukraine, 33010
        • Active, not recruiting
        • Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43018
        • Not yet recruiting
        • Regional Medical Oncology Centre_Oncology Chemotherapy Department
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Not yet recruiting
        • MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Active, not 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
        • Active, not recruiting
        • Royal Surrey County Hospital | Cancer Centre
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Withdrawn
        • 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
        • Withdrawn
        • Memorial Cancer Institute at Miramar
      • Orlando, Florida, United States, 32804
        • Not yet recruiting
        • AdventHealth Cancer Institute Orlando
      • Tampa, Florida, United States, 33612
        • Withdrawn
        • 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
        • Withdrawn
        • 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
        • Withdrawn
        • Providence Cancer Institute - Franz Clinic
      • Portland, Oregon, United States, 97225
        • Withdrawn
        • Providence Oncology and Hematology Care Clinic Westside
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • Withdrawn
        • University Hospital Simmons Cancer Center Lung/Head Neck Clinic
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Cisplatin

IV infusion

Drug: Carboplatin

IV infusion

Drug: Pemetrexed

IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) as assessed by the investigator
Time Frame: Up to approximately 4 years
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
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
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 15, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22615
  • 2024-511319-91-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

No

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.

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