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Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

Status: Recruiting
Location: See all (152) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this Phase 3 clinical trial is to 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult (≥ 18 years), all genders, capable of signing informed consent.

• Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.

• Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:

‣ At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;

⁃ Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.

• Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.

• At least one measurable tumor lesion according to RECIST 1.1.

• ECOG score of 0 or 1.

• Adequate organ functions. Serum LDH level ≤ 2xULN.

• Life expectancy ≥ 3 months.

Locations
United States
Alabama
XCancer/Dothan Hematology & Oncology - 1114
RECRUITING
Dothan
Arkansas
Genesis Cancer and Blood Institute - 1123
RECRUITING
Russellville
California
The Oncology Institute (TOI) Clinical Research - 1109
RECRUITING
Cerritos
Emad Ibrahim MD Inc. - 1147
RECRUITING
Redlands
UC Davis Comprehensive Cancer Center - 1103
RECRUITING
Sacramento
Bass Medical Group - 1155
RECRUITING
Walnut Creek
Connecticut
Nuvance Health - 1118
RECRUITING
Norwalk
Florida
D&H Cancer Research Center LLC - 1153
RECRUITING
Margate
Ocala Oncology Center PL - 1102
RECRUITING
Ocala
AdventHealth Cancer Institute - 1105
RECRUITING
Orlando
Orlando Health - 1130
RECRUITING
Orlando
Florida Cancer Specialists -South - 1126
RECRUITING
Sarasota
Florida Cancer Specialists -North - 1125
RECRUITING
The Villages
Florida Cancer Specialists -East - 1124
RECRUITING
West Palm Beach
Illinois
Orchard Healthcare Research, Inc. - 1116
RECRUITING
Skokie
Springfield Clinic - The Cancer Center - 1110
RECRUITING
Springfield
Indiana
Fort Wayne Medical Oncology - 1133
RECRUITING
Fort Wayne
Deaconess Chancellor Center for Oncology - 1131
RECRUITING
Newburgh
Kansas
Cotton O'Neil Clinical Research Center - 1151
RECRUITING
Topeka
Kentucky
University of Kentucky - Markey Cancer Center - 1112
RECRUITING
Lexington
Norton Cancer Institute - 1108
RECRUITING
Louisville
Missouri
Jefferson City Medical Group - 1145
RECRUITING
Jefferson City
MidAmerica Cancer Care - 1163
RECRUITING
Kansas City
North Carolina
Duke University Medical Center - 1158
RECRUITING
Durham
New Jersey
Astera Cancer Care - 1128
RECRUITING
East Brunswick
Ohio
Miami Valley Hospital - 1115
RECRUITING
Centerville
University of Cincinnati Cancer Center - 1107
RECRUITING
Cincinnati
The Ohio State University James Cancer Center - 1104
RECRUITING
Columbus
Tri County Hematology & Oncology Associates, Inc - 1156
RECRUITING
Massillon
Oklahoma
Oklahoma Cancer Specialists and Research Institute - 1154
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon - 1138
RECRUITING
Eugene
Pennsylvania
St. Luke's University Health Network - 1179
RECRUITING
Bethlehem
Donald Guthrie Foundation - 1135
RECRUITING
Sayre
Cancer Care Associates of York, Inc. - 1113
RECRUITING
York
Tennessee
University of Tennessee Medical Center - 1146
RECRUITING
Knoxville
Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
RECRUITING
Nashville
Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
RECRUITING
Dallas
Texas Oncology - Denison - 1139
RECRUITING
Denison
Oncology Consultants, P.A. - 1120
RECRUITING
Houston
Oncology and Hematology of South Texas - 1165
RECRUITING
Laredo
Texas Oncology - McAllen - 1132
RECRUITING
Mcallen
Texas Oncology -San Antonio - 1122
RECRUITING
San Antonio
Virginia
NEXT Oncology - Virginia - 1129
RECRUITING
Fairfax
Virginia Cancer Institute - 1149
RECRUITING
Henrico
