A Study to Learn More About How Well 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 in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)
研究单位：[1]Bayer[2]Hoag Memorial Hospital - Center for Research & Education,Newport Beach,California,United States,92663[3]UC San Diego Health - Moores Cancer Center,San Diego,California,United States,92093-1503[4]University of California Los Angeles (UCLA) - Cancer Care - Santa Monica,Santa Monica,California,United States,90404-2023[5]The Oncology Institute of Hope and Innovation,Whittier,California,United States,90602[6]The U Chicago Medicine Comprehensive Cancer Center,Chicago,Illinois,United States,60805[7]University of Maryland,Baltimore,Maryland,United States,21201[8]UMass Memorial Medical Center - University Campus,Worcester,Massachusetts,United States,01655-0002[9]Profound Research LLC,Farmington Hills,Michigan,United States,48334[10]Northwell Health Cancer Institute - R.J. Zuckerberg Cancer Center (Monter Cancer Center) - Center for Advanced Medicine Location,New Hyde Park,New York,United States,11042-1118[11]Providence Cancer Institute - Franz Clinic,Portland,Oregon,United States,97213-2933[12]Fundación Cenit para la Investigación en Neurociencias,Caba,Ciudad Auton. De Buenos Aires,Argentina,C1125 ABD[13]Hospital Italiano de Buenos Aires,Buenos Aires,Argentina,C1199ABB[14]Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC),Buenos Aires,Argentina,C1431FWO[15]Centro Médico Privado CEMAIC,Córdoba,Argentina,X5008HHW[16]Instituto Argentino de Diagnostico y Tratamiento (IADT),TBC,Argentina,TBC[17]Centro de Investigaciones Clínicas, Clínica Viedma,Viedma,Argentina,R8500[18]Blacktown Cancer & Haematology Centre,Blacktown,New South Wales,Australia,2148[19]Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit,Concord,New South Wales,Australia,2139[20]Calvary Mater Hospital Newcastle,Waratah,New South Wales,Australia,2298[21]University of the Sunshine Coast,Buderim,Australia,4556[22]The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC),Garran,Australia,2605[23]Austin Hospital - Olivia Newton John Cancer Research Institute,Heidelberg,Australia,3084[24]Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III,Salzburg,Austria,5020[25]Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde,Salzburg,Austria,5020[26]Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie,Wien,Austria,1090[27]Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik,Wien,Austria,1210[28]Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling,Edegem,Belgium,2650[29]UZ Leuven Gasthuisberg,Leuven,Belgium,3000[30]AZ Delta | Clinical Trial Center - Pneumology,Roeselare,Belgium,8800[31]Rede DoR Recife - PE,Recife,Pernambuco,Brazil,50070-480[32]Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica,Natal,Rio Grande Do Norte,Brazil,59040-000[33]Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology,Porto Alegre,Rio Grande Do Sul,Brazil,90020-090[34]Fundacao Pio XII - Hospital de Cancer de Barretos,Barretos,Sao Paulo,Brazil,14784-400[35]Hospital de Base | Integrated Research Center,São José do Rio Preto,Sao Paulo,Brazil,15090-000[36]NAIC - Instituto do Cancer,Bauru,Brazil,17033-490[37]Clinica de Oncologia Reichow,Blumenau,Brazil,89010-340[38]Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia,Brasilia,Brazil,71635-610[39]Pronutrir Fortaleza - CE,Fortaleza,Brazil,60810-180[40]A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante,Sao Paulo,Brazil,01323-030[41]Hospital Sirio Libanes,Sao Paulo,Brazil,01409-000[42]Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima,Sao Paulo,Brazil,04538-132[43]MHAT Uni Hospital,Panagyurishte,Pazardzhik,Bulgaria,4500[44]MHAT "Heart and brain" Pleven,Pleven,Bulgaria,5804[45]Complex Oncology Center - Plovdiv EOOD,Plovdiv,Bulgaria,4004[46]MHAT Park Hospital EOOD,Plovdiv,Bulgaria,4109[47]Multiprofile Hospital for Active Treatment "Sveta Sofia",Sofia,Bulgaria,1404[48]MHAT Serdika,Sofia,Bulgaria,1632[49]MHAT Sofiamed,Sofia,Bulgaria,1797[50]Specialized Hospital for Active Treatment of Oncology,Sofia,Bulgaria,1797[51]MHAT Sveta Marina EAD,Varna,Bulgaria,9010[52]Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology,Toronto,Ontario,Canada,M5G 2C4[53]Jewish General Hospital - Department of Pulmonary Oncology,Montreal,Quebec,Canada,H3T 1E2[54]BC Cancer - The Vancouver Centre,Vancouver,Canada,V5Z 4E6[55]Fujian Cancer Hospital,Fuzhou,Fujian,China,350014[56]Hunan Cancer Hospital,Changsha,Hunan,China,410013[57]NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School,Nanjing,Jiangsu,China,210008[58]Jilin Cancer Hospital,Changchun,Jilin,China,130000[59]West China Hospital Sichuan University,Chengdu,Sichuan,China,610041[60]Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine,Hangzhou,Zhejiang,China,310016[61]Cancer Hospital, Chinese Academy of Medical Sciences,Beijing,China,100000[62]Beijing Cancer Hospital,Beijing,China,100142[63]Beijing Hospital,Beijing,China,100730[64]Beijing chest hospital, Capital Medical University,Beijing,China,101149[65]The People's Liberation Army General Hospital (Beijing 301 Hospital),Beijing,China[66]University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital),Chengdu,China,610041[67]Guangzhou Medical University - The First Affiliated Hospital,Guangzhou,China[68]Zhejiang Cancer Hospital,Hangzhou,China[69]Harbin Medical University Cancer Hospital,Harbin,China[70]Shandong University - Shandong Cancer Hospital,Jinan,China,250117[71]LinYi Cancer Hospital (Linyi Tumor Hospital),Linyi,China[72]Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital),Nanjing,China[73]Guangxi Medical University (GXMU) - Affiliated Tumor Hospital,Nanning,China[74]Shanghai Chest Hospital, Shanghai Jiaotong University,Shanghai,China,200030[75]Fudan University - Zhongshan Hospital,Shanghai,China,200032[76]Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province,Taizhou,China,317000[77]Hubei Cancer Hospital,Wuhan,China
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.
