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ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

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研究单位: [1]OncoC4, Inc. [2]Advent Health System [3]University of California, Davis [4]Ohio State University [5]BioNTech SE [6]XCancer/Dothan Hematology & Oncology - 1114,Dothan,Alabama,United States,36303 [7]Genesis Cancer and Blood Institute - 1123,Russellville,Arkansas,United States,72801 [8]The Oncology Institute (TOI) Clinical Research - 1109,Cerritos,California,United States,90703 [9]Sharp Healthcare - 1150,Chula Vista,California,United States,91911 [10]Emad Ibrahim MD Inc. - 1147,Redlands,California,United States,92373 [11]UC Davis Comprehensive Cancer Center - 1103,Sacramento,California,United States,95817 [12]Bass Medical Group - 1155,Walnut Creek,California,United States,94598 [13]University of Connecticut - 1111,Farmington,Connecticut,United States,06030 [14]Nuvance Health - 1118,Norwalk,Connecticut,United States,06850 [15]D&H Cancer Research Center LLC - 1153,Margate,Florida,United States,33063 [16]Ocala Oncology Center PL - 1102,Ocala,Florida,United States,34474 [17]AdventHealth Cancer Institute - 1105,Orlando,Florida,United States,32804 [18]Orlando Health - 1130,Orlando,Florida,United States,32806 [19]Florida Cancer Specialists -South - 1126,Sarasota,Florida,United States,34232 [20]Florida Cancer Specialists -North - 1125,The Villages,Florida,United States,32159 [21]Florida Cancer Specialists -East - 1124,West Palm Beach,Florida,United States,33401 [22]Orchard Healthcare Research, Inc. - 1116,Skokie,Illinois,United States,60077 [23]Springfield Clinic - The Cancer Center - 1110,Springfield,Illinois,United States,62702 [24]Fort Wayne Medical Oncology - 1133,Fort Wayne,Indiana,United States,46805 [25]Deaconess Chancellor Center for Oncology - 1131,Newburgh,Indiana,United States,47630 [26]Alliance for Multispecialty Research, LLC - 1144,Merriam,Kansas,United States,66204 [27]Cotton O''Neil Clinical Research Center - 1151,Topeka,Kansas,United States,66606 [28]University of Kentucky - Markey Cancer Center - 1112,Lexington,Kentucky,United States,40536 [29]Norton Cancer Institute - 1108,Louisville,Kentucky,United States,40202 [30]Hematology Oncology Clinics - Baton Rouge - 1142,Baton Rouge,Louisiana,United States,70809 [31]HealthPartners Institute, Cancer Research Center - 1143,Saint Louis Park,Minnesota,United States,55426 [32]Jefferson City Medical Group - 1145,Jefferson City,Missouri,United States,65109 [33]NHO-Revive Research Institute, LLC - 1152,Lincoln,Nebraska,United States,68506 [34]Astera Cancer Care - 1128,East Brunswick,New Jersey,United States,08816 [35]Messino Cancer Centers - 1121,Asheville,North Carolina,United States,28806 [36]University of Cincinnati Cancer Center - 1107,Cincinnati,Ohio,United States,45219 [37]The Ohio State University James Cancer Center - 1104,Columbus,Ohio,United States,43210 [38]Miami Valley Hospital - 1115,Dayton,Ohio,United States,45409 [39]Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) - 1154,Tulsa,Oklahoma,United States,74146 [40]Oncology Associates of Oregon - 1138,Eugene,Oregon,United States,97401 [41]Pennsylvania Cancer Specialists Research Institute - 1101,Gettysburg,Pennsylvania,United States,17325 [42]Donald Guthrie Foundation - 1135,Sayre,Pennsylvania,United States,18840 [43]Cancer Care Associates of York, Inc. - 1113,York,Pennsylvania,United States,17403 [44]University of Tennessee Medical Center - 1146,Knoxville,Tennessee,United States,37920 [45]Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119,Nashville,Tennessee,United States,37203 [46]Texas Oncology -Dallas - 1127,Dallas,Texas,United States,75230 [47]Texas Oncology - Denison - 1139,Denison,Texas,United States,75020 [48]Texas Oncology - Fort Worth Cancer Center - 1141,Fort Worth,Texas,United States,76105 [49]Oncology Consultants, P.A. - 