Virginia Oncology Associates - 1136
RECRUITING
Norfolk
West Virginia
West Virginia University Cancer Institute - 1172
RECRUITING
Morgantown
Other Locations
Australia
Cancer Research SA - 3303
COMPLETED
Adelaide
Bankstown Hospital - 3305
NOT_YET_RECRUITING
Bankstown
Mater - 3301
NOT_YET_RECRUITING
Newstead
Western Health - Sunshine Hospital - 3307
NOT_YET_RECRUITING
St Albans
Belgium
AZ Maria Middelares - 2104
RECRUITING
Ghent
Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
RECRUITING
Hasselt
C. H. R. de la Citadelle - 2103
RECRUITING
Liège
Vitaz - Sint-niklaas Moerland - 2101
RECRUITING
Sint-niklaas
Canada
BC Cancer Centre - Kelowna - 1203
RECRUITING
Kelowna
Saskatchewan Cancer Agency - Regina - 1201
RECRUITING
Regina
Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
RECRUITING
Saskatoon
China
Beijing Cancer Hospital - 3205
COMPLETED
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences - 3211
COMPLETED
Beijing
China-Japan Friendship Hospital - 3236
COMPLETED
Beijing
Hunan Cancer Hospital - 3209
COMPLETED
Changsha
Xiangya Hospital, Central South University - 3223
COMPLETED
Changsha
Chengdu Seventh People's Hospital - 3229
COMPLETED
Chengdu
Sichuan Cancer Hospital - 3227
COMPLETED
Chengdu
West China Hospital, Sichuan University - 3238
COMPLETED
Chengdu
Chongqing University Cancer Hospital - 3213
COMPLETED
Chongqing
Dongguan People's Hospital - 3206
COMPLETED
Dongguan
Fujian Medical University Union Hospital - 3225
COMPLETED
Fuzhou
Guangdong Provincial People's Hospital - 3201
COMPLETED
Guangzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
COMPLETED
Guangzhou
Zhujiang Hospital of Southern Medical University - 3203
COMPLETED
Guangzhou
Hainan General Hospital - 3202
COMPLETED
Haikou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
COMPLETED
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
COMPLETED
Hangzhou
Zhejiang Cancer Hospital - 3204
COMPLETED
Hangzhou
The Affiliated Tumor Hospital of Harbin Medical University - 3232
COMPLETED
Harbin
Anhui Medical University - The Second Hospital - 3222
COMPLETED
Hefei
The First Affiliated Hospital of Anhui Medical University - 3221
COMPLETED
Hefei
Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
COMPLETED
Jiangse
Jinan Central Hospital - 3230
COMPLETED
Jinan
Yunnan Cancer Hospital - 3231
COMPLETED
Kunming
The Second Affiliated Hospital of Nanchang University - 3224
COMPLETED
Nanchang
The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
COMPLETED
Nanning
Weifang Second People's Hospital - 3235
COMPLETED
Shandong
Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
COMPLETED
Shanghai
The Second Affiliated Hospital of Soochow University - 3217
COMPLETED
Suzhou
Shanxi Bethune Hospital - 3233
COMPLETED
Taiyuan
Tianjin Medical University Cancer Institute and Hospital - 3208
COMPLETED
Tianjin
Hubei Cancer Hospital - 3237
COMPLETED
Wuhan
Renmin Hospital of Wuhan University - 3216
COMPLETED
Wuhan
Union Hospital Tongji Medical College - 3212
COMPLETED
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University - 3218
COMPLETED
Xi’an
The First Affiliated Hospital of Xiamen University - 3210
COMPLETED
Xiamen
Xuzhou Medical University - The Affiliated Hospital - 3234
COMPLETED
Xuzhou
Affiliated Hospital of Hebei University - 3214
COMPLETED
Zhengzhou
Henan Cancer Hospital - 3226
COMPLETED
Zhengzhou
The First Affliated Hospital of Zhengzhou University - 3207
COMPLETED
Zhengzhou
Germany
Städt. Klinikum München GmbH - 2204
RECRUITING
Bogenhausen
Kliniken Essen-Mitte - 2206
RECRUITING
Essen
Klinikum Esslingen GmbH - 2201
RECRUITING
Esslingen Am Neckar
Lungenfachklinik Immenhausen - 2202
RECRUITING
Immenhausen
Klinikverbund Allgaü - Klinikum Kempten - 2205
