一项研究旨在详细了解 BAY 2927088 在患有人表皮生长因子受体 2 (HER2) 基因突变的晚期非小细胞肺癌 (NSCLC) 受试者中的疗效以及与标准治疗相比的安全性 (SOHO-02)
2026年11月3日 更新者：Bayer
一项开放标签、随机、活性对照、多中心 3 期试验，旨在评估口服 BAY 2927088 与作为一线治疗的标准护理在局部晚期或转移性非小细胞肺癌患者中的疗效和安全性(NSCLC) 具有 HER2 激活突变
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly.
The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing.
The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation.
The study participants will receive one of the study treatments:
- Sevabertinib as a tablet taken by mouth twice a day
- Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover.
Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment.
During the study, the research team will:
- do scans such as CT, PET, MRI, or X-rays to check the cancer
- Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram.
- do pregnancy tests when needed
- ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
444
阶段
- 第三阶段
扩展访问
可用的
查看扩展访问记录。
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Bayer Clinical Trials Contact
- 电话号码：18888422937
- 邮箱：clinical-trials-contact@bayer.com
学习地点
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-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- 主动，不招人
- Beijing Cancer Hospital - Oncology Department
-
Beijing、Beijing Municipality、中国、100730
- 主动，不招人
- Beijing Hospital
-
Beijing、Beijing Municipality、中国、100853
- 尚未招聘
- The People's Liberation Army General Hospital (Beijing 301 Hospital)
-
Beijing、Beijing Municipality、中国、100021
- 尚未招聘
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Beijing、Beijing Municipality、中国、101149
- 主动，不招人
- Beijing chest hospital, Capital Medical University
-
-
Fujian
-
Fuzhou、Fujian、中国、350014
- 主动，不招人
- Fujian Cancer Hospital
-
Xiamen、Fujian、中国、361003
- 完全的
- Xiamen University - The First Affiliated Hospital
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510160
- 主动，不招人
- The first Affiliated Hospital of Guangzhou Medical University
-
-
Guangxi
-
Nanning、Guangxi、中国、530021
- 主动，不招人
- Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150000
- 撤销
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- 主动，不招人
- Hubei Cancer Hospital
-
Wuhan、Hubei、中国、430023
- 主动，不招人
- Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
-
-
Hunan
-
Changsha、Hunan、中国、410013
- 主动，不招人
- Hunan Cancer Hospital - Oncology Department
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 主动，不招人
- Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
-
Nanjing、Jiangsu、中国、210008
- 主动，不招人
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
-
Taizhou、Jiangsu、中国、317000
- 主动，不招人
- Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
-
-
Jilin
-
Changchun、Jilin、中国、130000
- 主动，不招人
- Jilin Cancer Hospital
-
-
Shandong
-
Jinan、Shandong、中国、250117
- 主动，不招人
- Shandong University - Shandong Cancer Hospital
-
Linyi、Shandong、中国、276001
- 主动，不招人
- LinYi Cancer Hospital (Linyi Tumor Hospital)
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200030
- 主动，不招人
- Shanghai Chest Hospital, Shanghai Jiaotong University
-
Shanghai、Shanghai Municipality、中国、200032
- 主动，不招人
- Zhongshan Hospital, Fudan University
-
-
Sichuan
-
Chengdu、Sichuan、中国、610041
- 主动，不招人
- West China Hospital Sichuan University
-
Chengdu、Sichuan、中国、610041
- 主动，不招人
- University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- 主动，不招人
- Zhejiang Cancer Hospital
-
Hangzhou、Zhejiang、中国、310016
- 主动，不招人
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
-
-
-
-
Capital Region / Region Hovedstaden
-
Copenhagen、Capital Region / Region Hovedstaden、丹麦、2100
- 主动，不招人
- Rigshospitalet Copenhagen University Hospital | Oncology Department
-
-
Central Denmark Region / Region Midtjylland
-
