Mark Socinski, MD Principal Investigator Advent Health System Tianhong Li, MD, PhD Principal Investigator University of California, Davis Kai He, MD, PhD Principal Investigator Ohio State University
Städt. Klinikum München GmbH - 2204 81925 Bogenhausen (Bayern) GermanyNoch nicht rekrutierend» Google-MapsKliniken Essen-Mitte - 2206 45136 Essen (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-MapsKlinikum Esslingen GmbH - 2201 73730 Esslingen am Neckar (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-Maps
Lungenfachklinik Immenhausen - 2202 34376 Immenhausen (Hessen) GermanyNoch nicht rekrutierend» Google-MapsKlinikverbund Allgaü - Klinikum Kempten - 2205 87509 Immenstädt (Bayern) GermanyNoch nicht rekrutierend» Google-MapsAsklepios Fachkliniken Muenchen-Gauting - 2203 82131 Muenchen-Gauting (Bayern) GermanyNoch nicht rekrutierend» Google-MapsXCancer/Dothan Hematology & Oncology - 1114 36303 Dothan United StatesRekrutierend» Google-MapsGenesis Cancer and Blood Institute - 1123 72801 Russellville United StatesNoch nicht rekrutierend» Google-MapsThe Oncology Institute (TOI) Clinical Research - 1109 90703 Cerritos United StatesRekrutierend» Google-MapsSharp Healthcare - 1150 91911 Chula Vista United StatesNoch nicht rekrutierend» Google-MapsEmad Ibrahim MD Inc. - 1147 92373 Redlands United StatesNoch nicht rekrutierend» Google-MapsUC Davis Comprehensive Cancer Center - 1103 95817 Sacramento United StatesRekrutierend» Google-MapsBass Medical Group - 1155 94598 Walnut Creek United StatesNoch nicht rekrutierend» Google-MapsUniversity of Connecticut - 1111 06030 Farmington United StatesNoch nicht rekrutierend» Google-MapsNuvance Health - 1118 06850 Norwalk United StatesRekrutierend» Google-MapsD&H Cancer Research Center LLC - 1153 33063 Margate United StatesNoch nicht rekrutierend» Google-MapsOcala Oncology Center PL - 1102 34474 Ocala United StatesRekrutierend» Google-MapsAdventHealth Cancer Institute - 1105 32804 Orlando United StatesRekrutierend» Google-MapsOrlando Health - 1130 32806 Orlando United StatesRekrutierend» Google-MapsFlorida Cancer Specialists -South - 1126 34232 Sarasota United StatesNoch nicht rekrutierend» Google-MapsFlorida Cancer Specialists -North - 1125 32159 The Villages United StatesNoch nicht rekrutierend» Google-MapsFlorida Cancer Specialists -East - 1124 33401 West Palm Beach United StatesNoch nicht rekrutierend» Google-MapsOrchard Healthcare Research, Inc. - 1116 60077 Skokie United StatesRekrutierend» Google-MapsSpringfield Clinic - The Cancer Center - 1110 62702 Springfield United StatesRekrutierend» Google-MapsFort Wayne Medical Oncology - 1133 46805 Fort Wayne United StatesRekrutierend» Google-MapsDeaconess Chancellor Center for Oncology - 1131 47630 Newburgh United StatesNoch nicht rekrutierend» Google-MapsAlliance for Multispecialty Research, LLC - 1144 66204 Merriam United StatesRekrutierend» Google-MapsCotton O'Neil Clinical Research Center - 1151 66606 Topeka United StatesNoch nicht rekrutierend» Google-MapsUniversity of Kentucky - Markey Cancer Center - 1112 40536 Lexington United StatesRekrutierend» Google-MapsNorton Cancer Institute - 1108 40202 Louisville United StatesRekrutierend» Google-MapsHematology Oncology Clinics - Baton Rouge - 1142 70809 Baton Rouge United StatesRekrutierend» Google-MapsHealthPartners Institute, Cancer Research Center - 1143 55426 Saint Louis Park United StatesNoch nicht rekrutierend» Google-MapsJefferson City Medical Group - 1145 65109 Jefferson City United StatesRekrutierend» Google-MapsNHO-Revive Research Institute, LLC - 1152 68506 