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)

May 15, 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 is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.

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

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

The study participants will receive one of the study treatments:

  • Sevabertinib twice every day as a tablet by mouth, or
  • Standard treatment in cycles of 21 days via infusion ("drip") into the vein.
  • 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 receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the opportunity to switch ("cross over") to receive sevabertinib.
  • 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 doctors and their study team will:

  • take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
  • check the overall health of the participants by performing tests such as blood and urine tests, and checking
  • heart health using an electrocardiogram (ECG)
  • perform pregnancy tests for women
  • ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Study Overview

Status

Recruiting

Conditions

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

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)
      • Córdoba, Argentina, X5008HHW
        • Withdrawn
        • Centro Medico Privado CEMAIC
      • TBC, Argentina, TBC
        • Withdrawn
        • Instituto Argentino de Diagnóstico y Tratamiento (IADT)
      • Viedma, Argentina, R8500
        • Withdrawn
        • Centro de Investigaciones Clínicas, Clínica Viedma
    • Ciudad Auton. de Buenos Aires
      • CABA, Ciudad Auton. de Buenos Aires, Argentina, C1125 ABD
        • Withdrawn
        • Fundacion CENIT para la investigación en Neurociencias
  • Australia
      • Garran, Australia, 2605
        • Not yet recruiting
        • The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC)
    • 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
    • Queensland
      • Buderim, Queensland, Australia, 4556
        • Recruiting
        • University of the Sunshine Coast
      • Toowoomba, Queensland, Australia, 4350
        • Not yet recruiting
        • Toowoomba Hospital Oncology Clinical Trials
    • 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
        • Recruiting
        • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
      • Vienna, State of Salzburg, Austria, 1090
        • Recruiting
        • Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
  • Belgium
      • Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital | Oncology Department
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven Gasthuisberg - Pneumology Department
    • West-Flanders
      • Roeselare, West-Flanders, Belgium, 8800
        • Recruiting
        • AZ Delta | Clinical Trial Center - Pneumology
  • Brazil
    • 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
      • São Paulo, São Paulo, Brazil, 01308-050
        • Recruiting
        • Hospital Sírio Libanês
      • São Paulo, São Paulo, Brazil, 01323-030
        • Recruiting
        • A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
      • São Paulo, São Paulo, Brazil, 71635-610
        • Recruiting
        • Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
      • São Paulo, São Paulo, Brazil, 90020-090
        • Recruiting
        • Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
  • Bulgaria
    • Pazardzhik Province
      • Panagyurishte, Pazardzhik Province, Bulgaria, 4500
        • Recruiting
        • MHAT Uni Hospital
    • Pleven Province
      • Pleven, Pleven Province, Bulgaria, 5804
        • Recruiting
        • MHAT "Heart and brain" Pleven
    • Plovdiv Province
      • Plovdiv, Plovdiv Province, Bulgaria, 4004
        • Recruiting
        • Complex Oncology Center - Plovdiv EOOD
      • Plovdiv, Plovdiv Province, Bulgaria, 4109
        • Withdrawn
        • MHAT Park Hospital EOOD
    • Sofia City Province
      • Sofia, Sofia City Province, Bulgaria, 1404
        • Recruiting
        • Multiprofile Hospital for Active Treatment "Sveta Sofia"
      • Sofia, Sofia City Province, Bulgaria, 1632
        • Recruiting
        • MHAT Serdika
      • Sofia, Sofia City Province, Bulgaria, 1797
        • Recruiting
        • University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
      • Sofia, Sofia City Province, Bulgaria, 1797
        • Withdrawn
        • Specialized Hospital for Active Treatment of Oncology
    • Varna Province
      • Varna, Varna Province, Bulgaria, 9010
        • Recruiting
        • MHAT Sveta Marina EAD
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • 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, China, 101149
        • Recruiting
        • Beijing Chest Hospital, Capital Medical University
      • Beijing, China, 100000
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • Beijing, China, 100853
        • Recruiting
        • The People's Liberation Army General Hospital (Beijing 301 Hospital)
      • Chengdu, China, 610041
        • Recruiting
        • University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
      • Guangzhou, China, 510230
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
      • Jinan, China, 250117
        • Recruiting
        • Shandong University - Shandong Cancer Hospital
      • Linyi, China, 276001
        • Recruiting
        • LinYi Cancer Hospital (Linyi Tumor Hospital)
