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 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.
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 |
---|---|---|
Recruiting | hopital Emile Muller - Service Pneumologie | Mulhouse, 68100, France |
Recruiting | Centre Hospitalier Intercommunal Creteil - Service de pneumologie | Créteil, 94010, France |
Recruiting | Institut Bergonie - Unicancer Nouvelle Aquitaine | Bordeaux, 33076, France |
Recruiting | Institut Curie - Paris - Oncologie medicale | Paris, 75248, France |
Recruiting | Institut de Cancerologie Ouest - Saint-Herblain | Saint-Herblain, 44800, France |
Recruiting | Gustave Roussy - Departement Oncologie-Radiotherapie | Villejuif, 94800, France |
Withdrawn | Hospital de Base | Integrated Research Center | São José do Rio Preto, 15090-000, Brazil |
Recruiting | Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia | Brasilia, 71635-610, Brazil |
Recruiting | Pronutrir Fortaleza - CE | Fortaleza, 60810-180, Brazil |
Recruiting | Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica | Natal, 59040-000, Brazil |
Recruiting | Hospital Sirio Libanes | Sao Paulo, 01308-050, Brazil |
Recruiting | A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante | Sao Paulo, 01323-030, Brazil |
Recruiting | Fundacao Pio XII - Hospital de Cancer de Barretos | Barretos, 14784-400, Brazil |
Recruiting | Centro de Pesquisa da Clínica de Oncologia Reichow | Blumenau, 89010-340, Brazil |
Recruiting | Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima | Sao Paulo, 04538-132, Brazil |
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 |
Recruiting | Rede DoR Recife - PE | Recife, 50070-480, Brazil |
Recruiting | NAIC - Instituto do Cancer | Bauru, 17033-490, Brazil |
Recruiting | Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology | Porto Alegre, 90020-090, Brazil |
Recruiting | UZ Leuven Gasthuisberg - Pneumology Department | Leuven, 3000, Belgium |
Recruiting | AZ Delta | Clinical Trial Center - Pneumology | Roeselare, 8800, Belgium |
Recruiting | Antwerp University Hospital | Oncology Department | Antwerpen, 2650, Belgium |
Recruiting | IPO Porto | Porto, 4200-072, Portugal |
Recruiting | Kansai Medical University Hospital | Hirakata, 573-1191, Japan |
Recruiting | National Hospital Organization Kyushu Medical Center | Fukuoka, 810-8563, Japan |
Recruiting | National Hospital Organization Himeji Medical Center | Himeji, 670-8520, Japan |
Recruiting | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Recruiting | Tottori University Hospital | Yonago, 683-8504, Japan |
Recruiting | Saitama Cancer Center | Kitaadachi-gun, 362-0806, Japan |
Recruiting | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Recruiting | Osaka International Cancer Institute | Osaka, 541-8567, Japan |
Recruiting | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Recruiting | Sendai Kousei Hospital | Sendai, 980-0873, Japan |
Recruiting | Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique | Limoges, 87000, France |
Recruiting | CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique | Montpellier, 34091, France |
Recruiting | Chungbuk National University Hospital | Cheongju-si, 28644, Korea,_republic_of |
Recruiting | Severance Hospital, Yonsei University Health System - Oncology Department | Seoul, 03722, Korea,_republic_of |
Recruiting | Chonnam National University Hwasun Hospital | Hwasun Gun, 58128, Korea,_republic_of |
Recruiting | Samsung Medical Center - Oncology Department | Seoul, 06351, Korea,_republic_of |
Recruiting | Gyeongsang National University Hospital | Jinju-si, 52727, Korea,_republic_of |
Recruiting | Pusan National University Yangsan Hospital | Yangsan-si, 50612, Korea,_republic_of |
Recruiting | The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street | Fort Lauderdale, 33316, United States |
Withdrawn | Patty & George Hoag Cancer Center | Newport Beach, 92663, United States |
Recruiting | Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and Hematology | Toronto, M5G 2C4, Canada |
