AzTrials
AzTrials

Advanced Non-small Cell Lung Cancer, HER2 MutationPhase 3SOHO-02NCT06452277

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)

A Phase 3 study testing Sevabertinib, Pembrolizumab and Cisplatin in people with Advanced Non-small Cell Lung Cancer, HER2 Mutation, run by Bayer at 279 sites in 36 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sevabertinib, Pembrolizumab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
279 sitesin 36 countries
Study dates
28 Aug 2024to 27 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

279 sites in 36 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

18888422937

clinical-trials-contact@bayer.com

279 sites in 36 countries

United States25 sites, 14 recruiting

  • Piedmont Healthcare - Atlanta

    Atlanta, Georgia, 30318

    Recruiting

  • UM Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Not yet recruiting

  • University of Illinois Hospital - Outpatient Cancer Care Center

    Chicago, Illinois, 60612

    Recruiting

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

    Chicago, Illinois, 60637

    Withdrawn

  • UC Medical Center - Oncology

    Cincinnati, Ohio, 45219

    Recruiting

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

    Recruiting

  • University Hospital Simmons Cancer Center Lung/Head Neck Clinic

    Dallas, Texas, 75235

    Withdrawn

  • Profound Research -OMG - TriAtria Cancer Center

    Farmington Hills, Michigan, 48334

    Withdrawn

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

    Fort Lauderdale, Florida, 33316

    Recruiting

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

    Houston, Texas, 77030

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Recruiting

  • M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

    Withdrawn

  • Memorial Cancer Institute at Miramar

    Miramar, Florida, 33029

    Completed

  • R.J. Zuckerberg Cancer Center

    New Hyde Park, New York, 11042

    Withdrawn

  • Patty & George Hoag Cancer Center

    Newport Beach, California, 92663

    Withdrawn

  • AdventHealth Cancer Institute Orlando

    Orlando, Florida, 32804

    Not yet recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Providence Cancer Institute - Franz Clinic

    Portland, Oregon, 97213

    Not yet recruiting

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225

    Not yet recruiting

  • Profound Research - OMG - Royal Oak Cancer Center

    Royal Oak, Michigan, 48073

    Withdrawn

  • UC San Diego Health - Moores Cancer Center

    San Diego, California, 92037

    Withdrawn

  • UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology

    San Francisco, California, 94158

    Recruiting

  • UCLA Health Santa Monica Cancer Care

    Santa Monica, California, 90404

    Recruiting

  • Moffitt Cancer Center - Magnolia Campus

    Tampa, Florida, 33612

    Withdrawn

  • UMass Memorial Medical Center - University Campus - Hematology/Oncology

    Worcester, Massachusetts, 01655

    Withdrawn

Other trials in United States

China25 sites, 2 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Not yet recruiting

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • The People's Liberation Army General Hospital (Beijing 301 Hospital)

    Beijing, Beijing Municipality, 100853

    Not yet recruiting

  • Beijing chest hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Active, not recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Active, not recruiting

  • Hunan Cancer Hospital - Oncology Department

    Changsha, Hunan, 410013

    Active, not recruiting

  • University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Active, not recruiting

  • The first Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510160

    Active, not recruiting

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    Hangzhou, Zhejiang, 310016

    Active, not recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Active, not recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Withdrawn

  • Shandong University - Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Active, not recruiting

  • LinYi Cancer Hospital (Linyi Tumor Hospital)

    Linyi, Shandong, 276001

    Active, not recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Active, not recruiting

  • Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Active, not recruiting

  • Guangxi Medical University (GXMU) - Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

    Active, not recruiting

  • Shanghai Chest Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200030

    Active, not recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Active, not recruiting

  • Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province

    Taizhou, Jiangsu, 317000

    Active, not recruiting

  • Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech

    Wuhan, Hubei, 430023

    Active, not recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Active, not recruiting