RECRUITING
Immenstädt
Asklepios Fachkliniken Muenchen-Gauting - 2203
RECRUITING
Muenchen-gauting
Italy
Clinica Oncologica Ospedali Riuniti Ancona - 2311
RECRUITING
Ancona
IRCCS Istituto Tumori Giovanni Paolo II - 2306
RECRUITING
Bari
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
RECRUITING
Bergamo
Humanitas Istituto Clinico Catanese - 2312
RECRUITING
Catania
Fondazione IRCCS Instituto Tumori Di Milano - 2305
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele - 2307
RECRUITING
Milan
Ospedale San Gerardo di Monza - 2302
RECRUITING
Monza
Azienda Ospedaliera Universitaria Federico II - 2304
RECRUITING
Naples
AOU Policlinico Giaccone, Università di Palermo - 2309
RECRUITING
Palermo
Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
RECRUITING
Perugia
Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
RECRUITING
Roma
Netherlands
Antoni van Leeuwenhoek - 2703
RECRUITING
Amsterdam
Rijnstate Ziekenhuis - 2701
RECRUITING
Arnhem
ETZ Elisabeth - 2704
RECRUITING
Tilburg
Republic of Korea
Chungbuk National University Hospital - 3101
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital - 3102
RECRUITING
Daegu
National Cancer Center - 3107
RECRUITING
Goyang-si
Asan Medical Centre - 3103
RECRUITING
Seoul
Korea University Guro Hospital - 3106
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System - 3104
RECRUITING
Seoul
The Catholic University of Korea, St Vincent's Hospital - 3105
RECRUITING
Suwon
Spain
Hospital General Universitario de Elche - 2401
RECRUITING
Elche
Hospital Universitario Lucus Augusti - 2405
RECRUITING
Lugo
Hospital General Universitario Gregorio Marañon - 2404
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - 2403
RECRUITING
Málaga
Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
RECRUITING
Valencia
Hospital General Universitario de Valencia - 2406
RECRUITING
Valencia
Turkey
Adana Sehir Hastanesi - 2602
RECRUITING
Adana
Baskent University Adana - 2601
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi - 2610
RECRUITING
Ankara
Hacettepe Universitesi - 2609
RECRUITING
Ankara
Akdeniz University Medical Hospital - 2606
RECRUITING
Antalya
Trakya University Faculty of Medicine Edirne - 2608
RECRUITING
Edirne
Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
RECRUITING
Fatih
Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
RECRUITING
Istanbul
Istanbul Bakirkoy Sadi Konuk - 2604
RECRUITING
Istanbul
Koc Universitesi - 2611
RECRUITING
Istanbul
Medipol University Medical Faculty Hospital - 2603
RECRUITING
Istanbul
Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
RECRUITING
Izmir
United Kingdom
University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
RECRUITING
Birmingham
Cambridge University Hospitals - 2804
RECRUITING
Cambridge
Edinburgh Cancer Centre - 2809
RECRUITING
Edinburgh
Royal Devon University Healthcare NHS - 2808
NOT_YET_RECRUITING
Exeter
University Hospital Leicester - 2806
RECRUITING
Leicester
Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803
RECRUITING
London
University College London Hospital - 2811
RECRUITING
London
The Christie NHS Foundation Trust - 2802
RECRUITING
Manchester
South Tees Hospitals - 2807
RECRUITING
Middlesbrough
Torbay and South Devon NHS Foundation Trust - 2805
RECRUITING
Torquay
Contact Information
Primary
Pan Zheng, MD, PhD
pzheng@oncoc4.com
2027516823
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 630
Treatments
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.
Active_comparator: Arm 2: 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.
Sponsors
Leads: OncoC4, Inc.
Collaborators: BioNTech SE

This content was sourced from clinicaltrials.gov

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