account_circleRecruiting
Advanced non-small cell lung cancer, HER2 mutation
Bayer Identifier:
22615
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2024-511319-91-00
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)
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
278Trial Dates
August 2024 - April 2029Phase
Phase 3Could I Receive a placebo
NoProducts
BAY2927088Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
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Not yet recruiting | hopital Emile Muller - Service Pneumologie | Mulhouse, 68100, France |
Recruiting | Centre Hospitalier Intercommunal Creteil - Service de pneumologie | Créteil, 94010, France |
Not yet recruiting | Institut Bergonie - Unicancer Nouvelle Aquitaine | Bordeaux, 33076, France |
Recruiting | Institut Curie - Paris - Oncologie medicale | Paris, 75248, France |
Not yet recruiting | Institut de Cancerologie Ouest - Saint-Herblain | Saint-Herblain, 44800, France |
Not yet recruiting | Gustave Roussy - Departement Oncologie-Radiotherapie | VILLEJUIF CEDEX, 94805, France |
Withdrawn | Hospital de Base | Integrated Research Center | São José do Rio Preto, 15090-000, Brazil |
Not yet recruiting | Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia | Brasilia, 71635-610, Brazil |
Not yet recruiting | Pronutrir Fortaleza - CE | Fortaleza, 60810-180, Brazil |
Not yet recruiting | Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica | Natal, 59040-000, Brazil |
Recruiting | Hospital Sirio Libanes | Sao Paulo, 01308-050, Brazil |
Not yet recruiting | A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante | Sao Paulo, 01323-030, Brazil |
Not yet recruiting | Fundacao Pio XII - Hospital de Cancer de Barretos | Barretos, 14784-400, Brazil |
Not yet recruiting | Centro de Pesquisa da Clínica de Oncologia Reichow | Blumenau, 89010-340, Brazil |
Not yet recruiting | Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima | Sao Paulo, 04538-132, Brazil |
Not yet recruiting | Hopital Foch - Oncologie digestive et thoracique | Suresnes, 92150, France |
Recruiting | Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire | Lille, 59000, France |
Withdrawn | Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Buenos Aires, C1431FWO, Argentina |
Withdrawn | Hospital Italiano de Buenos Aires | Buenos Aires, C1199ABB, Argentina |
Not yet recruiting | Rede DoR Recife - PE | Recife, 50070-480, Brazil |
Not yet recruiting | NAIC - Instituto do Cancer | Bauru, 17033-490, Brazil |
Not yet recruiting | Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology | Porto Alegre, 90020-090, Brazil |
Not yet recruiting | UZ Leuven Gasthuisberg - Pneumology Department | Leuven, 3000, Belgium |
Not yet recruiting | AZ Delta | Clinical Trial Center - Pneumology | Roeselare, 8800, Belgium |
Not yet recruiting | Antwerp University Hospital | Oncology Department | Antwerpen, 2650, Belgium |
Not yet recruiting | IPO Porto | Porto, 4200-072, Portugal |
Recruiting | Kansai Medical University Hospital | Hirakata, 573-1191, Japan |
Not yet recruiting | National Hospital Organization Kyushu Medical Center | Fukuoka, 810-8563, Japan |
Not yet recruiting | National Hospital Organization Himeji Medical Center | Himeji, 670-8520, Japan |
Not yet recruiting | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Not yet recruiting | Tottori University Hospital | Yonago, 683-8504, Japan |
Recruiting | Saitama Cancer Center | Kitaadachi-gun, 362-0806, Japan |
Not yet recruiting | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Not yet recruiting | Osaka International Cancer Institute | Osaka, 541-8567, Japan |
Not yet recruiting | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Not yet recruiting | Sendai Kousei Hospital | Sendai, 980-0873, Japan |
Not yet recruiting | Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique | Limoges, 87000, France |
Not yet recruiting | hopital Arnaud de Villeneuve CHU Montpellier - service oncologie thoracique | Montpellier, 34091, France |