Aarhus N、Central Denmark Region / Region Midtjylland、丹麦、8200
- 完全的
- Aarhus Universitetshospital
-
Herning、Central Denmark Region / Region Midtjylland、丹麦、7400
- 撤销
- Regionshospitalet Gødstrup - Medicinsk afdeling
-
-
North Denmark Region / Region Nordjylland
-
Aalborg、North Denmark Region / Region Nordjylland、丹麦、9000
- 撤销
- Aalborg Universitetshospital - Onkologisk afdeling
-
-
Region of Southern Denmark / Region Syddanmark
-
Odense、Region of Southern Denmark / Region Syddanmark、丹麦、5000
- 主动，不招人
- Odense University Hospital | Svendborg Sygehus - Oncology Department
-
-
-
-
Dnipropetrovsk Oblast
-
Dnipro、Dnipropetrovsk Oblast、乌克兰、49102
- 尚未招聘
- LLC "RDP Ukraine" - Medical Department
-
-
Kirovohrad Oblast
-
Kropyvnytskyi、Kirovohrad Oblast、乌克兰、25006
- 尚未招聘
- Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
-
-
Kyiv City
-
Kyiv、Kyiv City、乌克兰、03115
- 尚未招聘
- Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
-
Kyiv、Kyiv City、乌克兰、03189
- 主动，不招人
- Limited Liability Company "MedOffice Group Medical Center"
-
Kyiv、Kyiv City、乌克兰、3039
- 尚未招聘
- Medical Center LLC "Verum Expert Clinic"
-
-
Rivne Oblast
-
Rivne、Rivne Oblast、乌克兰、33010
- 主动，不招人
- Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
-
-
Volyn Oblast
-
Lutsk、Volyn Oblast、乌克兰、43018
- 尚未招聘
- Regional Medical Oncology Centre_Oncology Chemotherapy Department
-
-
Zakarpattia Oblast
-
Uzhhorod、Zakarpattia Oblast、乌克兰、88000
- 尚未招聘
- MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
-
-
-
-
-
Jerusalem、以色列、91031
- 主动，不招人
- Shaare Zedek Medical Center - Oncology Institute
-
Tel Aviv、以色列、6423906
- 完全的
- Tel Aviv Sourasky Medical Center - Oncology Department
-
-
Central District
-
Ashdod、Central District、以色列、7747629
- 主动，不招人
- Assuta Ashdod Public Hospital (R.A)
-
-
Southern District
-
Beersheba、Southern District、以色列、8410101
- 完全的
- Clalit Health | Soroka Medical Center - Oncology department
-
-
-
-
Pazardzhik Province
-
Panagyurishte、Pazardzhik Province、保加利亚、4500
- 尚未招聘
- MHAT Uni Hospital
-
-
Pleven Province
-
Pleven、Pleven Province、保加利亚、5804
- 尚未招聘
- MHAT "Heart and brain" Pleven
-
-
Plovdiv Province
-
Plovdiv、Plovdiv Province、保加利亚、4109
- 撤销
- MHAT Park Hospital EOOD
-
Plovdiv、Plovdiv Province、保加利亚、4004
- 尚未招聘
- Complex Oncology Center - Plovdiv EOOD
-
-
Sofia City Province
-
Sofia、Sofia City Province、保加利亚、1404
- 招聘中
- Multiprofile Hospital for Active Treatment "Sveta Sofia"
-
Sofia、Sofia City Province、保加利亚、1797
- 撤销
- Specialized Hospital for Active Treatment of Oncology
-
Sofia、Sofia City Province、保加利亚、1797
- 尚未招聘
- University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
-
Sofia、Sofia City Province、保加利亚、1303
- 主动，不招人
- MHAT Serdikamed
-
-
Varna Province
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Varna、Varna Province、保加利亚、9010
- 尚未招聘
- MHAT Sveta Marina EAD
-
-
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V5Z 4E6
- 完全的
- BC Cancer | Vancouver
-
-
Ontario
-
Brampton、Ontario、加拿大、L6R 3J7
- 招聘中
- Brampton Civic Hospital | Oncology
-
Toronto、Ontario、加拿大、M5G 2C4
- 招聘中
- Princess Margaret Cancer Centre | Medical Oncology and Hematology
-
-
Quebec
-
Montreal、Quebec、加拿大、H3T 1E2
- 招聘中
- Jewish General Hospital | Pulmonary Oncology
-
-
-
-
-
Budapest、匈牙利、1145
- 撤销
- Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
-
-
Komárom-Esztergom
-
Tatabánya、Komárom-Esztergom、匈牙利、2800
- 撤销
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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-
-
-
-
Kaohsiung City、台湾、807377
- 完全的
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung、台湾、40705
- 招聘中
- Taichung Veterans General Hospital
-
Taichung、台湾、402306
- 主动，不招人