1120,Houston,Texas,United States,77024 [50]Texas Oncology - McAllen - 1132,McAllen,Texas,United States,78503 [51]Texas Oncology - Plano West - 1137,Plano,Texas,United States,75093 [52]Texas Oncology -San Antonio - 1122,San Antonio,Texas,United States,78240 [53]Texas Oncology - Northeast Texas - Tyler - 1134,Tyler,Texas,United States,75702 [54]NEXT Oncology - Virginia - 1129,Fairfax,Virginia,United States,22031 [55]Virginia Cancer Institute - 1149,Henrico,Virginia,United States,23226 [56]Virginia Oncology Associates - 1136,Norfolk,Virginia,United States,23502 [57]MultiCare Institute for Research and Innovation - Tacoma - 1148,Spokane,Washington,United States,99218 [58]Bankstown Hospital - 3305,Bankstown,New South Wales,Australia,2200 [59]Newcastle Private Hospital - 3302,New Lambton Heights,New South Wales,Australia [60]Mater - 3301,Newstead,Queensland,Australia,4006 [61]Cancer Research SA - 3303,Adelaide,South Australia,Australia,5000 [62]AZ Maria Middelares - 2104,Gent,Belgium,9000 [63]Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102,Hasselt,Belgium,3500 [64]C. H. R. de la Citadelle - 2103,Liège,Belgium,4000 [65]Vitaz - Sint-niklaas Moerland - 2101,Sint-Niklaas,Belgium,9100 [66]BC Cancer Centre - Kelowna - 1203,Kelowna,British Columbia,Canada [67]Saskatchewan Cancer Agency - Regina - 1201,Regina,Saskatchewan,Canada,S4T 7T1 [68]Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202,Saskatoon,Saskatchewan,Canada,S7N 4H4 [69]Santa Cabrini Hospital - 1204,Québec,Canada,H1T1P7 [70]The First Affiliated Hospital of Anhui Medical University - 3221,Hefei,Anhui,China,230022 [71]Anhui Medical University - The Second Hospital - 3222,Hefei,Anhui,China,231200 [72]Beijing Cancer Hospital - 3205,Beijing,Beijing,China [73]Cancer Hospital, Chinese Academy of Medical Sciences - 3211,Beijing,Beijing,China [74]Fujian Medical University Union Hospital - 3225,Fuzhou,Fujian,China [75]The First Affiliated Hospital of Xiamen University - 3210,Xiamen,Fujian,China [76]Dongguan People''s Hospital - 3206,Dongguan,Guangdong,China [77]Guangdong Provincial People''s Hospital - 3201,Guangzhou,Guangdong,China,510105 [78]Zhujiang Hospital of Southern Medical University - 3203,Guangzhou,Guangdong,China,510280 [79]The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215,Guangzhou,Guangdong,China [80]The People''s Hospital of Guangxi Zhuang Autonomous Region - 3228,Nanning,Guangxi,China,530021 [81]Hainan General Hospital - 3202,Haikou,Hainan,China [82]Affiliated Hospital of Hebei University - 3214,Zhengzhou,Hebei,China,71000 [83]The Affiliated Tumor Hospital of Harbin Medical University - 3232,Harbin,Heilongjiang,China,150040 [84]Henan Cancer Hospital - 3226,Zhengzhou,Henan,China,450008 [85]The First Affliated Hospital of Zhengzhou University - 3207,Zhengzhou,Henan,China [86]Renmin Hospital of Wuhan University - 3216,Wuhan,Hubei,China [87]Union Hospital Tongji Medical College - 3212,Wuhan,Hubei,China [88]Xiangya Hospital, Central South University - 3223,Changsha,Hunan,China,410008 [89]Hunan Cancer Hospital - 3209,Changsha,Hunan,China [90]The Second Affiliated Hospital of Soochow University - 3217,Suzhou,Jiangsu,China [91]Xuzhou Medical University - The Affiliated Hospital - 3234,Xuzhou,Jiangsu,China,221002 [92]The Second Affiliated Hospital of Nanchang University - 3224,Nanchang,Jiangxi,China,330006 [93]Jinan Central Hospital - 3230,Jinan,Shandong,China,250013 [94]Shanxi Bethune Hospital - 3233,Taiyuan,Shanxi,China,30032 [95]The First Affiliated Hospital of Xi''an Jiaotong University - 3218,Xi''an,Shanxi,China [96]Chengdu Seventh People''s Hospital - 3229,Chengdu,Sichuan,China,610041 [97]Sichuan Cancer Hospital - 3227,Chengdu,Sichuan,China,610041 [98]Chongqing University Cancer Hospital - 3213,Chongqing,Sichuan,China

研究目的:
The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

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