Not yet recruiting | Chungbuk National University Hospital | Cheongju-si, 28644, Korea,_republic_of |
Recruiting | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Not yet recruiting | Chonnam National University Hwasun Hospital | Hwasun Gun, 58128, Korea,_republic_of |
Not yet recruiting | Samsung Medical Center | Seoul, 06351, Korea,_republic_of |
Not yet recruiting | Gyeongsang National University Hospital | Jinju-si, 52727, Korea,_republic_of |
Not yet recruiting | Pusan National University Yangsan Hospital | Yangsan-si, 50612, Korea,_republic_of |
Not yet recruiting | The Oncology Institute of Hope and Innovation | Whittier, 90602, United States |
Withdrawn | Patty & George Hoag Cancer Center | Newport Beach, 92663, United States |
Not yet recruiting | Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and Hematology | Toronto, M5G 2C4, Canada |
Not yet recruiting | Nederlands Kanker Instituut | AMSTERDAM, 1066 CX, Netherlands |
Not yet recruiting | Kindai University Hospital | Osakasayama, 589-8511, Japan |
Withdrawn | Radboud University Medical Center | Afdeling Interne Geneeskunde | Nijmegen, 6500 HB, Netherlands |
Not yet recruiting | Curie Oncology | Farrer | Singapore, 329563, Singapore |
Not yet recruiting | Kobe University Hospital | Kobe, 650-0017, Japan |
Not yet recruiting | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Withdrawn | Fundación Cenit para la Investigación en Neurociencias | CABA, C1125 ABD, Argentina |
Not yet recruiting | Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia | Verona, 37134, Italy |
Not yet recruiting | Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica | Orbassano, 10043, Italy |
Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare | Roma, 00168, Italy |
Recruiting | Istituto Europeo di Oncologia s.r.l - Oncologia Toracica | Milano, 20141, Italy |
Recruiting | Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia | Rozzano, 20089, Italy |
Recruiting | Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 | Milano, 20133, Italy |
Recruiting | I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2 | Roma, 00128, Italy |
Not yet recruiting | Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica | Meldola, 47014, Italy |
Not yet recruiting | AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica | Avellino, 83100, Italy |
Recruiting | Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati | Aviano, 33081, Italy |
Recruiting | Shaare Zedek Medical Center (SZMC) | Jerusalem, 91031, Israel |
Not yet recruiting | National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital) | Ube, 755-0241, Japan |
Recruiting | Jewish General Hospital - Department of Pulmonary Oncology | Montreal, H3T 1E2, Canada |
Not yet recruiting | CHULN - Hospital Pulido Valente | Lisboa, 1769-001, Portugal |
Not yet recruiting | Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica | Lisboa, 1400-038, Portugal |
Not yet recruiting | Hospital Pedro Hispano | Clinical Research Center | Matosinhos, 4464-513, Portugal |
Not yet recruiting | BC Cancer - Vancouver | Vancouver, V5Z 4E6, Canada |
Withdrawn | Instituto Argentino de Diagnostico y Tratamiento (IADT) | TBC, TBC, Argentina |
Not yet recruiting | Soroka Medical Center- Legacy Heritage Cancer Center | Be'er Sheva, 8410101, Israel |
Not yet recruiting | The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC) | Garran, 2605, Australia |
Not yet recruiting | Calvary Mater Hospital Newcastle | Waratah, 2298, Australia |
Not yet recruiting | OncoCare Cancer Centre | Gleneagles Medical Centre | Singapore, 258499, Singapore |
Not yet recruiting | Belfast City Hospital | Belfast, BT12 7AB, United Kingdom |
Not yet recruiting | hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique | Pierre Bénite, 69310, France |
Recruiting | Centre Hospitalier Michallon Grenoble - Service pneumologie | La Tronche, 38700, France |