- Chung Shan Medical University Hospital
-
Tainan、台湾、704
- 主动，不招人
- National Cheng Kung University Hospital
-
Tainan、台湾、73657
- 完全的
- Chi-Mei Medical Center, Liouyine
-
Taipei、台湾、100
- 招聘中
- National Taiwan University Hospital
-
Taipei、台湾、11217
- 主动，不招人
- Taipei Veterans General Hospital
-
Taipei、台湾、100225
- 招聘中
- National Taiwan University Hospital (NTUH) - Cancer Research Center
-
-
-
-
-
Istanbul、土耳其（türkiye）、34899
- 完全的
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Izmir、土耳其（türkiye）、35100
- 主动，不招人
- Ege Universitesi Tip Fakultesi Hastanesi
-
Sakarya、土耳其（türkiye）、54100
- 尚未招聘
- Sakarya Universitesi Egitim ve Arastirma Hastanesi
-
-
Adana
-
Yüreğir、Adana、土耳其（türkiye）、1370
- 完全的
- Adana Sehir Egitim ve Arastirma Hastanesi
-
-
Aksaray
-
Bilkent Ankara、Aksaray、土耳其（türkiye）、6800
- 主动，不招人
- Ankara Bilkent Sehir Hastanesi
-
-
Ankara
-
Yenimahalle、Ankara、土耳其（türkiye）、6170
- 尚未招聘
- Ankara Etlik Sehir Hastanesi
-
-
Istanbul
-
Kadıköy、Istanbul、土耳其（türkiye）、34722
- 主动，不招人
- İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
-
Küçükçekmece、Istanbul、土耳其（türkiye）、34295
- 尚未招聘
- İ.A.Ü. VM Medical Park Florya Hastanesi
-
-
-
-
-
Puebla City、墨西哥、72530
- 尚未招聘
- Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
-
-
Mexico City
-
Mexico City、Mexico City、墨西哥、14080
- 完全的
- Instituto Nacional de Cancerología
-
Mexico City、Mexico City、墨西哥、3810
- 主动，不招人
- Oncare Viaducto Nápoles
-
-
Nuevo León
-
Monterrey、Nuevo León、墨西哥、64460
- 主动，不招人
- Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
-
San Pedro Garza García、Nuevo León、墨西哥、66220
- 主动，不招人
- ONCARE Treatment Center
-
-
State of Mexico
-
Naucalpan、State of Mexico、墨西哥、53100
- 主动，不招人
- Oncología Integral Satélite
-
-
-
-
-
Vienna、奥地利、1210
- 主动，不招人
- Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
-
-
State of Salzburg
-
Vienna、State of Salzburg、奥地利、1090
- 撤销
- Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
-
Vienna、State of Salzburg、奥地利、1090
- 撤销
- Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
-
-
State of Vienna
-
Vienna、State of Vienna、奥地利、1090
- 撤销
- Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
-
-
-
-
-
São Paulo、巴西、01323-030
- 招聘中
- A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
-
São Paulo、巴西、90020-090
- 招聘中
- Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
-
São Paulo、巴西、01308-050
- 招聘中
- Hospital Sirio Libanes
-
São Paulo、巴西、71635-610
- 撤销
- Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
-
-
Ceará
-
Fortaleza、Ceará、巴西、60810-180
- 招聘中
- Pronutrir Fortaleza - CE
-
-
Federal District
-
Brasília、Federal District、巴西、04538-132
- 招聘中
- Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
-
-
Pernambuco
-
Recife、Pernambuco、巴西、50070-480
- 招聘中
- Rede DoR Recife - PE
-
-
Rio Grande do Norte
-
Natal、Rio Grande do Norte、巴西、59040-000
- 招聘中
- Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
-
-
Santa Catarina
-
Blumenau、Santa Catarina、巴西、89010-340
- 招聘中
- Centro de Pesquisa da Clínica de Oncologia Reichow
-
-
São Paulo
-
Bauru、São Paulo、巴西、17033-490
- 招聘中
- NAIC - Instituto do Cancer
-
Jaú、São Paulo、巴西、14784-400
- 招聘中
- Fundacao Pio XII - Hospital de Cancer de Barretos
-
São José do Rio Preto、São Paulo、巴西、15090-000
- 撤销
- Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
-
-
-
-
-
Athens、希腊、11526
- 主动，不招人
- Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
-
Athens、希腊、11527
- 主动，不招人
- Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
-
Athens、希腊、11528
- 主动，不招人
- General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
-
Athens、希腊、12462
- 主动，不招人
- University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
-
Larissa、希腊、41110
- 撤销
- University General Hospital Of Larissa | Medical Oncology