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
      • Nanning, China, 530021
        • Recruiting
        • Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
      • Xiamen, China, 361003
        • Recruiting
        • Xiamen University - The First Affiliated Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital - Oncology Department
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Withdrawn
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430023
        • Recruiting
        • Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital - Oncology Department
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
      • Nový Jicín, Czechia, 741 01
        • Recruiting
        • Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologie
      • Olomouc, Czechia, 77900
        • Withdrawn
        • Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
      • Ostrava - Vítkovice, Czechia, 703 00
        • Recruiting
        • Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddelení
    • Zlín
      • Zlín, Zlín, Czechia, 762 75
        • Recruiting
        • Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet - Kræftbehandling
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital
      • Herning, Central Jutland, Denmark, 7400
        • Withdrawn
        • Regionshospitalet Gødstrup - Medicinsk afdeling
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg University hospital - oncology department
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense University Hospital - Oncology Department
  • Finland
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • 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
        • Recruiting
        • Centre Hospitalier Michallon Grenoble - Service pneumologie
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
        • Recruiting
        • hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Recruiting
        • Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
    • Grand Est
      • Mulhouse, Grand Est, France, 68100
        • Recruiting
        • hopital Emile Muller - Service Pneumologie
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
        • Recruiting
        • Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonie - Unicancer Nouvelle Aquitaine
      • Limoges, New Aquitaine, France, 87000
        • 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
        • Recruiting
        • CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Recruiting
        • Hopital Nord Laennec - Oncologie medicale thoracique et digestive
      • Saint-Herblain, Pays de la Loire Region, France, 44800
        • Recruiting
        • Institut de Cancerologie Ouest - Saint-Herblain
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06100
        • Recruiting
        • Centre Antoine Lacassagne - Departement Oncologie
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94010
        • Recruiting
        • Centre Hospitalier Intercommunal Creteil - Service de pneumologie
      • Paris, Île-de-France Region, France, 75248
        • Recruiting
        • Institut Curie - Paris - Oncologie medicale
      • Paris, Île-de-France Region, France, 75014
        • Withdrawn
        • hopital cochin APHP - service de pneumologie
      • Suresnes, Île-de-France Region, France, 92150
        • Recruiting
        • Hopital Foch - Oncologie digestive et thoracique
      • Villejuif, Île-de-France Region, France, 94800
        • Recruiting
        • Gustave Roussy - Departement Oncologie-Radiotherapie
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
      • Hemer, Germany, 58675
        • Recruiting
        • Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
      • Nuremberg, Germany, 90419
        • Recruiting
        • Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
      • Stuttgart, Germany, 70376
        • Recruiting
        • Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • Recruiting
        • Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51109
        • Recruiting
        • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Recruiting
        • Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
      • Athens, Greece, 11527
        • Recruiting
        • Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
      • Athens, Greece, 12462
        • Recruiting
        • University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
      • Athens, Greece, 11526
        • Recruiting
        • ?enry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
      • Larissa, Greece, 41110
        • Recruiting
        • General University Hospital Of Larissa-Department of Medical Oncology
      • Piraeus, Greece, 18547
        • Withdrawn
        • Metropolitan Hospital- 4th Oncology Clinic
      • Thessaloniki, Greece, 57010
        • Recruiting
        • Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
    • Attica
      • Chaïdári, Attica, Greece, 12462
        • Recruiting
        • University General Hospital Attikon-4th Department of Internal Medicine
    • Thessaloniki
      • Pylaia Thessaloniki, Thessaloniki, Greece, 555 35
        • Recruiting
        • Genesis Hospital- Department of Pathological Oncology
  • Hong Kong
      • Kowloon, Hong Kong, 00000
        • 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
        • Recruiting
        • Queen Mary Hospital
  • Hungary
      • Budapest, Hungary, 1145
        • Recruiting
        • Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály
      • Tatabánya, Hungary, 2800
        • Withdrawn
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Public Hospital (R.A)
      • Beersheba, Israel, 8410101
        • 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
  • Italy
      • Florence, Italy, 50134
        • Not yet recruiting
        • Careggi University Hospital - Oncologia Clinica
      • Florence, Italy, 50134
        • Recruiting
        • Careggi University Hospital - Oncologia Clinica
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi Lecce - Oncologia
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele s.r.l. - Oncologia Medica
      • Palermo, Italy, 90146
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
      • Varese, Italy, 21100
        • Withdrawn
        • ASST Sette Laghi_Ospedale Macchi - Oncologia
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
    • Campania
      • Avellino, Campania, Italy, 83100
        • Recruiting
        • AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
      • Meldola, Emilia-Romagna, Italy, 47014
        • 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
        • Recruiting
        • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
      • Rome, Lazio, Italy, 00144
        • Recruiting
        • I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Recruiting
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto_Padova - UOC Oncologia 2
  • Japan
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Recruiting
        • National Hospital Organization Nagoya Medical Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
    • Hyōgo
      • Himeji, Hyōgo, Japan, 670-8520
        • Recruiting
        • National Hospital Organization Himeji Medical Center
      • Kobe, Hyōgo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Recruiting
        • Sendai Kousei Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Cancer Center
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School - Nippon Medical School Hospital - Cancer Center
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Recruiting
        • Tottori University Hospital
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • Recruiting
        • National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • 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
        • Recruiting
        • Gleneagles Penang Medical Center
      • Perai, Pulau Pinang, Malaysia, 13700
        • Recruiting
        • Sunway Medical Centre Penang
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 46050
        • Recruiting
        • Beacon Hospital
      • Shah Alam, Selangor, Malaysia, 40460
        • Recruiting
        • Columbia Asia Hospital Bukit Rimau
      • Subang Jaya, Selangor, Malaysia, 47500
        • Recruiting
        • Sunway Medical Centre
  • Mexico
      • Mexico City, Mexico, 3810
        • Recruiting
        • ONCARE Viaducto Napoles
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
      • Naucalpan, Mexico, 53100
        • Recruiting
        • Oncologia Integral Satelite
      • Puebla City, Mexico, 72530
        • 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
        • Recruiting
        • Nederlands Kanker Instituut
  • Poland
      • Bialystok, Poland, 15-276
        • Withdrawn
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Kielce, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii
      • Lodz, Poland, 92-213
        • Completed
        • Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi
      • Otwock, Poland, 05-400
        • Completed
        • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
      • Poznan, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
      • Warsaw, Poland, 01-138
        • Withdrawn
        • Instytut Gruzlicy i Chorob Pluc
      • Wroclaw, Poland, 53-413
        • Withdrawn
        • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Not yet recruiting
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Withdrawn
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Urologia
      • 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, 22328
        • Recruiting
        • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II
      • Bucharest, Romania, 30171
        • Recruiting
        • Spitalul Clinic Coltea
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • CardioMed S.R.L.
      • Craiova, Romania, 200745
        • Recruiting
        • Centrul de Oncologie Sfantul Nectarie
      • Ovidiu, Romania, 905900
        • Recruiting
        • S.C Ovidius Clinical Hospital SRL - Oncology Department
      • Timișoara, Romania, 300166
        • Recruiting
        • Oncocenter
    • Comuna Floresti
      • Flore?ti, Comuna Floresti, Romania, 407280
        • Recruiting
        • Radiotherapy Center Cluj SRL
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • Recruiting
        • Sc Oncolab Srl
  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 188770
        • Recruiting
        • Raffles Cancer Centre
      • Singapore, Singapore, 258499
        • Recruiting
        • OncoCare Cancer Centre | Gleneagles Medical Centre
      • Singapore, Singapore, 329563
        • Recruiting
        • Curie Oncology | Farrer
      • Singapore, Singapore, 168583
        • Not yet recruiting
        • National Cancer Center Singapore - Oncology Department
  • Slovakia
      • Poprad, Slovakia, 058 01