Recruiting | Nederlands Kanker Instituut | AMSTERDAM, 1066 CX, Netherlands |
Recruiting | Kindai University Hospital | Osakasayama, 589-8511, Japan |
Withdrawn | Radboud University Medical Center | Afdeling Interne Geneeskunde | Nijmegen, 6500 HB, Netherlands |
Recruiting | Curie Oncology | Farrer | Singapore, 329563, Singapore |
Recruiting | Kobe University Hospital | Kobe, 650-0017, Japan |
Recruiting | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Withdrawn | Fundación Cenit para la Investigación en Neurociencias | CABA, C1125 ABD, Argentina |
Recruiting | Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia | Verona, 37134, Italy |
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 |
Recruiting | Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica | Meldola, 47014, Italy |
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 |
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 |
Recruiting | CHULN - Hospital Pulido Valente | Lisboa, 1769-001, Portugal |
Recruiting | Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica | Lisboa, 1400-038, Portugal |
Recruiting | Hospital Pedro Hispano | Clinical Research Center | Matosinhos, 4464-513, Portugal |
Not yet recruiting | BC Cancer - Vancouver Site | Vancouver, V5Z 4E6, Canada |
Withdrawn | Instituto Argentino de Diagnostico y Tratamiento (IADT) | TBC, TBC, Argentina |
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 |
Recruiting | Calvary Mater Hospital Newcastle | Waratah, 2298, Australia |
Recruiting | OncoCare Cancer Centre | Gleneagles Medical Centre | Singapore, 258499, Singapore |
Not yet recruiting | Belfast City Hospital | Belfast, BT12 7AB, United Kingdom |
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 |
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) Location | Badalona, 8916, Spain |
Recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica | Bologna, 40138, Italy |
Recruiting | Hospital Quiron Dexeus - Oncologia | Barcelona, 08028, Spain |
Recruiting | Hospital Universitario De Navarra - Oncologia | Pamplona, 31008, Spain |
Recruiting | Hospital Universitario Y Politecnico La Fe - Oncologia | Valencia, 46026, Spain |
Recruiting | Complejo Hospitalario Universitario A Coruna (CHUAC) | A Coruna, 15006, Spain |
Recruiting | Fundacion Instituto Valenciano de Oncologia (IVO | Valencia, 46009, Spain |
Recruiting | Niigata Cancer Center Hospital | Niigata, 951-8566, Japan |
Recruiting | Nippon Medical School - Nippon Medical School Hospital - Cancer Center | Bunkyo-ku, 113-8603, Japan |
Withdrawn | Regionshospitalet Gødstrup - Medicinsk afdeling | Herning, 7400, Denmark |
Recruiting | Rigshospitalet - Kræftbehandling | Copenhagen OE, 2100, Denmark |
Recruiting | Istituto Oncologico Veneto_Padova - UOC Oncologia 2 | Padova, 35128, Italy |
Recruiting | Beijing Cancer Hospital - Oncology Department | Beijing, 100142, China |
Recruiting | Beijing Hospital | Beijing, 100730, China |
Recruiting | Shandong University - Shandong Cancer Hospital | Jinan, 250117, China |
Recruiting | Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku | Otwock, 05-400, Poland |
Recruiting | National Hospital Organization Nagoya Medical Center | Nagoya, 460-0001, Japan |
Recruiting | Kitasato University Hospital | Sagamihara, 252-0375, Japan |
Recruiting | Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde | Salzburg, 5020, Austria |
Recruiting | UM Greenebaum Comprehensive Cancer Center | Baltimore, 21201, United States |
Recruiting | Torbay Hospital | Torquay, TQ2 7AA, United Kingdom |
Withdrawn | Centro Médico Privado CEMAIC | Córdoba, X5008HHW, Argentina |
Recruiting | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Withdrawn | 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 |
Recruiting | University General Hospital ATTIKON, Department of Internal Medicine IV | Chaidari, 12462, Greece |
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 |
Recruiting | Hospital Universitario Fundacion Jimenez Diaz- Oncology Service | Madrid, 28040, Spain |
Recruiting | Hospital General Universitario Gregorio Maranon | Oncologia | Madrid, 28009, Spain |