-
Piraeus、希腊、18547
- 撤销
- Metropolitan Hospital- 4th Oncology Clinic
-
Pylaia Thessaloniki、希腊、555 35
- 撤销
- Genesis Hospital- Department of Pathological Oncology
-
Thessaloniki、希腊、57010
- 主动，不招人
- Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
-
-
Attica
-
Chaïdári、Attica、希腊、12462
- 撤销
- University General Hospital Attikon-4th Department of Internal Medicine
-
-
-
-
-
Berlin、德国、12203
- 尚未招聘
- Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
-
-
Baden-Wurttemberg
-
Stuttgart、Baden-Wurttemberg、德国、70376
- 完全的
- Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
-
-
Bavaria
-
Nuremberg、Bavaria、德国、90419
- 主动，不招人
- Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
-
-
Hesse
-
Frankfurt am Main、Hesse、德国、60590
- 尚未招聘
- Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
-
Giessen、Hesse、德国、35392
- 尚未招聘
- Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
-
-
North Rhine-Westphalia
-
Cologne、North Rhine-Westphalia、德国、51109
- 主动，不招人
- Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
-
Essen、North Rhine-Westphalia、德国、45147
- 主动，不招人
- Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
-
Hemer、North Rhine-Westphalia、德国、58675
- 主动，不招人
- Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
-
-
-
-
Apulia
-
Lecce、Apulia、意大利、73100
- 撤销
- Ospedale Vito Fazzi Lecce - Oncologia
-
-
Campania
-
Avellino、Campania、意大利、83100
- 完全的
- AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
-
-
Emilia-Romagna
-
Bologna、Emilia-Romagna、意大利、40138
- 主动，不招人
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
-
Meldola、Emilia-Romagna、意大利、47014
- 主动，不招人
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
-
-
Friuli Venezia Giulia
-
Aviano、Friuli Venezia Giulia、意大利、33081
- 主动，不招人
- Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
-
-
Lazio
-
Rome、Lazio、意大利、00144
- 主动，不招人
- I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
-
Rome、Lazio、意大利、00168
- 主动，不招人
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
-
-
Lombardy
-
Milan、Lombardy、意大利、20132
- 完全的
- Ospedale San Raffaele s.r.l. - Oncologia Medica
-
Milan、Lombardy、意大利、20133
- 主动，不招人
- Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
-
Milan、Lombardy、意大利、20141
- 主动，不招人
- Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
-
Rozzano、Lombardy、意大利、20089
- 主动，不招人
- Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
-
Varese、Lombardy、意大利、21100
- 撤销
- ASST Sette Laghi_Ospedale Macchi - Oncologia
-
-
Piedmont
-
Orbassano、Piedmont、意大利、10043
- 主动，不招人
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
-
-
Sicily
-
Palermo、Sicily、意大利、90146
- 主动，不招人
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
-
-
Tuscany
-
Florence、Tuscany、意大利、50134
- 主动，不招人
- Careggi University Hospital - Oncologia Clinica
-
-
Veneto
-
Padova、Veneto、意大利、35128
- 主动，不招人
- Istituto Oncologico Veneto_Padova - UOC Oncologia 2
-
Verona、Veneto、意大利、37134
- 撤销
- Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
-
-
-
-
Moravian-Silesian Region
-
Nový Jičín、Moravian-Silesian Region、捷克语、741 01
- 撤销
- Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
-
Ostrava - Vítkovice、Moravian-Silesian Region、捷克语、703 00
- 撤销
- Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
-
-
Olomouc Region
-
Olomouc、Olomouc Region、捷克语、779 00
- 撤销
- Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
-
-
South Moravian
-
Brno、South Moravian、捷克语、602 00
- 招聘中
- Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
-
-
Zlín
-
Zlín、Zlín、捷克语、762 75
- 撤销
- Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
-
-
-
-
-
Trnava、斯洛伐克、917 75
- 完全的
- Fakultna nemocnica Trnava
-
-
Presov
-
Poprad、Presov、斯洛伐克、058 01
- 撤销
- POKO Poprad s.r.o.