  • Xiamen University - The First Affiliated Hospital

    Xiamen, Fujian, 361003

    Completed

Other trials in China

France17 sites

  • Institut Bergonie - Unicancer Nouvelle Aquitaine

    Bordeaux, New Aquitaine, 33076

    Active, not recruiting

  • Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie

    Brest, Brittany Region, 29200

    Active, not recruiting

  • Centre Hospitalier Intercommunal Creteil - Service de pneumologie

    Créteil, Île-de-France Region, 94010

    Active, not recruiting

  • Centre Hospitalier Michallon Grenoble - Service pneumologie

    La Tronche, Auvergne-Rhône-Alpes, 38700

    Active, not recruiting

  • Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire

    Lille, Hauts-de-France, 59000

    Active, not recruiting

  • Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique

    Limoges, New Aquitaine, 87000

    Active, not recruiting

  • CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique

    Montpellier, Occitanie, 34091

    Active, not recruiting

  • hopital Emile Muller - Service Pneumologie

    Mulhouse, Grand Est, 68100

    Withdrawn

  • Hopital Nord Laennec - Oncologie medicale thoracique et digestive

    Nantes, Pays de la Loire Region, 44093

    Active, not recruiting

  • Centre Antoine Lacassagne - Departement Oncologie

    Nice, Provence-Alpes-Côte d'Azur Region, 06100

    Active, not recruiting

  • APHP - Hopital Cochin - Service de Pneumologie

    Paris, Île-de-France Region, 75014

    Withdrawn

  • Institut Curie - Paris - Oncologie medicale

    Paris, Île-de-France Region, 75248

    Active, not recruiting

  • hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

    Active, not recruiting

  • CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie

    Rouen, Normandy, 76031

    Withdrawn

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, Pays de la Loire Region, 44800

    Active, not recruiting

  • Hopital Foch - Oncologie digestive et thoracique

    Suresnes, Île-de-France Region, 92150

    Withdrawn

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94800

    Active, not recruiting

Other trials in France

Italy17 sites

  • AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica

    Avellino, Campania, 83100

    Completed

  • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

    Aviano, Friuli Venezia Giulia, 33081

    Active, not recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica

    Bologna, Emilia-Romagna, 40138

    Active, not recruiting

  • Careggi University Hospital - Oncologia Clinica

    Florence, Tuscany, 50134

    Active, not recruiting

  • Ospedale Vito Fazzi Lecce - Oncologia

    Lecce, Apulia, 73100

    Withdrawn

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica

    Meldola, Emilia-Romagna, 47014

    Active, not recruiting

  • Ospedale San Raffaele s.r.l. - Oncologia Medica

    Milan, Lombardy, 20132

    Completed

  • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

    Milan, Lombardy, 20133

    Active, not recruiting

  • Istituto Europeo di Oncologia s.r.l - Oncologia Toracica

    Milan, Lombardy, 20141

    Active, not recruiting

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

    Orbassano, Piedmont, 10043

    Active, not recruiting

  • Istituto Oncologico Veneto_Padova - UOC Oncologia 2

    Padova, Veneto, 35128

    Active, not recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica

    Palermo, Sicily, 90146

    Active, not recruiting

  • I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2

    Rome, Lazio, 00144

    Active, not recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare

    Rome, Lazio, 00168

    Active, not recruiting

  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

    Rozzano, Lombardy, 20089

    Active, not recruiting

  • ASST Sette Laghi_Ospedale Macchi - Oncologia

    Varese, Lombardy, 21100

    Withdrawn

  • Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia

    Verona, Veneto, 37134

    Withdrawn

Other trials in Italy

Japan16 sites, 4 recruiting

  • Nippon Medical School - Nippon Medical School Hospital - Cancer Center

    Bunkyo-ku, Tokyo, 113-8603

    Not yet recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

    Active, not recruiting

  • National Hospital Organization Himeji Medical Center

    Himeji, Hyōgo, 670-8520

    Not yet recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Active, not recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Active, not recruiting

  • Saitama Cancer Center

    Kitaadachi, Saitama, 362-0806

    Active, not recruiting

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

    Active, not recruiting

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

    Active, not recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Active, not recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Active, not recruiting

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

    Active, not recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Not yet recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

    Active, not recruiting

  • National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)