Recruiting | Hospital Universitario Puerta De Hierro De Majadahonda - Oncologia | Majadahonda, 28222, Spain |
Recruiting | University General Hospital of Athens "ATTIKON" | Chaidari, 12462, Greece |
Recruiting | Bioclinic Thessaloniki | Thessaloniki, 54622, Greece |
Recruiting | PAPANIKOLAOU General Hospital of Thessaloniki | Thessaloniki, 57010, Greece |
Recruiting | University General Hospital of Larissa | Larissa, 41110, Greece |
Recruiting | General Hospital of Athens “Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA | Athens, 11528, Greece |
Recruiting | University of Athens Medical School-Sotiria General Hospital - 3rd Dept of Medicine & Medical Oncology | Athens, 11527, Greece |
Recruiting | Raffles Cancer Centre | Singapore, 188770, Singapore |
Recruiting | Odense University Hospital - Oncology Department | Odense C, 5000, Denmark |
Recruiting | Chi-Mei Medical Center, Liouyine | Tainan, 73657, Taiwan |
Recruiting | Chung Shan Medical University Hospital | Taichung, 402306, Taiwan |
Recruiting | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Recruiting | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Recruiting | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City, 807377, Taiwan |
Recruiting | Aalborg University hospital - oncology department | Aalborg, 9000, Denmark |
Recruiting | Aarhus Universitetshospital | Aarhus N, 8200, Denmark |
Recruiting | Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik | Wien, 1210, Austria |
Recruiting | Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie | Wien, 1090, Austria |
Recruiting | Profound Research - OMG - Royal Oak Cancer Center | Royal Oak, 48073, United States |
Recruiting | Profound Research -OMG - TriAtria Cancer Center | Farmington Hills, 48334, United States |
Recruiting | Assuta Ashdod Public Hospital (R.A) | Ashdod, 7747629, Israel |
Not yet recruiting | Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin | Hemer, 58675, Germany |
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 |
Recruiting | Providence Cancer Institute - Franz Clinic | Portland, 97213, United States |
Recruiting | Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III | Salzburg, 5020, Austria |
Recruiting | Royal Surrey County Hospital | Guildford, GU2 7XX, United Kingdom |
Recruiting | The University of Chicago Medical Center - Hyde Park - Hematology & Oncology | Chicago, 60637, United States |
Recruiting | hopital cochin APHP - service de pneumologie | Paris, 75014, France |
Recruiting | Instituto Nacional de Cancerología | Mexico, 14080, Mexico |
Recruiting | Oncare Viaducto Nápoles | CDMX, 3810, Mexico |
Recruiting | Oncología Integral Satélite | Naucalpan, 53100, Mexico |
Recruiting | Skåne University Hospital | Lund, 221 85, Sweden |
Recruiting | MHAT "Heart and brain" Pleven | Pleven, 5804, Bulgaria |
Recruiting | MHAT Serdika | Sofia, 1632, Bulgaria |
Recruiting | University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia | Sofia, 1797, Bulgaria |
Recruiting | MHAT Uni Hospital | Panagyurishte, 4500, Bulgaria |
Not yet recruiting | Specialized Hospital for Active Treatment of Oncology | Sofia, 1797, Bulgaria |
Recruiting | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Recruiting | Multiprofile Hospital for Active Treatment "Sveta Sofia" | Sofia, 1404, Bulgaria |
Not yet recruiting | MHAT Park Hospital EOOD | Plovdiv, 4109, Bulgaria |
Recruiting | Complex Oncology Center - Plovdiv EOOD | Plovdiv, 4004, Bulgaria |
Not yet recruiting | Metropolitan Hospital- 4th Oncology Clinic | Piraeus, 18547, Greece |
Recruiting | Docrates Mehiläinen Syöpäsairaala | Helsinki, FIN-00180, Finland |
Recruiting | Turun yliopistollinen keskussairaala | Turku, 20520, Finland |
Recruiting | Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi | Lodz, 92-213, Poland |
Recruiting | Swietokrzyskie Centrum Onkologii | Kielce, 25-734, Poland |
Recruiting | Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Poznan, 60-569, Poland |
Not yet recruiting | Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw, 53-413, Poland |