-
-
-
-
-
Singapore、新加坡、308433
- 完全的
- Tan Tock Seng Hospital
-
Singapore、新加坡、168583
- 主动，不招人
- National Cancer Center Singapore - Oncology Department
-
Singapore、新加坡、188770
- 完全的
- Raffles Cancer Centre
-
Singapore、新加坡、258499
- 主动，不招人
- OncoCare Cancer Centre | Gleneagles Medical Centre
-
Singapore、新加坡、329563
- 完全的
- Curie Oncology | Farrer
-
-
-
-
-
Fukuoka、日本、810-8563
- 主动，不招人
- National Hospital Organization Kyushu Medical Center
-
Niigata、日本、951-8566
- 主动，不招人
- Niigata Cancer Center Hospital
-
Osaka、日本、541-8567
- 主动，不招人
- Osaka International Cancer Institute
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、460-0001
- 主动，不招人
- National Hospital Organization Nagoya Medical Center
-
-
Chiba
-
Kashiwa、Chiba、日本、277-8577
- 主动，不招人
- National Cancer Center Hospital East
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、060-8648
- 招聘中
- Hokkaido University Hospital
-
-
Hyōgo
-
Himeji、Hyōgo、日本、670-8520
- 尚未招聘
- National Hospital Organization Himeji Medical Center
-
Kobe、Hyōgo、日本、650-0017
- 主动，不招人
- Kobe University Hospital
-
-
Kanagawa
-
Sagamihara、Kanagawa、日本、252-0375
- 主动，不招人
- Kitasato University Hospital
-
-
Miyagi
-
Sendai、Miyagi、日本、980-0873
- 主动，不招人
- Sendai Kousei Hospital
-
-
Osaka
-
Hirakata、Osaka、日本、573-1191
- 主动，不招人
- Kansai Medical University Hospital
-
Sakai、Osaka、日本、590-0197
- 尚未招聘
- Kindai University Hospital
-
-
Saitama
-
Kitaadachi、Saitama、日本、362-0806
- 主动，不招人
- Saitama Cancer Center
-
-
Tokyo
-
Bunkyo-ku、Tokyo、日本、113-8603
- 尚未招聘
- Nippon Medical School - Nippon Medical School Hospital - Cancer Center
-
-
Tottori
-
Yonago、Tottori、日本、683-8504
- 主动，不招人
- Tottori University Hospital
-
-
Yamaguchi
-
Ube、Yamaguchi、日本、755-0241
- 主动，不招人
- National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
-
-
-
-
Antwerp
-
Antwerp、Antwerp、比利时、2650
- 撤销
- Antwerp University Hospital | Oncology Department
-
-
Flemish Brabant
-
Leuven、Flemish Brabant、比利时、3000
- 主动，不招人
- UZ Leuven Gasthuisberg - Pneumology Department
-
-
West Flanders
-
Roeselare、West Flanders、比利时、8800
- 主动，不招人
- AZ Delta | Clinical Trial Center - Pneumology
-
-
-
-
Auvergne-Rhône-Alpes
-
La Tronche、Auvergne-Rhône-Alpes、法国、38700
- 完全的
- Centre Hospitalier Michallon Grenoble - Service pneumologie
-
Pierre-Bénite、Auvergne-Rhône-Alpes、法国、69310
- 主动，不招人
- hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
-
-
Brittany Region
-
Brest、Brittany Region、法国、29200
- 主动，不招人
- Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
-
-
Grand Est
-
Mulhouse、Grand Est、法国、68100
- 撤销
- hopital Emile Muller - Service Pneumologie
-
-
Hauts-de-France
-
Lille、Hauts-de-France、法国、59000
- 主动，不招人
- Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
-
-
New Aquitaine
-
Bordeaux、New Aquitaine、法国、33076
- 主动，不招人
- Institut Bergonie - Unicancer Nouvelle Aquitaine
-
Limoges、New Aquitaine、法国、87000
- 主动，不招人
- Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
-
-
Normandy
-
Rouen、Normandy、法国、76031
- 撤销
- CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
-
-
Occitanie
-
Montpellier、Occitanie、法国、34091
- 主动，不招人
- CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
-
-
Pays de la Loire Region
-
Nantes、Pays de la Loire Region、法国、44093
- 主动，不招人
- Hopital Nord Laennec - Oncologie medicale thoracique et digestive
-
Saint-Herblain、Pays de la Loire Region、法国、44800
- 主动，不招人
- Institut de Cancerologie Ouest - Saint-Herblain
-
-
Provence-Alpes-Côte d'Azur Region
-
Nice、Provence-Alpes-Côte d'Azur Region、法国、06100
- 主动，不招人
- Centre Antoine Lacassagne - Departement Oncologie
-
-
Île-de-France Region
-
Créteil、Île-de-France Region、法国、94010
- 主动，不招人
- Centre Hospitalier Intercommunal Creteil - Service de pneumologie
