ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
- Registration Number
- NCT05671510
- Lead Sponsor
- OncoC4, Inc.
- Brief Summary
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.
- Detailed Description
This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor. Approximately 600 patients will be enrolled.
Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for Stage II.
Stage I, the dose-confirmation stage, will assess the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W.
Stage II will assess the safety and efficacy of gotistobart at the selected dosing regimen versus docetaxel. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W Gotistobart Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. Arm 2: Gotistobart 3 mg/kg Q3W Gotistobart Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. Arm 3: Docetaxel 75 mg/m2, Q3W Docetaxel Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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 Measures
Name Time Method Objective response rate (ORR) 36 months Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Treatment emergent adverse events, treatment related adverse events and immune related adverse events. 36 months Incidence of TEAEs, TRAEs, irAEs will be calcuated. The AEs leading to treatment discontinuation will be recorded.
Progression-free survival (PFS) 36 months Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1
Trial Locations
- Locations (163)
Bankstown Hospital - 3305
🇦🇺Bankstown, New South Wales, Australia
Newcastle Private Hospital - 3302
🇦🇺New Lambton Heights, New South Wales, Australia
Mater - 3301
🇦🇺Newstead, Queensland, Australia
Cancer Research SA - 3303
🇦🇺Adelaide, South Australia, Australia
AZ Maria Middelares - 2104
🇧🇪Gent, Belgium
Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
🇧🇪Hasselt, Belgium
C. H. R. de la Citadelle - 2103
🇧🇪Liège, Belgium
Nuvance Health - 1118
🇺🇸Norwalk, Connecticut, United States
XCancer/Dothan Hematology & Oncology - 1114
🇺🇸Dothan, Alabama, United States
Genesis Cancer and Blood Institute - 1123
🇺🇸Russellville, Arkansas, United States
The Oncology Institute (TOI) Clinical Research - 1109
🇺🇸Cerritos, California, United States
Emad Ibrahim MD Inc. - 1147
🇺🇸Redlands, California, United States
UC Davis Comprehensive Cancer Center - 1103
🇺🇸Sacramento, California, United States
Bass Medical Group - 1155
🇺🇸Walnut Creek, California, United States
D&H Cancer Research Center LLC - 1153
🇺🇸Margate, Florida, United States
Ocala Oncology Center PL - 1102
🇺🇸Ocala, Florida, United States
AdventHealth Cancer Institute - 1105
🇺🇸Orlando, Florida, United States
Orlando Health - 1130
🇺🇸Orlando, Florida, United States
Florida Cancer Specialists -South - 1126
🇺🇸Sarasota, Florida, United States
Florida Cancer Specialists -North - 1125
🇺🇸The Villages, Florida, United States
Florida Cancer Specialists -East - 1124
🇺🇸West Palm Beach, Florida, United States
Orchard Healthcare Research, Inc. - 1116
🇺🇸Skokie, Illinois, United States
Springfield Clinic - The Cancer Center - 1110
🇺🇸Springfield, Illinois, United States
Fort Wayne Medical Oncology - 1133
🇺🇸Fort Wayne, Indiana, United States
Deaconess Chancellor Center for Oncology - 1131
🇺🇸Newburgh, Indiana, United States
Alliance for Multispecialty Research, LLC - 1144
🇺🇸Merriam, Kansas, United States
Cotton O'Neil Clinical Research Center - 1151
🇺🇸Topeka, Kansas, United States
University of Kentucky - Markey Cancer Center - 1112
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute - 1108
🇺🇸Louisville, Kentucky, United States
Hematology Oncology Clinics - Baton Rouge - 1142
🇺🇸Baton Rouge, Louisiana, United States