Lincoln United StatesNoch nicht rekrutierend» Google-MapsAstera Cancer Care - 1128 08816 East Brunswick United StatesRekrutierend» Google-MapsMessino Cancer Centers - 1121 28806 Asheville United StatesNoch nicht rekrutierend» Google-MapsUniversity of Cincinnati Cancer Center - 1107 45219 Cincinnati United StatesRekrutierend» Google-MapsThe Ohio State University James Cancer Center - 1104 43210 Columbus United StatesRekrutierend» Google-MapsMiami Valley Hospital - 1115 45409 Dayton United StatesRekrutierend» Google-MapsTri County Hematology & Oncology Associates, Inc - 1156 44646 Massillon United StatesNoch nicht rekrutierend» Google-MapsOklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) - 1154 74146 Tulsa United StatesNoch nicht rekrutierend» Google-MapsOncology Associates of Oregon - 1138 97401 Eugene United StatesNoch nicht rekrutierend» Google-MapsPennsylvania Cancer Specialists Research Institute - 1101 17325 Gettysburg United StatesRekrutierend» Google-MapsDonald Guthrie Foundation - 1135 18840 Sayre United StatesRekrutierend» Google-MapsCancer Care Associates of York, Inc. - 1113 17403 York United StatesRekrutierend» Google-MapsUniversity of Tennessee Medical Center - 1146 37920 Knoxville United StatesRekrutierend» Google-MapsSarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119 37203 Nashville United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology -Dallas - 1127 75230 Dallas United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology - Denison - 1139 75020 Denison United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology - Fort Worth Cancer Center - 1141 76105 Fort Worth United StatesNoch nicht rekrutierend» Google-MapsOncology Consultants, P.A. - 1120 77024 Houston United StatesRekrutierend» Google-MapsTexas Oncology - McAllen - 1132 78503 McAllen United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology - Plano West - 1137 75093 Plano United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology -San Antonio - 1122 78240 San Antonio United StatesNoch nicht rekrutierend» Google-MapsTexas Oncology - Northeast Texas - Tyler - 1134 75702 Tyler United StatesNoch nicht rekrutierend» Google-MapsNEXT Oncology - Virginia - 1129 22031 Fairfax United StatesNoch nicht rekrutierend» Google-MapsVirginia Cancer Institute - 1149 23226 Henrico United StatesRekrutierend» Google-MapsVirginia Oncology Associates - 1136 23502 Norfolk United StatesNoch nicht rekrutierend» Google-MapsMultiCare Institute for Research and Innovation - Tacoma - 1148 99218 Spokane United StatesNoch nicht rekrutierend» Google-MapsBankstown Hospital - 3305 2200 Bankstown AustraliaRekrutierend» Google-MapsNewcastle Private Hospital - 3302 New Lambton Heights AustraliaRekrutierend» Google-MapsMater - 3301 4006 Newstead AustraliaRekrutierend» Google-MapsCancer Research SA - 3303 5000 Adelaide AustraliaRekrutierend» Google-MapsAZ Maria Middelares - 2104 9000 Gent BelgiumNoch nicht rekrutierend» Google-MapsJessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102 3500 Hasselt BelgiumNoch nicht rekrutierend» Google-MapsC. H. R. de la Citadelle - 2103 4000 Liège BelgiumNoch nicht rekrutierend» Google-MapsVitaz - Sint-niklaas Moerland - 2101 9100 Sint-Niklaas BelgiumNoch nicht rekrutierend» Google-MapsBC Cancer Centre - Kelowna - 1203 Kelowna CanadaNoch nicht rekrutierend» Google-MapsSaskatchewan Cancer Agency - Regina - 1201 S4T 7T1 Regina CanadaNoch nicht rekrutierend» Google-MapsSaskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202 S7N 4H4 Saskatoon CanadaNoch nicht rekrutierend» Google-MapsSanta