-
Paris、Île-de-France Region、法国、75014
- 撤销
- APHP - Hopital Cochin - Service de Pneumologie
-
Paris、Île-de-France Region、法国、75248
- 主动，不招人
- Institut Curie - Paris - Oncologie medicale
-
Suresnes、Île-de-France Region、法国、92150
- 撤销
- Hopital Foch - Oncologie digestive et thoracique
-
Villejuif、Île-de-France Region、法国、94800
- 主动，不招人
- Gustave Roussy - Departement Oncologie-Radiotherapie
-
-
-
-
Greater Poland Voivodeship
-
Poznan、Greater Poland Voivodeship、波兰、60-569
- 主动，不招人
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
-
-
Lower Silesian Voivodeship
-
Wroclaw、Lower Silesian Voivodeship、波兰、53-413
- 撤销
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
Masovian Voivodeship
-
Otwock、Masovian Voivodeship、波兰、05-400
- 撤销
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
-
Warsaw、Masovian Voivodeship、波兰、02-781
- 撤销
- Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
-
Warsaw、Masovian Voivodeship、波兰、01-138
- 撤销
- Instytut Gruzlicy i Chorob Pluc
-
-
Podlaskie Voivodeship
-
Bialystok、Podlaskie Voivodeship、波兰、15-276
- 撤销
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
-
Łódź Voivodeship
-
Lodz、Łódź Voivodeship、波兰、92-213
- 完全的
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
-
-
Świętokrzyskie Voivodeship
-
Kielce、Świętokrzyskie Voivodeship、波兰、25-734
- 撤销
- Swietokrzyskie Centrum Onkologii
-
-
-
-
New South Wales
-
Blacktown、New South Wales、澳大利亚、2148
- 主动，不招人
- NSW Health - Blacktown Hospital
-
Concord、New South Wales、澳大利亚、2139
- 完全的
- Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
-
Waratah、New South Wales、澳大利亚、2298
- 主动，不招人
- Calvary Mater Hospital Newcastle - Oncology
-
-
Queensland
-
Buderim、Queensland、澳大利亚、4556
- 撤销
- University of the Sunshine Coast
-
Toowoomba、Queensland、澳大利亚、4350
- 撤销
- Toowoomba Hospital Oncology Clinical Trials
-
-
Victoria
-
Heidelberg、Victoria、澳大利亚、3084
- 主动，不招人
- Austin Hospital - Olivia Newton John Cancer Research Institute
-
-
-
-
-
Lund、瑞典、221 85
- 主动，不招人
- Skånes Universitetssjukhus - Lund - Lungmedicin
-
-
Västerbotten County
-
Umeå、Västerbotten County、瑞典、901 85
- 完全的
- Norrlands Universitetssjukhus Umeå - Cancercentrum
-
-
-
-
-
Fribourg、瑞士、1708
- 撤销
- HFR Freiburg - Kantonsspital
-
-
Canton of Aargau
-
Baden、Canton of Aargau、瑞士、5404
- 主动，不招人
- Kantonsspital Baden
-
-
-
-
Bucharest Municipality
-
Bucharest、Bucharest Municipality、罗马尼亚、22328
- 主动，不招人
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
-
Bucharest、Bucharest Municipality、罗马尼亚、30171
- 撤销
- Spitalul Clinic Coltea
-
-
Cluj
-
Cluj-Napoca、Cluj、罗马尼亚、400015
- 撤销
- CardioMed S.R.L.
-
Cluj-Napoca、Cluj、罗马尼亚、400015
- 主动，不招人
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
-
Comuna Floresti
-
Florești、Comuna Floresti、罗马尼亚、407280
- 主动，不招人
- Radiotherapy Center Cluj SRL
-
-
Constanța County
-
Ovidiu、Constanța County、罗马尼亚、905900
- 撤销
- S.C Ovidius Clinical Hospital SRL - Oncology Department
-
-
Dolj
-
Craiova、Dolj、罗马尼亚、200385
- 撤销
- Sc Oncolab Srl
-
Craiova、Dolj、罗马尼亚、200745
- 主动，不招人
- Centrul de Oncologie Sfantul Nectarie
-
-
Timiș County
-
Timișoara、Timiș County、罗马尼亚、300166
- 撤销
- Oncocenter
-
-
-
-
California
-
Newport Beach、California、美国、92663
- 撤销
- Patty & George Hoag Cancer Center
-
San Diego、California、美国、92037
- 撤销
- UC San Diego Health - Moores Cancer Center
-
San Francisco、California、美国、94158
- 招聘中
- UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
-
Santa Monica、California、美国、90404
- 招聘中
- UCLA Health Santa Monica Cancer Care
-
-
Florida
-
Fort Lauderdale、Florida、美国、33316
- 招聘中
- The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
-
Miramar、Florida、美国、33029
- 撤销
- Memorial Cancer Institute at Miramar