Recruiting | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Not yet recruiting | Hospital Clinic de Barcelona (Hospital Clinic i Provincial) | Barcelona, 08036, Spain |
Not yet recruiting | Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location | Badalona, 8916, Spain |
Recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica | Bologna, 40138, Italy |
Not yet recruiting | Hospital Quiron Dexeus | Barcelona, 08028, Spain |
Recruiting | Complejo Hospitalario de Navarra | Pamplona, 31008, Spain |
Not yet recruiting | Hospital Universitari i Politecnic La Fe | Oncologia | Valencia, 46026, Spain |
Not yet recruiting | Complejo Hospitalario Universitario A Coruna (CHUAC) | A Coruna, 15006, Spain |
Not yet recruiting | Fundacion Instituto Valenciano de Oncologia (IVO | Valencia, 46009, Spain |
Not yet recruiting | Niigata Cancer Center Hospital | Niigata, 951-8566, Japan |
Not yet recruiting | Nippon Medical School - Nippon Medical School Hospital - Cancer Center | Bunkyo-ku, 113-8603, Japan |
Withdrawn | Regionshospitalet Gødstrup - Medicinsk afdeling | Herning, 7400, Denmark |
Not yet recruiting | Rigshospitalet - Kræftbehandling | Copenhagen OE, 2100, Denmark |
Recruiting | Istituto Oncologico Veneto_Padova - UOC Oncologia 2 | Padova, 35128, Italy |
Recruiting | Beijing Cancer Hospital | Beijing, 100142, China |
Not yet recruiting | Beijing Hospital | Beijing, 100730, China |
Not yet recruiting | Shandong University - Shandong Cancer Hospital | Jinan, 250117, China |
Not yet recruiting | Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku | Otwock, 05-400, Poland |
Not yet recruiting | National Hospital Organization Nagoya Medical Center | Nagoya, 460-0001, Japan |
Recruiting | Kitasato University Hospital | Sagamihara, 252-0375, Japan |
Not yet recruiting | Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde | Salzburg, 5020, Austria |
Not yet recruiting | University of Maryland | Baltimore, 21201, United States |
Not yet recruiting | Torbay Hospital | Torquay, TQ2 7AA, United Kingdom |
Withdrawn | Centro Médico Privado CEMAIC | Córdoba, X5008HHW, Argentina |
Not yet recruiting | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Not yet recruiting | CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie | Rouen, 76031, France |
Recruiting | Shanghai Chest Hospital, Shanghai Jiaotong University | Shanghai, 200030, China |
Recruiting | Kantonsspital Baden | Baden, 5404, Switzerland |
Not yet recruiting | University General Hospital ATTIKON, Department of Internal Medicine IV | Chaidari, 12462, Greece |
Not yet recruiting | ONCARE Treatment Center | San Pedro Garza García, 66220, Mexico |
Recruiting | Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie | brest, 29200, France |
Not yet recruiting | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Not yet recruiting | Hospital General Universitario Gregorio Maranon | Oncologia | Madrid, 28009, Spain |
Not yet recruiting | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Not yet recruiting | University General Hospital of Athens "ATTIKON" | Chaidari, 12462, Greece |
Not yet recruiting | Bioclinic Thessaloniki | Thessaloniki, 54622, Greece |
Not yet recruiting | PAPANIKOLAOU General Hospital of Thessaloniki | Thessaloniki, 57010, Greece |
Not yet recruiting | University General Hospital of Larissa | Larissa, 41110, Greece |
Not yet recruiting | University of Athens Medical School- Alexandra General Hospital of Athens | Athens, 11528, Greece |
Recruiting | University of Athens Medical School-Sotiria General Hospital - 3rd Dept of Medicine & Medical Oncology | Athens, 11527, Greece |
Not yet recruiting | Raffles Cancer Centre | Singapore, 188770, Singapore |
Not yet recruiting | Odense University Hospital - Oncology Department | Odense C, 5000, Denmark |
Not yet recruiting | Chi-Mei Medical Center, Liouyine | Tainan, 73657, Taiwan |
Not yet recruiting | Chung Shan Medical University Hospital | Taichung, 402306, Taiwan |