    Ube, Yamaguchi, 755-0241

    Active, not recruiting

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

    Active, not recruiting

Other trials in Japan

Brazil12 sites, 10 recruiting

  • NAIC - Instituto do Cancer

    Bauru, São Paulo, 17033-490

    Recruiting

  • Centro de Pesquisa da Clínica de Oncologia Reichow

    Blumenau, Santa Catarina, 89010-340

    Recruiting

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

    Brasília, Federal District, 04538-132

    Recruiting

  • Pronutrir Fortaleza - CE

    Fortaleza, Ceará, 60810-180

    Recruiting

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Jaú, São Paulo, 14784-400

    Recruiting

  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

    Natal, Rio Grande do Norte, 59040-000

    Recruiting

  • Rede DoR Recife - PE

    Recife, Pernambuco, 50070-480

    Recruiting

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

    São José do Rio Preto, São Paulo, 15090-000

    Withdrawn

  • Hospital Sirio Libanes

    São Paulo, 01308-050

    Recruiting

  • A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante

    São Paulo, 01323-030

    Recruiting

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

    São Paulo, 71635-610

    Withdrawn

  • Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology

    São Paulo, 90020-090

    Recruiting

Other trials in Brazil

Spain12 sites

  • Complexo Hospitalario Universitario A Coruna | Oncologia

    A Coruña, 15006

    Withdrawn

  • Hospital Germans Trias I Pujol | Oncologia

    Badalona, Barcelona, 08916

    Active, not recruiting

  • Hospital Universitari Dexeus Grupo Quironsalud | Oncologia

    Barcelona, 08028

    Active, not recruiting

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035

    Active, not recruiting

  • Hospital Clinic De Barcelona | Oncologia

    Barcelona, 08036

    Withdrawn

  • Hospital General Universitario Gregorio Maranon | Oncologia

    Madrid, 28009

    Withdrawn

  • Hospital Universitario Ramon Y Cajal | Oncologia

    Madrid, 28034

    Withdrawn

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia

    Madrid, 28040

    Withdrawn

  • Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia

    Majadahonda, Madrid, 28222

    Active, not recruiting

  • Hospital Universitario De Navarra | Oncologia

    Pamplona, Navarre, 31008

    Active, not recruiting

  • Fundacion Instituto Valenciano De Oncologia | Oncologia

    Valencia, 46009

    Withdrawn

  • Hospital Universitario Y Politecnico La Fe | Oncologia

    Valencia, 46026

    Active, not recruiting

Other trials in Spain

Bulgaria9 sites, 6 recruiting

  • MHAT Uni Hospital

    Panagyurishte, Pazardzhik Province, 4500

    Not yet recruiting

  • MHAT "Heart and brain" Pleven

    Pleven, Pleven Province, 5804

    Not yet recruiting

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, Plovdiv Province, 4004

    Not yet recruiting

  • MHAT Park Hospital EOOD

    Plovdiv, Plovdiv Province, 4109

    Withdrawn

  • MHAT Serdikamed

    Sofia, Sofia City Province, 1303

    Active, not recruiting

  • Multiprofile Hospital for Active Treatment "Sveta Sofia"

    Sofia, Sofia City Province, 1404

    Recruiting

  • Specialized Hospital for Active Treatment of Oncology

    Sofia, Sofia City Province, 1797

    Withdrawn

  • University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia

    Sofia, Sofia City Province, 1797

    Not yet recruiting

  • MHAT Sveta Marina EAD

    Varna, Varna Province, 9010

    Not yet recruiting

Other trials in Bulgaria

Greece9 sites

  • Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit

    Athens, 11526

    Active, not recruiting

  • Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine

    Athens, 11527

    Active, not recruiting

  • General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA

    Athens, 11528

    Active, not recruiting

  • University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine

    Athens, 12462

    Active, not recruiting

  • University General Hospital Attikon-4th Department of Internal Medicine

    Chaïdári, Attica, 12462

    Withdrawn

  • University General Hospital Of Larissa | Medical Oncology

    Larissa, 41110

    Withdrawn

  • Metropolitan Hospital- 4th Oncology Clinic

    Piraeus, 18547

    Withdrawn

  • Genesis Hospital- Department of Pathological Oncology

    Pylaia Thessaloniki, 555 35

    Withdrawn

  • Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department

    Thessaloniki, 57010

    Active, not recruiting

Other trials in Greece

Romania9 sites

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II

    Bucharest, Bucharest Municipality, 22328

    Active, not recruiting

  • Spitalul Clinic Coltea

    Bucharest, Bucharest Municipality, 30171

    Withdrawn

  • CardioMed S.R.L.