Cabrini Hospital - 1204 H1T1P7 Québec CanadaNoch nicht rekrutierend» Google-MapsThe First Affiliated Hospital of Anhui Medical University - 3221 230022 Hefei ChinaNoch nicht rekrutierend» Google-MapsAnhui Medical University - The Second Hospital - 3222 231200 Hefei ChinaNoch nicht rekrutierend» Google-MapsBeijing Cancer Hospital - 3205 Beijing ChinaNoch nicht rekrutierend» Google-MapsCancer Hospital, Chinese Academy of Medical Sciences - 3211 Beijing ChinaNoch nicht rekrutierend» Google-MapsFujian Medical University Union Hospital - 3225 Fuzhou ChinaNoch nicht rekrutierend» Google-MapsThe First Affiliated Hospital of Xiamen University - 3210 Xiamen ChinaNoch nicht rekrutierend» Google-MapsDongguan People's Hospital - 3206 Dongguan ChinaRekrutierend» Google-MapsGuangdong Provincial People's Hospital - 3201 510105 Guangzhou ChinaRekrutierend» Google-MapsZhujiang Hospital of Southern Medical University - 3203 510280 Guangzhou ChinaNoch nicht rekrutierend» Google-MapsThe First Affiliated Hospital of Guangdong Pharmaceutical University - 3215 Guangzhou ChinaRekrutierend» Google-MapsThe People's Hospital of Guangxi Zhuang Autonomous Region - 3228 530021 Nanning ChinaNoch nicht rekrutierend» Google-MapsHainan General Hospital - 3202 Haikou ChinaNoch nicht rekrutierend» Google-MapsAffiliated Hospital of Hebei University - 3214 71000 Zhengzhou ChinaRekrutierend» Google-MapsThe Affiliated Tumor Hospital of Harbin Medical University - 3232 150040 Harbin ChinaNoch nicht rekrutierend» Google-MapsHenan Cancer Hospital - 3226 450008 Zhengzhou ChinaNoch nicht rekrutierend» Google-MapsThe First Affliated Hospital of Zhengzhou University - 3207 Zhengzhou ChinaNoch nicht rekrutierend» Google-MapsRenmin Hospital of Wuhan University - 3216 Wuhan ChinaRekrutierend» Google-MapsUnion Hospital Tongji Medical College - 3212 Wuhan ChinaNoch nicht rekrutierend» Google-MapsXiangya Hospital, Central South University - 3223 410008 Changsha ChinaNoch nicht rekrutierend» Google-MapsHunan Cancer Hospital - 3209 Changsha ChinaNoch nicht rekrutierend» Google-MapsThe Second Affiliated Hospital of Soochow University - 3217 Suzhou ChinaNoch nicht rekrutierend» Google-MapsXuzhou Medical University - The Affiliated Hospital - 3234 221002 Xuzhou ChinaNoch nicht rekrutierend» Google-MapsThe Second Affiliated Hospital of Nanchang University - 3224 330006 Nanchang ChinaRekrutierend» Google-MapsJinan Central Hospital - 3230 250013 Jinan ChinaRekrutierend» Google-MapsShanxi Bethune Hospital - 3233 30032 Taiyuan ChinaNoch nicht rekrutierend» Google-MapsThe First Affiliated Hospital of Xi'an Jiaotong University - 3218 Xi'an ChinaNoch nicht rekrutierend» Google-MapsChengdu Seventh People's Hospital - 3229 610041 Chengdu ChinaNoch nicht rekrutierend» Google-MapsSichuan Cancer Hospital - 3227 610041 Chengdu ChinaNoch nicht rekrutierend» Google-MapsChongqing University Cancer Hospital - 3213 Chongqing ChinaNoch nicht rekrutierend» Google-MapsTianjin Medical University Cancer Institute and Hospital - 3208 Tianjin ChinaNoch nicht rekrutierend» Google-MapsYunnan Cancer Hospital - 3231 650118 Kunming ChinaNoch nicht rekrutierend» Google-MapsSir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219 Hangzhou ChinaNoch nicht rekrutierend» Google-MapsThe Second Affiliated Hospital of Zhejiang University School of Medicine - 3220 Hangzhou ChinaNoch nicht rekrutierend» Google-MapsZhejiang Cancer Hospital - 3204 Hangzhou ChinaNoch nicht rekrutierend» Google-MapsChina-Japan Friendship Hospital - 3236 100029 Beijing ChinaNoch nicht rekrutierend» Google-MapsWest China