Not yet recruiting | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Not yet recruiting | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Not yet recruiting | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City, 807377, Taiwan |
Not yet recruiting | Aalborg University hospital - oncology department | Aalborg, 9000, Denmark |
Recruiting | Aarhus Universitetshospital | Aarhus N, 8200, Denmark |
Not yet recruiting | Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik | Wien, 1210, Austria |
Not yet recruiting | Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie | Wien, 1090, Austria |
Not yet recruiting | Profound Research LLC | Farmington Hills, 48334, United States |
Not yet recruiting | Profound Research LLC | Farmington Hills, 48334, United States |
Not yet recruiting | Assuta Ashdod Public Hospital (R.A) | Ashdod, 7747629, Israel |
Not yet recruiting | Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin | Hemer, 58675, Germany |
Not yet recruiting | Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin | Stuttgart, 70376, Germany |
Not yet recruiting | Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik | Köln, 51109, Germany |
Not yet recruiting | Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie | Giessen, 35392, Germany |
Not yet recruiting | Providence Cancer Institute - Franz Clinic | Portland, 97213-2933, United States |
Not yet recruiting | Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III | Salzburg, 5020, Austria |
Recruiting | Royal Surrey County Hospital | Guildford, GU2 7XX, United Kingdom |
Not yet recruiting | The U Chicago Medicine Comprehensive Cancer Center | Chicago, 60805, United States |
Not yet recruiting | hopital cochin APHP - service de pneumologie | Paris, 75014, France |
Not yet recruiting | Instituto Nacional de Cancerología | México, 14080, Mexico |
Not yet recruiting | Oncare Viaducto Nápoles | CDMX, 3810, Mexico |
Not yet recruiting | Oncología Integral Satélite | Naucalpan, 53100, Mexico |
Not yet recruiting | Skåne University Hospital | Lund, 221 85, Sweden |
Not yet recruiting | MHAT "Heart and brain" Pleven | Pleven, 5804, Bulgaria |
Not yet recruiting | MHAT Serdika | Sofia, 1632, Bulgaria |
Not yet recruiting | MHAT Sofiamed | Sofia, 1797, Bulgaria |
Not yet recruiting | MHAT Uni Hospital | Panagyurishte, 4500, Bulgaria |
Not yet recruiting | Specialized Hospital for Active Treatment of Oncology | Sofia, 1797, Bulgaria |
Not yet recruiting | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Not yet recruiting | Multiprofile Hospital for Active Treatment "Sveta Sofia" | Sofia, 1404, Bulgaria |
Not yet recruiting | MHAT Park Hospital EOOD | Plovdiv, 4109, Bulgaria |
Not yet recruiting | Complex Oncology Center - Plovdiv EOOD | Plovdiv, 4004, Bulgaria |
Not yet recruiting | Metropolitan Hospital- 4th Oncology Clinic | Piraeus, 18547, Greece |
Not yet recruiting | Docrates Mehiläinen Syöpäsairaala | Helsinki, FIN-00180, Finland |
Not yet recruiting | Turun yliopistollinen keskussairaala | Turku, 20521, Finland |
Not yet recruiting | SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow | Lodz, 92-213, Poland |
Not yet recruiting | Swietokrzyskie Centrum Onkologii | Kielce, 25-734, Poland |
Not yet recruiting | Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Poznan, 60-569, Poland |
Not yet recruiting | Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw, 53-413, Poland |
Not yet recruiting | Norrland University Hospital - Cancercentrum | Umeå, 90185, Sweden |
Not yet recruiting | Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi | Kadikoy, 34722, Turkey |
Not yet recruiting | Adana Sehir Egitim ve Arastirma Hastanesi | Yüregir, 1370, Turkey |
Not yet recruiting | Ankara Bilkent Sehir Hastanesi | Bilkent ankara, 6800, Turkey |
Not yet recruiting | Ankara Etlik Sehir Hastanesi | Yenimahalle, 6170, Turkey |
Not yet recruiting | I.A.Ü. VM Medical Park Florya Hastanesi | Kucukcekmece, 34295, Turkey |
Not yet recruiting | Marmara University Hospital | Istanbul, 34899, Turkey |