-
Orlando、Florida、美国、32804
- 尚未招聘
- AdventHealth Cancer Institute Orlando
-
Tampa、Florida、美国、33612
- 撤销
- Moffitt Cancer Center - Magnolia Campus
-
-
Georgia
-
Atlanta、Georgia、美国、30318
- 招聘中
- Piedmont Healthcare - Atlanta
-
Columbus、Georgia、美国、31904
- 招聘中
- John B. Amos Cancer Center
-
-
Illinois
-
Chicago、Illinois、美国、60612
- 招聘中
- University of Illinois Hospital - Outpatient Cancer Care Center
-
Chicago、Illinois、美国、60637
- 撤销
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- 尚未招聘
- UM Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Worcester、Massachusetts、美国、01655
- 撤销
- UMass Memorial Medical Center - University Campus - Hematology/Oncology
-
-
Michigan
-
Farmington Hills、Michigan、美国、48334
- 撤销
- Profound Research -OMG - TriAtria Cancer Center
-
Royal Oak、Michigan、美国、48073
- 撤销
- Profound Research - OMG - Royal Oak Cancer Center
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- 撤销
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
-
-
New York
-
New Hyde Park、New York、美国、11042
- 撤销
- R.J. Zuckerberg Cancer Center
-
-
Ohio
-
Cincinnati、Ohio、美国、45219
- 招聘中
- UC Medical Center - Oncology
-
Maumee、Ohio、美国、43537
- 招聘中
- Taylor Cancer Research Center
-
-
Oregon
-
Portland、Oregon、美国、97213
- 撤销
- Providence Cancer Institute - Franz Clinic
-
Portland、Oregon、美国、97225
- 撤销
- Providence Oncology and Hematology Care Clinic Westside
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15212
- 招聘中
- Allegheny General Hospital
-
-
Texas
-
Dallas、Texas、美国、75235
- 撤销
- University Hospital Simmons Cancer Center Lung/Head Neck Clinic
-
Houston、Texas、美国、77030
- 招聘中
- The University of Texas MD Anderson Cancer Center - Texas Medical Center
-
-
-
-
Southwest Finland
-
Turku、Southwest Finland、芬兰、20520
- 撤销
- Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
-
-
Uusimaa
-
Helsinki、Uusimaa、芬兰、00180
- 撤销
- Docrates Mehiläinen Syöpäsairaala
-
-
-
-
Devon
-
Torquay、Devon、英国、TQ2 7AA
- 主动，不招人
- Torbay Hospital | Oncology
-
-
Northern Ireland
-
Belfast、Northern Ireland、英国、BT12 7AB
- 撤销
- Belfast City Hospital | Oncology
-
-
Surrey
-
Guildford、Surrey、英国、GU2 7XX
- 主动，不招人
- Royal Surrey County Hospital | Cancer Centre
-
-
Wales
-
Cardiff、Wales、英国、CF14 2TL
- 撤销
- Velindre Cancer Centre | Clinical Trials Unit
-
-
-
-
Gelderland
-
Nijmegen、Gelderland、荷兰、6500 HB
- 撤销
- Radboud University Medical Center | Afdeling Interne Geneeskunde
-
-
North Holland
-
Amsterdam、North Holland、荷兰、1066 CX
- 主动，不招人
- Nederlands Kanker Instituut
-
-
-
-
-
Lisbon、葡萄牙、1769-001
- 招聘中
- CHULN - Hospital Pulido Valente
-
Lisbon、葡萄牙、1400-038
- 完全的
- Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
-
Porto、葡萄牙、4200-072
- 招聘中
- IPO Porto
-
-
Beira Litoral
-
Coimbra、Beira Litoral、葡萄牙、3004-561
- 完全的
- Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
-
-
Porto District
-
Matosinhos Municipality、Porto District、葡萄牙、4464-513
- 招聘中
- Hospital Pedro Hispano | Clinical Research Center
-
-
-
-
-
A Coruña、西班牙、15006
- 撤销
- Complexo Hospitalario Universitario A Coruna | Oncologia
-
Barcelona、西班牙、08028
- 主动，不招人
- Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
-
Barcelona、西班牙、08035
- 主动，不招人
- Hospital Universitari Vall D Hebron | Oncologia
-
Barcelona、西班牙、08036
- 撤销
- Hospital Clinic De Barcelona | Oncologia
-
Madrid、西班牙、28034
- 撤销
- Hospital Universitario Ramon Y Cajal | Oncologia
-
Madrid、西班牙、28040
- 撤销
- Hospital Universitario Fundacion Jimenez Diaz | Oncologia
-
Madrid、西班牙、28009
- 撤销
- Hospital General Universitario Gregorio Maranon | Oncologia
-
Valencia、西班牙、46026
- 主动，不招人
- Hospital Universitario Y Politecnico La Fe | Oncologia
-
Valencia、西班牙、46009
- 撤销
