account_circleRecruiting

Advanced non-small cell lung cancer, HER2 mutation

A study to learn more about how well Sevabertinib (BAY 2927088) 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)

Trial purpose

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, BAY 2927088, 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 BAY 2927088 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:
•   BAY 2927088 twice every day as a tablet by mouth, or
•   Standard treatment in cycles of 21 days via infusion (“drip”) into the vein.
The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the 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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
278
Trial Dates
August 2024 - April 2029
Phase
Phase 3
Could I Receive a placebo
No
Products
BAY2927088
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
hopital Emile Muller - Service PneumologieMulhouse, 68100, France
Recruiting
Centre Hospitalier Intercommunal Creteil - Service de pneumologieCréteil, 94010, France
Recruiting
Institut Bergonie - Unicancer Nouvelle AquitaineBordeaux, 33076, France
Recruiting
Institut Curie - Paris - Oncologie medicaleParis, 75248, France
Recruiting
Institut de Cancerologie Ouest - Saint-HerblainSaint-Herblain, 44800, France
Recruiting
Gustave Roussy - Departement Oncologie-RadiotherapieVillejuif, 94800, France
Withdrawn
Hospital de Base | Integrated Research CenterSão José do Rio Preto, 15090-000, Brazil
Recruiting
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - BrasiliaBrasilia, 71635-610, Brazil
Recruiting
Pronutrir Fortaleza - CEFortaleza, 60810-180, Brazil
Recruiting
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59040-000, Brazil
Recruiting
Hospital Sirio LibanesSao Paulo, 01308-050, Brazil
Recruiting
A Beneficencia Portuguesa de Sao Paulo - Hospital BP MiranteSao Paulo, 01323-030, Brazil
Recruiting
Fundacao Pio XII - Hospital de Cancer de BarretosBarretos, 14784-400, Brazil
Recruiting
Centro de Pesquisa da Clínica de Oncologia ReichowBlumenau, 89010-340, Brazil
Recruiting
Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria LimaSao Paulo, 04538-132, Brazil
Recruiting
Hopital Foch - Oncologie digestive et thoraciqueSuresnes, 92150, France
Recruiting
Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaireLille, 59000, France
Withdrawn
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)Buenos Aires, C1431FWO, Argentina
Withdrawn
Hospital Italiano de Buenos AiresBuenos Aires, C1199ABB, Argentina
Recruiting
Rede DoR Recife - PERecife, 50070-480, Brazil
Recruiting
NAIC - Instituto do CancerBauru, 17033-490, Brazil
Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre | OncologyPorto Alegre, 90020-090, Brazil
Recruiting
UZ Leuven Gasthuisberg - Pneumology DepartmentLeuven, 3000, Belgium
Recruiting
AZ Delta | Clinical Trial Center - PneumologyRoeselare, 8800, Belgium
Recruiting
Antwerp University Hospital | Oncology DepartmentAntwerpen, 2650, Belgium
Recruiting
IPO PortoPorto, 4200-072, Portugal
Recruiting
Kansai Medical University HospitalHirakata, 573-1191, Japan
Recruiting
National Hospital Organization Kyushu Medical CenterFukuoka, 810-8563, Japan
Recruiting
National Hospital Organization Himeji Medical CenterHimeji, 670-8520, Japan
Recruiting
Hokkaido University HospitalSapporo, 060-8648, Japan
Recruiting
Tottori University HospitalYonago, 683-8504, Japan
Recruiting
Saitama Cancer CenterKitaadachi-gun, 362-0806, Japan
Recruiting
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Recruiting
Osaka International Cancer InstituteOsaka, 541-8567, Japan
Recruiting
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Recruiting
Sendai Kousei HospitalSendai, 980-0873, Japan
Recruiting
Centre Hospitalier Universitaire de Limoges - unite oncologie thoraciqueLimoges, 87000, France
Recruiting
CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoraciqueMontpellier, 34091, France
Recruiting
Chungbuk National University HospitalCheongju-si, 28644, Korea,_republic_of
Recruiting
Severance Hospital, Yonsei University Health System - Oncology DepartmentSeoul, 03722, Korea,_republic_of
Recruiting
Chonnam National University Hwasun HospitalHwasun Gun, 58128, Korea,_republic_of