    Cluj-Napoca, Cluj, 400015

    Withdrawn

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015

    Active, not recruiting

  • Sc Oncolab Srl

    Craiova, Dolj, 200385

    Withdrawn

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, Dolj, 200745

    Active, not recruiting

  • Radiotherapy Center Cluj SRL

    Florești, Comuna Floresti, 407280

    Active, not recruiting

  • S.C Ovidius Clinical Hospital SRL - Oncology Department

    Ovidiu, Constanța County, 905900

    Withdrawn

  • Oncocenter

    Timișoara, Timiș County, 300166

    Withdrawn

Other trials in Romania

Germany8 sites, 3 recruiting

  • Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie

    Berlin, 12203

    Not yet recruiting

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

    Cologne, North Rhine-Westphalia, 51109

    Active, not recruiting

  • Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)

    Essen, North Rhine-Westphalia, 45147

    Active, not recruiting

  • Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie

    Frankfurt am Main, Hesse, 60590

    Not yet recruiting

  • Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie

    Giessen, Hesse, 35392

    Not yet recruiting

  • Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin

    Hemer, North Rhine-Westphalia, 58675

    Active, not recruiting

  • Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)

    Nuremberg, Bavaria, 90419

    Active, not recruiting

  • Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin

    Stuttgart, Baden-Wurttemberg, 70376

    Completed

Other trials in Germany

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

    Withdrawn

  • Swietokrzyskie Centrum Onkologii

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Completed

  • Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi

    Lodz, Łódź Voivodeship, 92-213

    Completed

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku

    Otwock, Masovian Voivodeship, 05-400

    Withdrawn

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii

    Poznan, Greater Poland Voivodeship, 60-569

    Active, not recruiting

  • Instytut Gruzlicy i Chorob Pluc

    Warsaw, Masovian Voivodeship, 01-138

    Withdrawn

  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej

    Warsaw, Masovian Voivodeship, 02-781

    Withdrawn

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, Lower Silesian Voivodeship, 53-413

    Withdrawn

Other trials in Poland

South Korea8 sites, 8 recruiting

  • Chungbuk National University Hospital | Hematology and Oncology

    Chungcheongbuk-do, North Chungcheong, 28644

    Not yet recruiting

  • Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine

    Hwasun-gun, Jeollanam-do, 58128

    Not yet recruiting

  • Gyeongsang National University Hospital | Oncology

    Jinju, Gyeongsangnam-do, 52727

    Not yet recruiting

  • Seoul National University Hospital | Oncology

    Jongno -Gu, Seoul, 03080

    Recruiting

  • Severance Hospital | Oncology

    Seoul, 03722

    Recruiting

  • Samsung Medical Center | Oncology

    Seoul, 06351

    Recruiting

  • St Vincent's Hospital | Oncology

    Suwon, Gyeonggi-do, 16247

    Not yet recruiting

  • Pusan National University Yangsan Hospital | Pulmonology

    Yangsan, Gyeongsangnam-do, 50612

    Recruiting

Other trials in South Korea

Taiwan8 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

    Completed

  • Chung Shan Medical University Hospital

    Taichung, 402306

    Active, not recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Active, not recruiting

  • Chi-Mei Medical Center, Liouyine

    Tainan, 73657

    Completed

  • National Taiwan University Hospital (NTUH) - Cancer Research Center

    Taipei, 100225

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Active, not recruiting

Other trials in Taiwan

Turkey (Türkiye)8 sites, 3 recruiting

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, Aksaray, 6800

    Active, not recruiting

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

    Completed

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

    Active, not recruiting

  • İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi

    Kadıköy, Istanbul, 34722

    Active, not recruiting

  • İ.A.Ü. VM Medical Park Florya Hastanesi

    Küçükçekmece, Istanbul, 34295

    Not yet recruiting

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi

    Sakarya, 54100

    Not yet recruiting

  • Ankara Etlik Sehir Hastanesi

    Yenimahalle, Ankara, 6170

    Not yet recruiting

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Yüreğir, Adana, 1370

    Completed

Other trials in Turkey (Türkiye)