- Fundacion Instituto Valenciano De Oncologia | Oncologia
-
-
Barcelona
-
Badalona、Barcelona、西班牙、08916
- 主动，不招人
- Hospital Germans Trias I Pujol | Oncologia
-
-
Madrid
-
Majadahonda、Madrid、西班牙、28222
- 主动，不招人
- Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
-
-
Navarre
-
Pamplona、Navarre、西班牙、31008
- 主动，不招人
- Hospital Universitario De Navarra | Oncologia
-
-
-
-
-
Buenos Aires、阿根廷、C1199ABB
- 撤销
- Hospital Italiano de Buenos Aires
-
Buenos Aires、阿根廷、C1431FWO
- 撤销
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
-
Buenos Aires、阿根廷、C1125 ABD
- 撤销
- Fundación Cenit para la Investigación en Neurociencias
-
Córdoba、阿根廷、X5008HHW
- 撤销
- Centro Médico Privado CEMAIC
-
-
Buenos Aires
-
TBC、Buenos Aires、阿根廷、B1841
- 撤销
- Instituto Argentino de Diagnostico y Tratamiento (IADT)
-
-
Río Negro Province
-
Viedma、Río Negro Province、阿根廷、R8500ACE
- 撤销
- Centro de Investigaciones Clínicas, Clínica Viedma
-
-
-
-
-
Seoul、韩国、03722
- 招聘中
- Severance Hospital | Oncology
-
Seoul、韩国、06351
- 招聘中
- Samsung Medical Center | Oncology
-
-
Gyeonggi-do
-
Suwon、Gyeonggi-do、韩国、16247
- 尚未招聘
- St Vincent's Hospital | Oncology
-
-
Gyeongsangnam-do
-
Jinju、Gyeongsangnam-do、韩国、52727
- 尚未招聘
- Gyeongsang National University Hospital | Oncology
-
Yangsan、Gyeongsangnam-do、韩国、50612
- 终止
- Pusan National University Yangsan Hospital | Pulmonology
-
-
Jeollanam-do
-
Hwasun-gun、Jeollanam-do、韩国、58128
- 尚未招聘
- Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
-
-
North Chungcheong
-
Chungcheongbuk-do、North Chungcheong、韩国、28644
- 尚未招聘
- Chungbuk National University Hospital | Hematology and Oncology
-
-
Seoul
-
Jongno -Gu、Seoul、韩国、03080
- 招聘中
- Seoul National University Hospital | Oncology
-
-
-
-
-
Kowloon、香港、00000
- 主动，不招人
- Hong Kong United Oncology Centre
-
-
Hong Kong SAR
-
Hong Kong、Hong Kong SAR、香港、00000
- 招聘中
- Prince of Wales Hospital
-
Hong Kong、Hong Kong SAR、香港、00000
- 招聘中
- Queen Elizabeth Hospital Hong Kong
-
Hong Kong、Hong Kong SAR、香港、00000
- 尚未招聘
- Queen Mary Hospital
-
-
-
-
Kuala Lumpur
-
Kuala Lumpur、Kuala Lumpur、马来西亚、59100
- 主动，不招人
- Universiti Malaya Medical Centre
-
-
Kuala Lumpur and Selangor
-
Cheras、Kuala Lumpur and Selangor、马来西亚、56000
- 撤销
- University Hospital Kebangsaan Malaysia
-
-
Pulau Pinang
-
George Town、Pulau Pinang、马来西亚、10050
- 尚未招聘
- Gleneagles Penang Medical Center
-
Perai、Pulau Pinang、马来西亚、13700
- 主动，不招人
- Sunway Medical Centre Penang
-
-
Selangor
-
Petaling Jaya、Selangor、马来西亚、46050
- 尚未招聘
- Beacon Hospital
-
Shah Alam、Selangor、马来西亚、40460
- 尚未招聘
- Columbia Asia Hospital Bukit Rimau
-
Subang Jaya、Selangor、马来西亚、47500
- 主动，不招人
- Sunway Medical Centre
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sevabertinib
Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. |
Tablet, oral |
|
有源比较器：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. |
Intravenous (IV) infusion IV infusion IV infusion IV infusion |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
研究者评估的缓解持续时间 (DOR)
大体时间：最长约 4 年
|
最长约 4 年
|
|
|
总生存（OS）
大体时间：大约4年。
|
大约4年。
|
|
|
研究人员评估的每个recist 1.1的客观响应率（ORR）
大体时间：长达大约4年
|
长达大约4年
|
|
|
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Up to approximately 4 years
|
BICR = blinded independent central review (BICR) |
Up to approximately 4 years
|
|
Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年8月28日
初级完成 (估计的)
2027年10月28日
研究完成 (估计的)
2029年6月27日
研究注册日期
首次提交
2024年6月5日
首先提交符合 QC 标准的
2024年6月5日
首次发布 (实际的)
2024年6月11日
研究记录更新
最后更新发布 (实际的)
2026年11月4日
上次提交的符合 QC 标准的更新
2026年11月3日
最后验证
2026年10月15日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 22615
- 2024-511319-91-00 (其他标识符：CTIS (EU))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.