Not yet recruiting | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Not yet recruiting | Sakarya Universitesi Egitim ve Arastirma Hastanesi | Sakarya, 54100, Turkey |
Not yet recruiting | Radiotherapy Center Cluj SRL | Flore?ti, 407280, Romania |
Withdrawn | UMass Memorial Medical Center - University Campus | Worcester, 01655-0002, United States |
Not yet recruiting | Centrul de Oncologie Sfantul Nectarie | Craiova, 200745, Romania |
Not yet recruiting | Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II | Bucuresti, 22328, Romania |
Not yet recruiting | Blacktown Cancer & Haematology Centre | Blacktown, 2148, Australia |
Not yet recruiting | SC ONCOLAB SRL | Craiova, 200385, Romania |
Recruiting | University of California Los Angeles (UCLA) - Cancer Care - Santa Monica | Santa Monica, 90404-2023, United States |
Withdrawn | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, 15-276, Poland |
Withdrawn | Centro de Investigaciones Clínicas, Clínica Viedma | Viedma, R8500, Argentina |
Not yet recruiting | Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály | Budapest, 1145, Hungary |
Withdrawn | Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabanya, 2800, Hungary |
Not yet recruiting | Fakultna nemocnica Trnava | Trnava, 91775, Slovakia |
Not yet recruiting | POKO Poprad s.r.o. | Poprad, 058 01, Slovakia |
Recruiting | Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province | Taizhou, 317000, China |
Not yet recruiting | Prince of Wales Hospital | Hong Kong, MISSING, Hong Kong |
Not yet recruiting | Queen Mary Hospital | Hong Kong, MISSING, Hong Kong |
Not yet recruiting | Hong Kong United Oncology Centre | Kowloon, Hong Kong |
Not yet recruiting | Spitalul Clinic Coltea | Bucuresti, 30171, Romania |
Withdrawn | Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy | Olomouc, 77900, Czech Republic |
Not yet recruiting | Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie | Zlin, 762 75, Czech Republic |
Not yet recruiting | Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP) | Brno, 602 00, Czech Republic |
Not yet recruiting | Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologie | Nový Jicín, 741 01, Czech Republic |
Not yet recruiting | Vitkovicka nemocnice a.s. | Ostrava, 703 84, Czech Republic |
Recruiting | Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine | Hangzhou, 310016, China |
Recruiting | West China Hospital Sichuan University | Chengdu, 610041, China |
Not yet recruiting | Universitaetsklinikum Essen - Innere Klinik (Tumorforschung) | Essen, 45122, Germany |
Not yet recruiting | Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde) | Nürnberg, 90419, Germany |
Withdrawn | Northwell Health Cancer Institute - R.J. Zuckerberg Cancer Center (Monter Cancer Center) - Center for Advanced Medicine Location | New Hyde Park, 11042-1118, United States |
Recruiting | Beijing chest hospital, Capital Medical University | Beijing, 101149, China |
Not yet recruiting | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing, 100000, China |
Recruiting | University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital) | chengdu, 610041, China |
Recruiting | Jilin Cancer Hospital | Changchun, 130000, China |
Not yet recruiting | Fudan University - Zhongshan Hospital | Shanghai, 200032, China |
Not yet recruiting | Queen Elizabeth Hospital Hong Kong | Hong Kong, NA, Hong Kong |
Not yet recruiting | Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia | Nuevo León, 64460, Mexico |
Not yet recruiting | Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit | Concord, 2139, Australia |
Not yet recruiting | Austin Hospital - Olivia Newton John Cancer Research Institute | Heidelberg, 3084, Australia |
Not yet recruiting | University of the Sunshine Coast | Buderim, 4556, Australia |
Not yet recruiting | MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department | Uzhhorod, 88000, Ukraine |
Not yet recruiting | LLC "RDP Ukraine" - Medical Department | Dnipro, 49102, Ukraine |