Recruiting
Samsung Medical Center - Oncology DepartmentSeoul, 06351, Korea,_republic_of
Recruiting
Gyeongsang National University HospitalJinju-si, 52727, Korea,_republic_of
Recruiting
Pusan National University Yangsan HospitalYangsan-si, 50612, Korea,_republic_of
Recruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th StreetFort Lauderdale, 33316, United States
Withdrawn
Patty & George Hoag Cancer CenterNewport Beach, 92663, United States
Recruiting
Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and HematologyToronto, M5G 2C4, Canada
Recruiting
Nederlands Kanker InstituutAMSTERDAM, 1066 CX, Netherlands
Recruiting
Kindai University HospitalOsakasayama, 589-8511, Japan
Withdrawn
Radboud University Medical Center | Afdeling Interne GeneeskundeNijmegen, 6500 HB, Netherlands
Recruiting
Curie Oncology | FarrerSingapore, 329563, Singapore
Recruiting
Kobe University HospitalKobe, 650-0017, Japan
Recruiting
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Withdrawn
Fundación Cenit para la Investigación en NeurocienciasCABA, C1125 ABD, Argentina
Recruiting
Centro Ricerche Cliniche Di Verona S.r.l. - OncologiaVerona, 37134, Italy
Recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia MedicaOrbassano, 10043, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-PolmonareRoma, 00168, Italy
Recruiting
Istituto Europeo di Oncologia s.r.l - Oncologia ToracicaMilano, 20141, Italy
Recruiting
Humanitas Mirasole S.p.A. - Oncologia Medica ed EmatologiaRozzano, 20089, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1Milano, 20133, Italy
Recruiting
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2Roma, 00128, Italy
Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP ToracicaMeldola, 47014, Italy
Recruiting
AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia MedicaAvellino, 83100, Italy
Recruiting
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-CorrelatiAviano, 33081, Italy
Recruiting
Shaare Zedek Medical Center (SZMC)Jerusalem, 91031, Israel
Recruiting
National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)Ube, 755-0241, Japan
Recruiting
Jewish General Hospital - Department of Pulmonary OncologyMontreal, H3T 1E2, Canada
Recruiting
CHULN - Hospital Pulido ValenteLisboa, 1769-001, Portugal
Recruiting
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao ClinicaLisboa, 1400-038, Portugal
Recruiting
Hospital Pedro Hispano | Clinical Research CenterMatosinhos, 4464-513, Portugal
Not yet recruiting
BC Cancer - Vancouver SiteVancouver, V5Z 4E6, Canada
Withdrawn
Instituto Argentino de Diagnostico y Tratamiento (IADT)TBC, TBC, Argentina
Recruiting
Soroka Medical Center- Legacy Heritage Cancer CenterBe'er Sheva, 8410101, Israel
Not yet recruiting
The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC)Garran, 2605, Australia
Recruiting
Calvary Mater Hospital NewcastleWaratah, 2298, Australia
Recruiting
OncoCare Cancer Centre | Gleneagles Medical CentreSingapore, 258499, Singapore
Not yet recruiting
Belfast City HospitalBelfast, BT12 7AB, United Kingdom
Recruiting
hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoraciquePierre Bénite, 69310, France
Recruiting
Centre Hospitalier Michallon Grenoble - Service pneumologieLa Tronche, 38700, France
Recruiting
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Recruiting
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)Barcelona, 08036, Spain
Recruiting
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) LocationBadalona, 8916, Spain
Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia MedicaBologna, 40138, Italy
Recruiting
Hospital Quiron Dexeus - OncologiaBarcelona, 08028, Spain
Recruiting
Hospital Universitario De Navarra - OncologiaPamplona, 31008, Spain
Recruiting
Hospital Universitario Y Politecnico La Fe - OncologiaValencia, 46026, Spain
Recruiting
Complejo Hospitalario Universitario A Coruna (CHUAC)A Coruna, 15006, Spain
Recruiting
Fundacion Instituto Valenciano de Oncologia (IVOValencia, 46009, Spain
Recruiting
Niigata Cancer Center HospitalNiigata, 951-8566, Japan
Recruiting
Nippon Medical School - Nippon Medical School Hospital - Cancer CenterBunkyo-ku, 113-8603, Japan