Ukraine8 sites, 6 recruiting

  • LLC "RDP Ukraine" - Medical Department

    Dnipro, Dnipropetrovsk Oblast, 49102

    Not yet recruiting

  • Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center

    Kropyvnytskyi, Kirovohrad Oblast, 25006

    Not yet recruiting

  • Kyiv City Clinical Oncology Center - Department of Chemotherapy #1

    Kyiv, Kyiv City, 03115

    Not yet recruiting

  • Limited Liability Company "MedOffice Group Medical Center"

    Kyiv, Kyiv City, 03189

    Active, not recruiting

  • Medical Center LLC "Verum Expert Clinic"

    Kyiv, Kyiv City, 3039

    Not yet recruiting

  • Regional Medical Oncology Centre_Oncology Chemotherapy Department

    Lutsk, Volyn Oblast, 43018

    Not yet recruiting

  • Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department

    Rivne, Rivne Oblast, 33010

    Active, not recruiting

  • MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department

    Uzhhorod, Zakarpattia Oblast, 88000

    Not yet recruiting

Other trials in Ukraine

Malaysia7 sites, 3 recruiting

  • University Hospital Kebangsaan Malaysia

    Cheras, Kuala Lumpur and Selangor, 56000

    Withdrawn

  • Gleneagles Penang Medical Center

    George Town, Pulau Pinang, 10050

    Not yet recruiting

  • Universiti Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

    Active, not recruiting

  • Sunway Medical Centre Penang

    Perai, Pulau Pinang, 13700

    Active, not recruiting

  • Beacon Hospital

    Petaling Jaya, Selangor, 46050

    Not yet recruiting

  • Columbia Asia Hospital Bukit Rimau

    Shah Alam, Selangor, 40460

    Not yet recruiting

  • Sunway Medical Centre

    Subang Jaya, Selangor, 47500

    Active, not recruiting

Other trials in Malaysia

Argentina6 sites

  • Fundación Cenit para la Investigación en Neurociencias

    Buenos Aires, C1125 ABD

    Withdrawn

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Withdrawn

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

    Buenos Aires, C1431FWO

    Withdrawn

  • Centro Médico Privado CEMAIC

    Córdoba, X5008HHW

    Withdrawn

  • Instituto Argentino de Diagnostico y Tratamiento (IADT)

    TBC, Buenos Aires, B1841

    Withdrawn

  • Centro de Investigaciones Clínicas, Clínica Viedma

    Viedma, Río Negro Province, R8500ACE

    Withdrawn

Other trials in Argentina

Australia6 sites

  • NSW Health - Blacktown Hospital

    Blacktown, New South Wales, 2148

    Active, not recruiting

  • University of the Sunshine Coast

    Buderim, Queensland, 4556

    Withdrawn

  • Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit

    Concord, New South Wales, 2139

    Completed

  • Austin Hospital - Olivia Newton John Cancer Research Institute

    Heidelberg, Victoria, 3084

    Active, not recruiting

  • Toowoomba Hospital Oncology Clinical Trials

    Toowoomba, Queensland, 4350

    Withdrawn

  • Calvary Mater Hospital Newcastle - Oncology

    Waratah, New South Wales, 2298

    Active, not recruiting

Other trials in Australia

Mexico6 sites, 1 recruiting

  • Instituto Nacional de Cancerología

    Mexico City, Mexico City, 14080

    Completed

  • Oncare Viaducto Nápoles

    Mexico City, Mexico City, 3810

    Active, not recruiting

  • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia

    Monterrey, Nuevo León, 64460

    Active, not recruiting

  • Oncología Integral Satélite

    Naucalpan, State of Mexico, 53100

    Active, not recruiting

  • Clinica Integral Internacional de Oncologia S. de R.L. de C.V.