Recruiting | Norrland University Hospital - Cancercentrum | Umeå, 90185, Sweden |
Not yet recruiting | Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi | Kadikoy, 34722, Turkey |
Recruiting | Adana Sehir Egitim ve Arastirma Hastanesi | Yuregir, 1370, Turkey |
Not yet recruiting | Ankara Bilkent Sehir Hastanesi | Bilkent ankara, 6800, Turkey |
Recruiting | Ankara Etlik Sehir Hastanesi | Yenimahalle, 6170, Turkey |
Recruiting | I.A.Ü. VM Medical Park Florya Hastanesi | Kucukcekmece, 34295, Turkey |
Recruiting | Marmara University Hospital | Istanbul, 34899, Turkey |
Recruiting | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Recruiting | Sakarya Universitesi Egitim ve Arastirma Hastanesi | Sakarya, 54100, Turkey |
Recruiting | Radiotherapy Center Cluj SRL | Flore?ti, 407280, Romania |
Withdrawn | UMass Memorial Medical Center - University Campus - Oncology | Worcester, 01655-0002, United States |
Recruiting | Centrul de Oncologie Sfantul Nectarie | Craiova, 200745, Romania |
Recruiting | Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II | Bucuresti, 22328, Romania |
Recruiting | Blacktown Cancer & Haematology Centre | Blacktown, 2148, Australia |
Recruiting | SC ONCOLAB SRL | Craiova, 200385, Romania |
Recruiting | UCLA Health Santa Monica Cancer Care | Santa Monica, 90404, United States |
Withdrawn | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, 15-276, Poland |
Withdrawn | Centro de Investigaciones Clínicas, Clínica Viedma | Viedma, R8500, Argentina |
Recruiting | Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály | Budapest, 1145, Hungary |
Withdrawn | Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabanya, 2800, Hungary |
Recruiting | Fakultna nemocnica Trnava | Trnava, 91775, Slovakia |
Recruiting | POKO Poprad s.r.o. | Poprad, 058 01, Slovakia |
Recruiting | Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province | Taizhou, 317000, China |
Recruiting | Prince of Wales Hospital | Hong Kong, MISSING, Hong Kong |
Recruiting | Queen Mary Hospital | Hong Kong, MISSING, Hong Kong |
Recruiting | Hong Kong United Oncology Centre | Kowloon, Hong Kong |
Recruiting | Spitalul Clinic Coltea | Bucuresti, 30171, Romania |
Withdrawn | Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy | Olomouc, 77900, Czech Republic |
Recruiting | Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie | Zlin, 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 onkologie | Nový Jicín, 741 01, Czech Republic |
Recruiting | Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddelení | Ostrava - Vítkovice, 703 00, Czech Republic |
Recruiting | Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department | Hangzhou, 310016, China |
Recruiting | West China Hospital Sichuan University | Chengdu, 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 Center | New Hyde Park, 11042, 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 |
Recruiting | Zhongshan Hospital, Fudan University - Oncology Department | Shanghai, 200032, China |
Recruiting | Queen Elizabeth Hospital Hong Kong | Hong Kong, NA, Hong Kong |
Recruiting | Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia | Nuevo León, 64460, Mexico |
Recruiting | Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit | Concord, 2139, Australia |
Recruiting | Austin Hospital - Olivia Newton John Cancer Research Institute | Heidelberg, 3084, Australia |
Recruiting | University of the Sunshine Coast | Buderim, 4556, Australia |
Recruiting | MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department | Uzhhorod, 88000, Ukraine |
Recruiting | LLC "RDP Ukraine" - Medical Department | Dnipro, 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 #1 | Kyiv, 03115, Ukraine |
Recruiting | Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center | Kropyvnytskyi, 25006, Ukraine |
Recruiting | Medical Center LLC "Verum Expert Clinic" | Kyiv, 3039, Ukraine |
Recruiting | Volyn Regional Oncology Center | Lutsk, 43018, Ukraine |
Recruiting | Limited Liability Company "MedOffice Group Medical Center" | Kyiv, 03189, Ukraine |