Withdrawn
Regionshospitalet Gødstrup - Medicinsk afdelingHerning, 7400, Denmark
Recruiting
Rigshospitalet - KræftbehandlingCopenhagen OE, 2100, Denmark
Recruiting
Istituto Oncologico Veneto_Padova - UOC Oncologia 2Padova, 35128, Italy
Recruiting
Beijing Cancer Hospital - Oncology DepartmentBeijing, 100142, China
Recruiting
Beijing HospitalBeijing, 100730, China
Recruiting
Shandong University - Shandong Cancer HospitalJinan, 250117, China
Recruiting
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w OtwockuOtwock, 05-400, Poland
Recruiting
National Hospital Organization Nagoya Medical CenterNagoya, 460-0001, Japan
Recruiting
Kitasato University HospitalSagamihara, 252-0375, Japan
Recruiting
Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ LungenheilkundeSalzburg, 5020, Austria
Recruiting
UM Greenebaum Comprehensive Cancer CenterBaltimore, 21201, United States
Recruiting
Torbay HospitalTorquay, TQ2 7AA, United Kingdom
Withdrawn
Centro Médico Privado CEMAICCórdoba, X5008HHW, Argentina
Recruiting
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Withdrawn
CHU de Rouen - Hopital Charles Nicolle - Service de PneumologieRouen, 76031, France
Recruiting
Shanghai Chest Hospital, Shanghai Jiaotong UniversityShanghai, 200030, China
Recruiting
Kantonsspital BadenBaden, 5404, Switzerland
Recruiting
University General Hospital ATTIKON, Department of Internal Medicine IVChaidari, 12462, Greece
Recruiting
ONCARE Treatment CenterSan Pedro Garza García, 66220, Mexico
Recruiting
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imageriebrest, 29200, France
Recruiting
Hospital Universitario Fundacion Jimenez Diaz- Oncology ServiceMadrid, 28040, Spain
Recruiting
Hospital General Universitario Gregorio Maranon | OncologiaMadrid, 28009, Spain
Recruiting
Hospital Universitario Puerta De Hierro De Majadahonda - OncologiaMajadahonda, 28222, Spain
Recruiting
University General Hospital of Athens "ATTIKON"Chaidari, 12462, Greece
Recruiting
Bioclinic ThessalonikiThessaloniki, 54622, Greece
Recruiting
PAPANIKOLAOU General Hospital of ThessalonikiThessaloniki, 57010, Greece
Recruiting
University General Hospital of LarissaLarissa, 41110, Greece
Recruiting
General Hospital of Athens “Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUAAthens, 11528, Greece
Recruiting
University of Athens Medical School-Sotiria General Hospital - 3rd Dept of Medicine & Medical OncologyAthens, 11527, Greece
Recruiting
Raffles Cancer CentreSingapore, 188770, Singapore
Recruiting
Odense University Hospital - Oncology DepartmentOdense C, 5000, Denmark
Recruiting
Chi-Mei Medical Center, LiouyineTainan, 73657, Taiwan
Recruiting
Chung Shan Medical University HospitalTaichung, 402306, Taiwan
Recruiting
National Cheng Kung University HospitalTainan, 704, Taiwan
Recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Recruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Recruiting
Aalborg University hospital - oncology departmentAalborg, 9000, Denmark
Recruiting
Aarhus UniversitetshospitalAarhus N, 8200, Denmark
Recruiting
Klinik Floridsdorf, Pneumo-onkologische Ambulanz und TagesklinikWien, 1210, Austria
Recruiting
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für OnkologieWien, 1090, Austria
Recruiting
Profound Research - OMG - Royal Oak Cancer CenterRoyal Oak, 48073, United States
Recruiting
Profound Research -OMG - TriAtria Cancer CenterFarmington Hills, 48334, United States
Recruiting
Assuta Ashdod Public Hospital (R.A)Ashdod, 7747629, Israel
Not yet recruiting
Lungenklinik Hemer, Thorakale Onkologie und onkologische PalliativmedizinHemer, 58675, Germany
Recruiting
Robert Bosch Krankenhaus - Haematologie, Onkologie und PalliativmedizinStuttgart, 70376, Germany
Not yet recruiting
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - LungenklinikKöln, 51109, Germany
Not yet recruiting
Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV OrganonkologieGiessen, 35392, Germany
Recruiting
Providence Cancer Institute - Franz ClinicPortland, 97213, United States
Recruiting
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin IIISalzburg, 5020, Austria
Recruiting
Royal Surrey County HospitalGuildford, GU2 7XX, United Kingdom