    Puebla City, 72530

    Not yet recruiting

  • ONCARE Treatment Center

    San Pedro Garza García, Nuevo León, 66220

    Active, not recruiting

Other trials in Mexico

Czechia5 sites, 1 recruiting

  • Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)

    Brno, South Moravian, 602 00

    Recruiting

  • Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie

    Nový Jičín, Moravian-Silesian Region, 741 01

    Withdrawn

  • Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy

    Olomouc, Olomouc Region, 779 00

    Withdrawn

  • Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení

    Ostrava - Vítkovice, Moravian-Silesian Region, 703 00

    Withdrawn

  • Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie

    Zlín, Zlín, 762 75

    Withdrawn

Other trials in Czechia

Denmark5 sites

  • Aalborg Universitetshospital - Onkologisk afdeling

    Aalborg, North Denmark Region / Region Nordjylland, 9000

    Withdrawn

  • Aarhus Universitetshospital

    Aarhus N, Central Denmark Region / Region Midtjylland, 8200

    Completed

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    Copenhagen, Capital Region / Region Hovedstaden, 2100

    Active, not recruiting

  • Regionshospitalet Gødstrup - Medicinsk afdeling

    Herning, Central Denmark Region / Region Midtjylland, 7400

    Withdrawn

  • Odense University Hospital | Svendborg Sygehus - Oncology Department

    Odense, Region of Southern Denmark / Region Syddanmark, 5000

    Active, not recruiting

Other trials in Denmark

Portugal5 sites, 3 recruiting

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia

    Coimbra, Beira Litoral, 3004-561

    Completed

  • Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

    Lisbon, 1400-038

    Completed

  • CHULN - Hospital Pulido Valente

    Lisbon, 1769-001

    Recruiting

  • Hospital Pedro Hispano | Clinical Research Center

    Matosinhos Municipality, Porto District, 4464-513

    Recruiting

  • IPO Porto

    Porto, 4200-072

    Recruiting

Other trials in Portugal

Singapore5 sites

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583

    Active, not recruiting

  • Raffles Cancer Centre

    Singapore, 188770

    Completed

  • OncoCare Cancer Centre | Gleneagles Medical Centre

    Singapore, 258499

    Active, not recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433

    Completed

  • Curie Oncology | Farrer

    Singapore, 329563

    Completed

Other trials in Singapore

Austria4 sites

  • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III

    Vienna, State of Salzburg, 1090

    Withdrawn

  • Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde

    Vienna, State of Salzburg, 1090

    Withdrawn

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

    Vienna, State of Vienna, 1090

    Withdrawn

  • Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik

    Vienna, 1210

    Active, not recruiting

Other trials in Austria

Canada4 sites, 3 recruiting

  • Brampton Civic Hospital | Oncology

    Brampton, Ontario, L6R 3J7

    Recruiting

  • Jewish General Hospital | Pulmonary Oncology

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Princess Margaret Cancer Centre | Medical Oncology and Hematology

    Toronto, Ontario, M5G 2C4

    Recruiting

  • BC Cancer | Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Completed

Other trials in Canada

Hong Kong4 sites, 3 recruiting

  • Prince of Wales Hospital

    Hong Kong, Hong Kong SAR, 00000

    Recruiting

  • Queen Elizabeth Hospital Hong Kong

    Hong Kong, Hong Kong SAR, 00000

    Recruiting

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR, 00000

    Not yet recruiting

  • Hong Kong United Oncology Centre

    Kowloon, 00000

    Active, not recruiting

Other trials in Hong Kong

Israel4 sites

  • Assuta Ashdod Public Hospital (R.A)

    Ashdod, Central District, 7747629

    Active, not recruiting

  • Soroka Medical Center- Legacy Heritage Cancer Center

    Beersheba, Southern District, 8410101

    Completed

  • Shaare Zedek Medical Center (SZMC)