HealthPartners Institute, Cancer Research Center - 1143
🇺🇸Saint Louis Park, Minnesota, United States
Jefferson City Medical Group - 1145
🇺🇸Jefferson City, Missouri, United States
NHO-Revive Research Institute, LLC - 1152
🇺🇸Lincoln, Nebraska, United States
Astera Cancer Care - 1128
🇺🇸East Brunswick, New Jersey, United States
Messino Cancer Centers - 1121
🇺🇸Asheville, North Carolina, United States
University of Cincinnati Cancer Center - 1107
🇺🇸Cincinnati, Ohio, United States
The Ohio State University James Cancer Center - 1104
🇺🇸Columbus, Ohio, United States
Miami Valley Hospital - 1115
🇺🇸Dayton, Ohio, United States
Tri County Hematology & Oncology Associates, Inc - 1156
🇺🇸Massillon, Ohio, United States
Oncology Associates of Oregon - 1138
🇺🇸Eugene, Oregon, United States
Pennsylvania Cancer Specialists Research Institute - 1101
🇺🇸Gettysburg, Pennsylvania, United States
Donald Guthrie Foundation - 1135
🇺🇸Sayre, Pennsylvania, United States
Cancer Care Associates of York, Inc. - 1113
🇺🇸York, Pennsylvania, United States
University of Tennessee Medical Center - 1146
🇺🇸Knoxville, Tennessee, United States
Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
🇺🇸Nashville, Tennessee, United States
Texas Oncology -Dallas - 1127
🇺🇸Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
🇺🇸Dallas, Texas, United States
Texas Oncology - Denison - 1139
🇺🇸Denison, Texas, United States
Texas Oncology - Fort Worth Cancer Center - 1141
🇺🇸Fort Worth, Texas, United States
Oncology Consultants, P.A. - 1120
🇺🇸Houston, Texas, United States
Texas Oncology - McAllen - 1132
🇺🇸McAllen, Texas, United States
Texas Oncology - Plano West - 1137
🇺🇸Plano, Texas, United States
Texas Oncology -San Antonio - 1122
🇺🇸San Antonio, Texas, United States
Texas Oncology - Northeast Texas - Tyler - 1134
🇺🇸Tyler, Texas, United States
NEXT Oncology - Virginia - 1129
🇺🇸Fairfax, Virginia, United States
Virginia Cancer Institute - 1149
🇺🇸Henrico, Virginia, United States
Virginia Oncology Associates - 1136
🇺🇸Norfolk, Virginia, United States
MultiCare Institute for Research and Innovation - Tacoma - 1148
🇺🇸Spokane, Washington, United States
Vitaz - Sint-niklaas Moerland - 2101
🇧🇪Sint-Niklaas, Belgium
BC Cancer Centre - Kelowna - 1203
🇨🇦Kelowna, British Columbia, Canada
Saskatchewan Cancer Agency - Regina - 1201
🇨🇦Regina, Saskatchewan, Canada
Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
🇨🇦Saskatoon, Saskatchewan, Canada
Santa Cabrini Hospital - 1204
🇨🇦Québec, Canada
The First Affiliated Hospital of Anhui Medical University - 3221
🇨🇳Hefei, Anhui, China
Anhui Medical University - The Second Hospital - 3222
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital - 3205
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences - 3211
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital - 3225
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University - 3210
🇨🇳Xiamen, Fujian, China
Dongguan People's Hospital - 3206
🇨🇳Dongguan, Guangdong, China
Guangdong Provincial People's Hospital - 3201
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University - 3203
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
🇨🇳Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
🇨🇳Nanning, Guangxi, China
Hainan General Hospital - 3202
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Hebei University - 3214
🇨🇳Zhengzhou, Hebei, China
The Affiliated Tumor Hospital of Harbin Medical University - 3232
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital - 3226
🇨🇳Zhengzhou, Henan, China
The First Affliated Hospital of Zhengzhou University - 3207
🇨🇳Zhengzhou, Henan, China