        • Recruiting
        • POKO Poprad s.r.o.
      • Trnava, Slovakia, 91775
        • Recruiting
        • Fakultna nemocnica Trnava
  • South Korea
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center - Oncology Department
      • Suwon, South Korea, 16247
        • Not yet recruiting
        • St.Vincent's Hospital - Oncology Department
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, South Korea, 52727
        • Recruiting
        • Gyeongsang National University Hospital
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
    • Jeollanam-do
      • Hwasun Gun, Jeollanam-do, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System - Oncology Department
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complexo Hospitalario Universitario A Coruna | Oncologia
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron | Oncologia
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona | Oncologia
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Maranon | Oncologia
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal | Oncologia
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz | Oncologia
      • Valencia, Spain, 46009
        • Recruiting
        • Fundacion Instituto Valenciano De Oncologia | Oncologia
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario Y Politecnico La Fe | Oncologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias I Pujol | Oncologia
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario De Navarra | Oncologia
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 221 85
        • Recruiting
        • Skånes Universitetssjukhus - Lund - STROKE UNIT?
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 901 85
        • Recruiting
        • Norrlands Universitetssjukhus Umeå - Cancercentrum
  • Switzerland
      • Fribourg, Switzerland, 1708
        • 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
        • Recruiting
        • 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
        • Recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Tip Fakultesi Hastanesi
      • Sakarya, Turkey (Türkiye), 54100
        • Recruiting
        • Sakarya Universitesi Egitim ve Arastirma Hastanesi
    • Adana
      • Yüreğir, Adana, Turkey (Türkiye), 1370
        • Recruiting
        • Adana Sehir Egitim ve Arastirma Hastanesi
    • Ankara
      • Bilkent Ankara, Ankara, Turkey (Türkiye), 6800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi
      • Yenimahalle, Ankara, Turkey (Türkiye), 6170
        • Recruiting
        • Ankara Etlik Şehir Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi
      • Küçükçekmece, Istanbul, Turkey (Türkiye), 34295
        • Recruiting
        • İ.A.Ü. VM Medical Park Florya Hastanesi
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Recruiting
        • LLC "RDP Ukraine" - Medical Department
      • Kropyvnytskyi, Ukraine, 25006
        • Recruiting
        • Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
      • Kyiv, Ukraine, 03189
        • Recruiting
        • Limited Liability Company "MedOffice Group Medical Center"
      • Kyiv, Ukraine, 03115
        • Recruiting
        • Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
      • Kyiv, Ukraine, 3039
        • Recruiting
        • Medical Center LLC "Verum Expert Clinic"
      • Lutsk, Ukraine, 43018
        • 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
        • Recruiting
        • MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 7AB
        • Withdrawn
        • Belfast City Hospital
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre University NHS Trust | 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
        • Recruiting
        • 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
        • Recruiting
        • Memorial Cancer Institute at Miramar
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute Orlando
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33612
        • 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, 60637
        • Recruiting
        • The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital - Outpatient Cancer Care Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • UM Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655-0002
        • Withdrawn
        • UMass Memorial Medical Center - University Campus - Hematology/Oncology
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Profound Research -OMG - TriAtria Cancer Center
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Profound Research - OMG - Royal Oak Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • 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
        • Recruiting
        • Providence Cancer Institute - Franz Clinic
      • Portland, Oregon, United States, 97225
        • Recruiting
        • 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
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Withdrawn
        • VCU Health Ambulatory Care Center - Cardiology

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

No

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
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

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)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 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)?

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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