Recruiting
The University of Chicago Medical Center - Hyde Park - Hematology & OncologyChicago, 60637, United States
Recruiting
hopital cochin APHP - service de pneumologieParis, 75014, France
Recruiting
Instituto Nacional de CancerologíaMexico, 14080, Mexico
Recruiting
Oncare Viaducto NápolesCDMX, 3810, Mexico
Recruiting
Oncología Integral SatéliteNaucalpan, 53100, Mexico
Recruiting
Skåne University HospitalLund, 221 85, Sweden
Recruiting
MHAT "Heart and brain" PlevenPleven, 5804, Bulgaria
Recruiting
MHAT SerdikaSofia, 1632, Bulgaria
Recruiting
University Multiprofile Hospital For Active Treatment Sofiamed OOD, SofiaSofia, 1797, Bulgaria
Recruiting
MHAT Uni HospitalPanagyurishte, 4500, Bulgaria
Not yet recruiting
Specialized Hospital for Active Treatment of OncologySofia, 1797, Bulgaria
Recruiting
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Recruiting
Multiprofile Hospital for Active Treatment "Sveta Sofia"Sofia, 1404, Bulgaria
Not yet recruiting
MHAT Park Hospital EOODPlovdiv, 4109, Bulgaria
Recruiting
Complex Oncology Center - Plovdiv EOODPlovdiv, 4004, Bulgaria
Not yet recruiting
Metropolitan Hospital- 4th Oncology ClinicPiraeus, 18547, Greece
Recruiting
Docrates Mehiläinen SyöpäsairaalaHelsinki, FIN-00180, Finland
Recruiting
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Recruiting
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w LodziLodz, 92-213, Poland
Recruiting
Swietokrzyskie Centrum OnkologiiKielce, 25-734, Poland
Recruiting
Wielkopolskie Centrum Pulmonologii i TorakochirurgiiPoznan, 60-569, Poland
Not yet recruiting
Dolnoslaskie Centrum Onkologii, Pulmonologii i HematologiiWroclaw, 53-413, Poland
Recruiting
Norrland University Hospital - CancercentrumUmeå, 90185, Sweden
Not yet recruiting
Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir HastanesiKadikoy, 34722, Turkey
Recruiting
Adana Sehir Egitim ve Arastirma HastanesiYuregir, 1370, Turkey
Not yet recruiting
Ankara Bilkent Sehir HastanesiBilkent ankara, 6800, Turkey
Recruiting
Ankara Etlik Sehir HastanesiYenimahalle, 6170, Turkey
Recruiting
I.A.Ü. VM Medical Park Florya HastanesiKucukcekmece, 34295, Turkey
Recruiting
Marmara University HospitalIstanbul, 34899, Turkey
Recruiting
Ege Universitesi Tip FakultesiIzmir, 35100, Turkey
Recruiting
Sakarya Universitesi Egitim ve Arastirma HastanesiSakarya, 54100, Turkey
Recruiting
Radiotherapy Center Cluj SRLFlore?ti, 407280, Romania
Withdrawn
UMass Memorial Medical Center - University Campus - OncologyWorcester, 01655-0002, United States
Recruiting
Centrul de Oncologie Sfantul NectarieCraiova, 200745, Romania
Recruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala IIBucuresti, 22328, Romania
Recruiting
Blacktown Cancer & Haematology CentreBlacktown, 2148, Australia
Recruiting
SC ONCOLAB SRLCraiova, 200385, Romania
Recruiting
UCLA Health Santa Monica Cancer CareSanta Monica, 90404, United States
Withdrawn
Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, 15-276, Poland
Withdrawn
Centro de Investigaciones Clínicas, Clínica ViedmaViedma, R8500, Argentina
Recruiting
Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati OsztályBudapest, 1145, Hungary
Withdrawn
Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabanya, 2800, Hungary
Recruiting
Fakultna nemocnica TrnavaTrnava, 91775, Slovakia
Recruiting
POKO Poprad s.r.o.Poprad, 058 01, Slovakia
Recruiting
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang ProvinceTaizhou, 317000, China
Recruiting
Prince of Wales HospitalHong Kong, MISSING, Hong Kong
Recruiting
Queen Mary HospitalHong Kong, MISSING, Hong Kong
Recruiting
Hong Kong United Oncology CentreKowloon, Hong Kong
Recruiting
Spitalul Clinic ColteaBucuresti, 30171, Romania
Withdrawn
Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózyOlomouc, 77900, Czech Republic
Recruiting
Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologieZlin, 762 75, Czech Republic
Recruiting
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)Brno, 602 00, Czech Republic
Recruiting
Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologieNový Jicín, 741 01, Czech Republic
Recruiting
Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddeleníOstrava - Vítkovice, 703 00, Czech Republic
Recruiting
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology DepartmentHangzhou, 310016, China
Recruiting
West China Hospital Sichuan UniversityChengdu, 610041, China
Recruiting
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)Essen, 45122, Germany
Recruiting
Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)Nürnberg, 90419, Germany
Withdrawn
R.J. Zuckerberg Cancer CenterNew Hyde Park, 11042, United States
Recruiting
Beijing chest hospital, Capital Medical UniversityBeijing, 101149, China
Not yet recruiting
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100000, China
Recruiting
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)chengdu, 610041, China
Recruiting
Jilin Cancer HospitalChangchun, 130000, China
Recruiting
Zhongshan Hospital, Fudan University - Oncology DepartmentShanghai, 200032, China
Recruiting
Queen Elizabeth Hospital Hong KongHong Kong, NA, Hong Kong
Recruiting
Hospital Universitrio Dr. José Eleuterio González. Servicio de OncologiaNuevo León, 64460, Mexico
Recruiting
Concord Repatriation General Hospital - Medical Oncology Clinical Trials UnitConcord, 2139, Australia
Recruiting
Austin Hospital - Olivia Newton John Cancer Research InstituteHeidelberg, 3084, Australia
Recruiting
University of the Sunshine CoastBuderim, 4556, Australia
Recruiting
MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology DepartmentUzhhorod, 88000, Ukraine
Recruiting
LLC "RDP Ukraine" - Medical DepartmentDnipro, 49102, Ukraine
Recruiting
Municipal Enterprise 'Rivne Regional Antitumor Center" of the Rivne Regional Council"Rivne, 33007, Ukraine
Recruiting
Kyiv City Clinical Oncology Center - Department of Chemotherapy #1Kyiv, 03115, Ukraine
Recruiting
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic CenterKropyvnytskyi, 25006, Ukraine
Recruiting
Medical Center LLC "Verum Expert Clinic"Kyiv, 3039, Ukraine
Recruiting
Volyn Regional Oncology CenterLutsk, 43018, Ukraine
Recruiting
Limited Liability Company "MedOffice Group Medical Center"Kyiv, 03189, Ukraine
Recruiting
Fujian Cancer HospitalFuzhou, 350014, China
Not yet recruiting
Hunan Cancer Hospital - Oncology DepartmentChangsha, 410013, China
Recruiting
Guangxi Medical University (GXMU) - Affiliated Tumor HospitalNanning, 530021, China
Not yet recruiting
Harbin Medical University Cancer HospitalHarbin, 150000, China
Recruiting
Hubei Cancer HospitalWuhan, 430079, China
Recruiting
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical UniversityNanjing, 210029, China
Recruiting
The People's Liberation Army General Hospital (Beijing 301 Hospital)Beijing, 100853, China
Recruiting
Union Hospi, Tongji Med College, Huazhong Univ. Scien&TechWuhan, 430023, China
Recruiting
Xiamen University - The First Affiliated HospitalXiamen, 361003, China
Recruiting
Zhejiang Cancer HospitalHangzhou, 310022, China
Recruiting
LinYi Cancer Hospital (Linyi Tumor Hospital)Linyi, 276001, China
Recruiting
Guangzhou Medical University - The First Affiliated HospitalGuangzhou, 510230, China
Recruiting
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Recruiting
Beacon HospitalPetaling Jaya, 46050, Malaysia
Recruiting
Sunway Medical CentreSubang Jaya, 47500, Malaysia
Recruiting
Sunway Medical Centre PenangPerai, 13700, Malaysia
Recruiting
University Malaya Medical CentreKuala Lumpur, 59100, Malaysia
Recruiting
Tan Tock Seng HospitalSingapore, 308433, Singapore
Not yet recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Not yet recruiting
National Taiwan University Hospital (NTUH) - Cancer Research CenterTaipei, 100225, Taiwan
Recruiting
UC San Diego Health - Moores Cancer CenterSan Diego, 92037, United States
Recruiting
Institutul Oncologic Prof. Dr. Ion ChiricutaCluj-Napoca, 400015, Romania
Not yet recruiting
CardioMed S.R.L.Cluj-Napoca, 400015, Romania
Not yet recruiting
Memorial Cancer Institute at MiramarMiramar, 33029, United States
Recruiting
University of Texas MD Anderson Cancer Center - Texas Medical CenterHouston, 77030, United States
Recruiting
Columbia Asia Hospital Bukit RimauShah Alam, 40460, Malaysia
Not yet recruiting
University Hospital Kebangsaan MalaysiaCheras, 56000, Malaysia