Recruiting | Fujian Cancer Hospital | Fuzhou, 350014, China |
Not yet recruiting | Hunan Cancer Hospital - Oncology Department | Changsha, 410013, China |
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 |
Recruiting | The People's Liberation Army General Hospital (Beijing 301 Hospital) | Beijing, 100853, China |
Recruiting | Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech | Wuhan, 430023, China |
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 |
Recruiting | Guangzhou Medical University - The First Affiliated Hospital | Guangzhou, 510230, China |
Recruiting | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Recruiting | Beacon Hospital | Petaling Jaya, 46050, Malaysia |
Recruiting | Sunway Medical Centre | Subang Jaya, 47500, Malaysia |
Recruiting | Sunway Medical Centre Penang | Perai, 13700, Malaysia |
Recruiting | University Malaya Medical Centre | Kuala Lumpur, 59100, Malaysia |
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 |
Recruiting | UC San Diego Health - Moores Cancer Center | San Diego, 92037, United States |
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 - Texas Medical Center | Houston, 77030, United States |
Recruiting | Columbia Asia Hospital Bukit Rimau | Shah Alam, 40460, Malaysia |
Not yet recruiting | University Hospital Kebangsaan Malaysia | Cheras, 56000, Malaysia |
Recruiting | UC Medical Center - Oncology | Cincinnati, 45219, United States |
Withdrawn | UT Southwestern | Dallas, 75235, United States |
Recruiting | UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology | San Francisco, 94158, United States |
Recruiting | University of Minnesota Medical Center | Minneapolis, 55455, United States |
Recruiting | Hospital Universitario Ramon Y Cajal - Oncologia | Madrid, 28034, Spain |
Not yet recruiting | Careggi University Hospital - Oncologia Clinica | Firenze, 50134, Italy |
Recruiting | Ospedale San Raffaele s.r.l. - Oncologia Medica | Milano, 20132, Italy |
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 |
Recruiting | Ospedale Vito Fazzi Lecce - Oncologia | Lecce, 73100, Italy |
Not yet recruiting | Brampton Civic Hospital - Oncology | Brampton, L6R 3J7, Canada |
Recruiting | Careggi University Hospital - Oncologia Clinica | Firenze, 50134, Italy |
Recruiting | Oncocenter | Timisoara, 300166, Romania |
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 |
Recruiting | HFR Freiburg – Kantonsspital | Fribourg, 1708, Switzerland |
Recruiting | University of Illinois Hospital - Outpatient Cancer Care Center | Chicago, 60612, United States |
Recruiting | AdventHealth Cancer Institute | Orlando, 32804, United States |
Withdrawn | 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 |
Not yet recruiting | Moffitt Cancer Center - Magnolia Campus | 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 | Unidade Local Saúde Coimbra, E.P.E | Coimbra, 3004-561, Portugal |
Not yet recruiting | Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials Unit | Cardiff, CF14 2TL, United Kingdom |
Recruiting | Allegheny General Hospital | Pittsburgh, 15212, United States |
Not yet recruiting | Hopital Nord Laennec - Oncologie medicale thoracique et digestive | Nantes, 44093, France |
Not yet recruiting | Centre Antoine Lacassagne - Departement Oncologie | Nice, 06100, France |
Not yet recruiting | Piedmont Cancer Institute - Atlanta | Atlanta, 30318, United States |
Suspended | Virginia Commonwealth University | Richmond, 23298, United States |
Not yet recruiting | John B. Amos Cancer Center | Columbus, 31904, United States |
Not yet recruiting | ?enry Durant Hospital Center-4th Oncology Department and Clinical Trials Unit | Athens, 115 26, Greece |
Not yet recruiting | Gleneagles Penang Medical Center | George Town,, 10050, Malaysia |
Not yet recruiting | Providence Oncology and Hematology Care Clinic Westside | Portland, 97225, 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) per RECIST 1.1 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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