Hospital, Sichuan University - 3238 610041 Chengdu ChinaNoch nicht rekrutierend» Google-MapsNanjing Medical University (NMU) - Nanjing First Hospital - 3239 21006 Jiangse ChinaNoch nicht rekrutierend» Google-MapsWeifang Second People's Hospital - 3235 261041 Shandong ChinaNoch nicht rekrutierend» Google-MapsTongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240 200120 Shanghai ChinaNoch nicht rekrutierend» Google-MapsHubei Cancer Hospital - 3237 430079 Wuhan ChinaNoch nicht rekrutierend» Google-MapsHôpital Ambroise Paré - 2501 92100 Billancourt FranceNoch nicht rekrutierend» Google-MapsCentre Hospitalier Intercommunal de Créteil - 2502 94000 Créteil FranceNoch nicht rekrutierend» Google-MapsCHU Limoges - Hospital du Cluzeau - 2503 Limoges FranceNoch nicht rekrutierend» Google-MapsClinica Oncologica Ospedali Riuniti Ancona - 2311 60126 Ancona ItalyNoch nicht rekrutierend» Google-MapsIRCCS Istituto Tumori Giovanni Paolo II - 2306 70124 Bari ItalyNoch nicht rekrutierend» Google-MapsAzienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310 24126 Bergamo ItalyNoch nicht rekrutierend» Google-MapsAzienda Ospedaliera Papardo - 2301 98158 Messina ItalyNoch nicht rekrutierend» Google-MapsOspedale San Raffaele - 2307 20132 Milano ItalyNoch nicht rekrutierend» Google-MapsFondazione IRCCS Instituto Tumori Di Milano - 2305 20133 Milano ItalyNoch nicht rekrutierend» Google-MapsOspedale San Gerardo di Monza - 2302 20900 Monza ItalyNoch nicht rekrutierend» Google-MapsAzienda Ospedaliera Universitaria "Federico II" - 2304 80131 Naples ItalyNoch nicht rekrutierend» Google-MapsAOU Policlinico Giaccone, Università di Palermo - 2309 90129 Palermo ItalyNoch nicht rekrutierend» Google-MapsUniversita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308 06132 Perugia ItalyNoch nicht rekrutierend» Google-MapsUniversita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303 00128 Roma ItalyNoch nicht rekrutierend» Google-MapsChungbuk National University Hospital - 3101 28644 Cheongju-si Korea, Republic ofNoch nicht rekrutierend» Google-MapsKeimyung University Dongsan Hospital - 3102 42601 Daegu Korea, Republic ofNoch nicht rekrutierend» Google-MapsNational Cancer Center - 3107 10408 Goyang-si Korea, Republic ofNoch nicht rekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System - 3104 03722 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsAsan Medical Centre - 3103 05505 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsKorea University Guro Hospital - 3106 08308 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsThe Catholic University of Korea, St Vincent's Hospital - 3105 16247 Suwon Korea, Republic ofNoch nicht rekrutierend» Google-MapsAntoni van Leeuwenhoek - 2703 1066 CV Amsterdam NetherlandsNoch nicht rekrutierend» Google-MapsRijnstate Ziekenhuis - 2701 6815 Arnhem NetherlandsNoch nicht rekrutierend» Google-MapsJeroen Bosch Ziekenhuis - 2702 5223 Herzogenbusch NetherlandsNoch nicht rekrutierend» Google-MapsETZ Elisabeth - 2704 5022 GC Tilburg NetherlandsNoch nicht rekrutierend» Google-MapsHospital General Universitario de Elche - 2401 03203 Elche SpainNoch nicht rekrutierend» Google-MapsHospital Universitario Lucus Augusti - 2405 27003 Lugo SpainNoch nicht rekrutierend» Google-MapsHospital General Universitario Gregorio Marañon - 2404 28007 Madrid SpainNoch nicht rekrutierend» Google-MapsHospital Regional Universitario de Malaga - 2403 29010 Málaga SpainNoch nicht rekrutierend» Google-MapsHospital General Universitario de Valencia - 2406 46014 Valencia SpainNoch nicht rekrutierend» Google-MapsFundacion