    Jerusalem, 91031

    Active, not recruiting

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6423906

    Completed

Other trials in Israel

United Kingdom4 sites

  • Belfast City Hospital | Oncology

    Belfast, Northern Ireland, BT12 7AB

    Withdrawn

  • Velindre Cancer Centre | Clinical Trials Unit

    Cardiff, Wales, CF14 2TL

    Withdrawn

  • Royal Surrey County Hospital | Cancer Centre

    Guildford, Surrey, GU2 7XX

    Active, not recruiting

  • Torbay Hospital | Oncology

    Torquay, Devon, TQ2 7AA

    Active, not recruiting

Other trials in United Kingdom

Belgium3 sites

  • Antwerp University Hospital | Oncology Department

    Antwerp, Antwerp, 2650

    Withdrawn

  • UZ Leuven Gasthuisberg - Pneumology Department

    Leuven, Flemish Brabant, 3000

    Active, not recruiting

  • AZ Delta | Clinical Trial Center - Pneumology

    Roeselare, West Flanders, 8800

    Active, not recruiting

Other trials in Belgium

Finland2 sites

  • Docrates Mehiläinen Syöpäsairaala

    Helsinki, Uusimaa, 00180

    Withdrawn

  • Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka

    Turku, Southwest Finland, 20520

    Withdrawn

Other trials in Finland

Hungary2 sites

  • Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály

    Budapest, 1145

    Withdrawn

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, Komárom-Esztergom, 2800

    Withdrawn

Other trials in Hungary

Netherlands2 sites

  • Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX

    Active, not recruiting

  • Radboud University Medical Center | Afdeling Interne Geneeskunde

    Nijmegen, Gelderland, 6500 HB

    Withdrawn

Other trials in Netherlands

Slovakia2 sites

  • POKO Poprad s.r.o.

    Poprad, Presov, 058 01

    Withdrawn

  • Fakultna nemocnica Trnava

    Trnava, 917 75

    Completed

Other trials in Slovakia

Sweden2 sites

  • Skånes Universitetssjukhus - Lund - Lungmedicin

    Lund, 221 85

    Active, not recruiting

  • Norrlands Universitetssjukhus Umeå - Cancercentrum

    Umeå, Västerbotten County, 901 85

    Completed

Other trials in Sweden

Switzerland2 sites, 1 recruiting

  • Kantonsspital Baden

    Baden, Canton of Aargau, 5404

    Active, not recruiting

  • HFR Freiburg - Kantonsspital

    Fribourg, 1708

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

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.

Read more

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.
Being tested
Sevabertinib, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed
Keywords
NSCLC, ERBB2 mutation, HER2 mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06452277
Study groupRoleWhat they receive
SevabertinibExperimentalParticipants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.
Receives: Drug: Sevabertinib
Standard of care (SoC)Active comparatorParticipants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.
Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) per RECIST 1.1 as assessed by BICR

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)

    Measured: Up to approximately 2 years

Secondary outcomes (16)

  1. Overall survival (OS)

    Measured: Up to approximately 4 years.

  2. Objective response rate (ORR) per RECIST 1.1 as assessed by BICR

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)

    Measured: Up to approximately 4 years

  3. Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: Up to approximately 4 years

  4. Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator

    Measured: Up to approximately 4 years

  5. Disease control rate (DCR) per RECIST 1.1 as assessed by BICR

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)

    Measured: Up to approximately 4 years

  6. Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: Up to approximately 4 years

  7. Duration of response (DOR) as assessed by BICR

    BICR = blinded independent central review (BICR)

    Measured: Up to approximately 4 years

  8. Duration of response (DOR) as assessed by the investigator

    Measured: Up to approximately 4 years

  9. Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity

    CTCAE = common terminology criteria for adverse events; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event

    Measured: Up to approximately 4 years

  10. Change from baseline in NSCLC-SAQ total score

    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire

    Measured: Up to approximately 4 years

  11. Change from baseline in NSCLC-SAQ individual domain scores

    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite

    Measured: Up to approximately 4 years

  12. Time to deterioration in NSCLC-SAQ total score

    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire

    Measured: Up to approximately 4 years

  13. Time to deterioration in NSCLC-SAQ individual domain scores

    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite

    Measured: Up to approximately 4 years

  14. Time to deterioration in EORTC QLQ-C30 physical functioning domain score

    EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

    Measured: Up to approximately 4 years

  15. Change from baseline in EORTC QLQ-C30 physical functioning domain score

    EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life

    Measured: Up to approximately 4 years

  16. Change from baseline in EORTC QLQ-C30 global health status/QoL

    EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start28 Aug 2024
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion27 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452277
Sponsor's protocol ID
22615
Other IDs
2024-511319-91-00
Acronym
SOHO-02
Status last verified
22 Sep 2026
First submitted
5 Jun 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevabertinib, Pembrolizumab and Cisplatin in people with Advanced Non-small Cell Lung Cancer, HER2 Mutation, run by Bayer at 279 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 279 sites in United States, China, France, Italy, Japan and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) per RECIST 1.1 as assessed by BICR (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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