Recruiting
UC Medical Center - OncologyCincinnati, 45219, United States
Withdrawn
UT SouthwesternDallas, 75235, United States
Recruiting
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and OncologySan Francisco, 94158, United States
Recruiting
University of Minnesota Medical CenterMinneapolis, 55455, United States
Recruiting
Hospital Universitario Ramon Y Cajal - OncologiaMadrid, 28034, Spain
Not yet recruiting
Careggi University Hospital - Oncologia ClinicaFirenze, 50134, Italy
Recruiting
Ospedale San Raffaele s.r.l. - Oncologia MedicaMilano, 20132, Italy
Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia MedicaPalermo, 90146, Italy
Not yet recruiting
ASST Sette Laghi_Ospedale Macchi - OncologiaVarese, 21100, Italy
Recruiting
Ospedale Vito Fazzi Lecce - OncologiaLecce, 73100, Italy
Not yet recruiting
Brampton Civic Hospital - OncologyBrampton, L6R 3J7, Canada
Recruiting
Careggi University Hospital - Oncologia ClinicaFirenze, 50134, Italy
Recruiting
OncocenterTimisoara, 300166, Romania
Recruiting
S.C Ovidius Clinical Hospital SRL - Oncology DepartmentOvidiu, 905900, Romania
Not yet recruiting
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki PiersiowejWarsaw, 02-781, Poland
Not yet recruiting
Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und TumorimmunologieBerlin, 12203, Germany
Recruiting
HFR Freiburg – KantonsspitalFribourg, 1708, Switzerland
Recruiting
University of Illinois Hospital - Outpatient Cancer Care CenterChicago, 60612, United States
Recruiting
AdventHealth Cancer InstituteOrlando, 32804, United States
Withdrawn
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki PiersiowejWarsaw, 02-781, Poland
Not yet recruiting
Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und OnkologieFrankfurt, 60590, Germany
Not yet recruiting
Moffitt Cancer CenterTampa, 33612, United States
Not yet recruiting
Moffitt Cancer Center - Magnolia CampusTampa, 33612, United States
Not yet recruiting
Clinica Integral Internacional de Oncologia S. de R.L. de C.V.Puebla, 72530, Mexico
Not yet recruiting
Unidade Local Saúde Coimbra, E.P.ECoimbra, 3004-561, Portugal
Not yet recruiting
Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials UnitCardiff, CF14 2TL, United Kingdom
Recruiting
Allegheny General HospitalPittsburgh, 15212, United States
Not yet recruiting
Hopital Nord Laennec - Oncologie medicale thoracique et digestiveNantes, 44093, France
Not yet recruiting
Centre Antoine Lacassagne - Departement OncologieNice, 06100, France
Not yet recruiting
Piedmont Cancer Institute - AtlantaAtlanta, 30318, United States
Suspended
Virginia Commonwealth UniversityRichmond, 23298, United States
Not yet recruiting
John B. Amos Cancer CenterColumbus, 31904, United States
Not yet recruiting
?enry Durant Hospital Center-4th Oncology Department and Clinical Trials UnitAthens, 115 26, Greece
Not yet recruiting
Gleneagles Penang Medical CenterGeorge Town,, 10050, Malaysia
Not yet recruiting
Providence Oncology and Hematology Care Clinic WestsidePortland, 97225, United States

Primary Outcome

  • 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)
    date_rangeTime Frame:
    Up to approximately 2 years

Secondary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    Up to approximately 4 years.
  • 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)
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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)
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • Duration of response (DOR) as assessed by BICR
    BICR = blinded independent central review (BICR)
    date_rangeTime Frame:
    Up to approximately 4 years
  • Duration of response (DOR) as assessed by the investigator
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • Change from baseline in NSCLC-SAQ total score
    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • Time to deterioration in NSCLC-SAQ total score
    NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years
  • 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
    date_rangeTime Frame:
    Up to approximately 4 years

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2