Instituto Valenciano De Oncologia (IVO) - 2402 56009 Valencia SpainNoch nicht rekrutierend» Google-MapsAdana Sehir Hastanesi - 2602 Adana TurkeyNoch nicht rekrutierend» Google-MapsBaskent University Adana - 2601 Adana TurkeyNoch nicht rekrutierend» Google-MapsHacettepe Universitesi - 2609 06230 Ankara TurkeyNoch nicht rekrutierend» Google-MapsAnkara Bilkent Sehir Hastanesi - 2610 06800 Ankara TurkeyNoch nicht rekrutierend» Google-MapsAkdeniz University Medical Hospital - 2606 Antalya TurkeyNoch nicht rekrutierend» Google-MapsEge Universitesi Hastanesi - 2612 35100 Bornova TurkeyNoch nicht rekrutierend» Google-MapsTrakya University Faculty of Medicine Edirne - 2608 Edirne TurkeyNoch nicht rekrutierend» Google-MapsIstanbul Üniversitesi Onkoloji Enstitüsü - 2613 34093 Fatih TurkeyNoch nicht rekrutierend» Google-MapsKoc Universitesi - 2611 34010 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsGöztepe Prof Dr. Suleyman Yalcin City Hospital - 2605 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsIstanbul Bakirkoy Sadi Konuk - 2604 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsMedipol University Medical Faculty Hospital - 2603 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsIzmir Ekonomi Universitesi Medical Point Hastanesi - 2607 İzmir TurkeyNoch nicht rekrutierend» Google-MapsUniversity Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801 B15 2TG Birmingham United KingdomNoch nicht rekrutierend» Google-MapsCambridge University Hospitals - 2804 CB2 0QQ Cambridge United KingdomNoch nicht rekrutierend» Google-MapsRoyal Devon University Healthcare NHS - 2808 EX25DW Exeter United KingdomNoch nicht rekrutierend» Google-MapsUniversity Hospital Leicester - 2806 LE1 5WW Leicester United KingdomNoch nicht rekrutierend» Google-MapsThe Christie NHS Foundation Trust - 2803 EC1A 7BE London United KingdomNoch nicht rekrutierend» Google-MapsBarts Health NHS Trust (St. Bartholomew's Hospital) - 2802 M20 4BX Manchester United KingdomNoch nicht rekrutierend» Google-MapsSouth Tees Hospitals - 2807 TS4 3BW Middlesbrough United KingdomNoch nicht rekrutierend» Google-MapsUniversity Hospital Southampton - 2810 SO16 6YD Southampton United KingdomNoch nicht rekrutierend» Google-MapsTorbay Hospital - Horizon Centre - 2805 TQ2 7AA Torquay United KingdomNoch nicht rekrutierend» Google-MapsEdinburgh Cancer Centre - 2809 EH4 2XU Edinburgh United KingdomNoch nicht rekrutierend» Google-Maps
1. Overall Survival (OS) (Time Frame - 36 months): OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
Secondary outcome:
1. Objective response rate (ORR) (Time Frame - 36 months): Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
2. Progression-free survival (PFS) (Time Frame - 36 months): Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1
3. Treatment emergent adverse events, treatment related adverse events and immune related adverse events. (Time Frame - 36 months): Incidence of TEAEs, TRAEs, irAEs will be calcuated. The AEs leading to treatment discontinuation will be recorded.
Experimental: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Experimental: Arm 2: Gotistobart 3 mg/kg Q3W Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Active Comparator: Arm 3: Docetaxel 75 mg/m2, Q3W Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Gotistobart (A humanized anti-CTLA4 IgG1 monoclonal antibody / ONC-392 / BNT316 / ): Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
Docetaxel (Docefrez / Taxotere / ): Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors"
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