Not yet recruiting | Rivne regional antitumor hospital | Rivne, 33007, Ukraine |
Not yet recruiting | Kyiv City Clinical Oncology Center - Department of Chemotherapy #1 | Kyiv, 03115, Ukraine |
Not yet recruiting | Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center | Kropyvnytskyi, 25006, Ukraine |
Not yet recruiting | Medical Center LLC "Verum Expert Clinic" | Kyiv, 3039, Ukraine |
Not yet recruiting | Volyn Regional Oncology Center | Lutsk, 43018, Ukraine |
Not yet recruiting | Limited Liability Company "MedOffice Group Medical Center" | Kyiv, 03189, Ukraine |
Not yet recruiting | Fujian Cancer Hospital | Fuzhou, 350014, China |
Not yet recruiting | Hunan Cancer Hospital | Changsha, 410013, China |
Not yet recruiting | Guangxi Medical University (GXMU) - Affiliated Tumor Hospital | Nanning, 530021, China |
Not yet recruiting | Harbin Medical University Cancer Hospital | Harbin, 150000, China |
Recruiting | Hubei Cancer Hospital | Wuhan, 430079, China |
Recruiting | Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University | Nanjing, 210029, China |
Not yet recruiting | The People's Liberation Army General Hospital (Beijing 301 Hospital) | Beijing, 100853, China |
Not yet recruiting | Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech | Wuhan, 430023, China |
Not yet recruiting | Xiamen University - The First Affiliated Hospital | Xiamen, 361003, China |
Recruiting | Zhejiang Cancer Hospital | Hangzhou, 310022, China |
Recruiting | LinYi Cancer Hospital (Linyi Tumor Hospital) | Linyi, 276001, China |
Not yet recruiting | Guangzhou Medical University - The First Affiliated Hospital | Guangzhou, 510230, China |
Not yet recruiting | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Not yet recruiting | Beacon Hospital | Petaling Jaya, Selangor, 46050, Malaysia |
Recruiting | Sunway Medical Centre | Subang Jaya, 47500, Malaysia |
Not yet recruiting | Sunway Medical Centre Penang | Perai, 13700, Malaysia |
Recruiting | University Malaya Medical Centre | Kuala Lumpur, 59100, Malaysia |
Not yet recruiting | Tan Tock Seng Hospital | Singapore, 308433, Singapore |
Not yet recruiting | National Taiwan University Hospital | Taipei, 100, Taiwan |
Not yet recruiting | National Taiwan University Hospital (NTUH) - Cancer Research Center | Taipei, 100225, Taiwan |
Not yet recruiting | UC San Diego Health - Moores Cancer Center | San Diego, 92093-1503, United States |
Not yet recruiting | Institutul Oncologic Prof. Dr. Ion Chiricuta | Cluj-Napoca, 400015, Romania |
Not yet recruiting | CardioMed S.R.L. | Cluj-Napoca, 400015, Romania |
Not yet recruiting | Memorial Cancer Institute at Miramar | Miramar, 33029, United States |
Recruiting | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Not yet recruiting | Columbia Asia Hospital Bukit Rimau | Shah Alam, 40460, Malaysia |
Not yet recruiting | University Hospital Kebangsaan Malaysia | Cheras, 56000, Malaysia |
Not yet recruiting | University of Cincinnati Medical Center | Cincinnati, 45219-2316, United States |
Withdrawn | UT Southwestern | Dallas, 75235, United States |
Not yet recruiting | University of California San Francisco (UCSF) - Thoracic Surgery and Oncology Clinic | San Francisco, 94115-3010, United States |
Not yet recruiting | University of Minnesota Medical Center | Minneapolis, 55455, United States |
Not yet recruiting | Hospital Ramón y Cajal | Oncología | Madrid, 28034, Spain |
Not yet recruiting | Careggi University Hospital - Oncologia Clinica | Firenze, 50134, Italy |
Not yet recruiting | Ospedale San Raffaele s.r.l. - Oncologia Medica | Milano, 20132, Italy |
Not yet recruiting | Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica | Palermo, 90146, Italy |
Not yet recruiting | ASST Sette Laghi_Ospedale Macchi - Oncologia | Varese, 21100, Italy |
Not yet recruiting | Ospedale Vito Fazzi Lecce - Oncologia | Lecce, 73100, Italy |
Not yet recruiting | Brampton Civic Hospital - Oncology | Brampton, L6R 3J7, Canada |
Not yet recruiting | Careggi University Hospital - Oncologia Clinica | Firenze, 50134, Italy |
Not yet recruiting | Oncocenter | Timisoara, 300166, Romania |
Not yet recruiting | S.C Ovidius Clinical Hospital SRL - Oncology Department | Ovidiu, 905900, Romania |
Not yet recruiting | Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej | Warsaw, 02-781, Poland |
Not yet recruiting | Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie | Berlin, 12203, Germany |
Not yet recruiting | HFR Freiburg – Kantonsspital | Fribourg, 1708, Switzerland |
Not yet recruiting | University of Illinois at Chicago | Chicago, 60607, United States |
Not yet recruiting | AdventHealth Cancer Institute | Orlando, 32804, United States |
Not yet recruiting | Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej | Warsaw, 02-781, Poland |
Not yet recruiting | Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie | Frankfurt, 60590, Germany |
Not yet recruiting | Moffitt Cancer Center | Tampa, 33612, United States |
Suspended | Moffitt Cancer Center | Tampa, 33612, United States |
Not yet recruiting | Clinica Integral Internacional de Oncologia S. de R.L. de C.V. | Puebla, 72530, Mexico |
Not yet recruiting | Centro Hospitalar e Universitario de Coimbra EPE (CHUC) | Coimbra, 3004-561, Portugal |
Not yet recruiting | Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials Unit | Cardiff, CF14 2TL, United Kingdom |
Not yet recruiting | Allegheny General Hospital | Pittsburgh, 15212, United States |
Primary Outcome
- Progression free survival (PFS) per RECIST 1.1 as assessed by BICRRECIST 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 BICRRECIST 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 investigatorRECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1date_rangeTime Frame:Up to approximately 4 years
- Objective Response Rate (ORR) as assessed by the investigatordate_rangeTime Frame:Up to approximately 4 years
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICRRECIST 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 investigatorRECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1date_rangeTime Frame:Up to approximately 4 years
- Duration of response (DOR) as assessed by BICRBICR = blinded independent central review (BICR)date_rangeTime Frame:Up to approximately 4 years
- Duration of response (DOR) as assessed by the investigatordate_rangeTime Frame:Up to approximately 4 years
- Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severityCTCAE = common terminology criteria for adverse events; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse eventdate_rangeTime Frame:Up to approximately 4 years
- Change from baseline in NSCLC-SAQ total scoreNSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnairedate_rangeTime Frame:Up to approximately 4 years
- Change from baseline in NSCLC-SAQ individual domain scoresNSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetitedate_rangeTime Frame:Up to approximately 4 years
- Time to deterioration in NSCLC-SAQ total scoreNSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnairedate_rangeTime Frame:Up to approximately 4 years
- Time to deterioration in NSCLC-SAQ individual domain scoresNSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetitedate_rangeTime Frame:Up to approximately 4 years
- Time to deterioration in EORTC QLQ-C30 physical functioning domain scoreEORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30date_rangeTime Frame:Up to approximately 4 years
- Change from baseline in EORTC QLQ-C30 physical functioning domain scoreEORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of lifedate_rangeTime Frame:Up to approximately 4 years
- Change from baseline in EORTC QLQ-C30 global health status/QoLEORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of lifedate_rangeTime Frame:Up to approximately 4 years
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
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