Renmin Hospital of Wuhan University - 3216
🇨🇳Wuhan, Hubei, China
Union Hospital Tongji Medical College - 3212
🇨🇳Wuhan, Hubei, China
Xiangya Hospital, Central South University - 3223
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital - 3209
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University - 3217
🇨🇳Suzhou, Jiangsu, China
Xuzhou Medical University - The Affiliated Hospital - 3234
🇨🇳Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University - 3224
🇨🇳Nanchang, Jiangxi, China
Jinan Central Hospital - 3230
🇨🇳Jinan, Shandong, China
Shanxi Bethune Hospital - 3233
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University - 3218
🇨🇳Xi'an, Shanxi, China
Chengdu Seventh People's Hospital - 3229
🇨🇳Chengdu, Sichuan, China
Sichuan Cancer Hospital - 3227
🇨🇳Chengdu, Sichuan, China
Chongqing University Cancer Hospital - 3213
🇨🇳Chongqing, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital - 3208
🇨🇳Tianjin, Tianjin, China
Yunnan Cancer Hospital - 3231
🇨🇳Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital - 3204
🇨🇳Hangzhou, Zhejiang, China
China-Japan Friendship Hospital - 3236
🇨🇳Beijing, China
West China Hospital, Sichuan University - 3238
🇨🇳Chengdu, China
Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
🇨🇳Jiangse, China
Weifang Second People's Hospital - 3235
🇨🇳Shandong, China
Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
🇨🇳Shanghai, China
Hubei Cancer Hospital - 3237
🇨🇳Wuhan, China
Hôpital Ambroise Paré - 2501
🇫🇷Billancourt, France
Centre Hospitalier Intercommunal de Créteil - 2502
🇫🇷Créteil, France
CHU Limoges - Hospital du Cluzeau - 2503
🇫🇷Limoges, France
Städt. Klinikum München GmbH - 2204
🇩🇪Bogenhausen, Germany
Kliniken Essen-Mitte - 2206
🇩🇪Essen, Germany
Klinikum Esslingen GmbH - 2201
🇩🇪Esslingen am Neckar, Germany
Lungenfachklinik Immenhausen - 2202
🇩🇪Immenhausen, Germany
Klinikverbund Allgaü - Klinikum Kempten - 2205
🇩🇪Immenstädt, Germany
Asklepios Fachkliniken Muenchen-Gauting - 2203
🇩🇪Muenchen-Gauting, Germany
Clinica Oncologica Ospedali Riuniti Ancona - 2311
🇮🇹Ancona, Italy
IRCCS Istituto Tumori Giovanni Paolo II - 2306
🇮🇹Bari, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
🇮🇹Bergamo, Italy
Azienda Ospedaliera Papardo - 2301
🇮🇹Messina, Italy
Ospedale San Raffaele - 2307
🇮🇹Milano, Italy
Fondazione IRCCS Instituto Tumori Di Milano - 2305
🇮🇹Milano, Italy
Ospedale San Gerardo di Monza - 2302
🇮🇹Monza, Italy
Azienda Ospedaliera Universitaria "Federico II" - 2304
🇮🇹Naples, Italy
AOU Policlinico Giaccone, Università di Palermo - 2309
🇮🇹Palermo, Italy
Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
🇮🇹Perugia, Italy
Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
🇮🇹Roma, Italy
Chungbuk National University Hospital - 3101
🇰🇷Cheongju-si, Korea, Republic of
Keimyung University Dongsan Hospital - 3102
🇰🇷Daegu, Korea, Republic of
National Cancer Center - 3107
🇰🇷Goyang-si, Korea, Republic of
Severance Hospital, Yonsei University Health System - 3104
🇰🇷Seoul, Korea, Republic of
Asan Medical Centre - 3103
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital - 3106
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St Vincent's Hospital - 3105
🇰🇷Suwon, Korea, Republic of
Antoni van Leeuwenhoek - 2703
🇳🇱Amsterdam, Netherlands
Rijnstate Ziekenhuis - 2701
🇳🇱Arnhem, Netherlands
Jeroen Bosch Ziekenhuis - 2702
🇳🇱Herzogenbusch, Netherlands
ETZ Elisabeth - 2704
🇳🇱Tilburg, Netherlands
Hospital General Universitario de Elche - 2401
🇪🇸Elche, Spain
Hospital Universitario Lucus Augusti - 2405
🇪🇸Lugo, Spain
Hospital General Universitario Gregorio Marañon - 2404
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga - 2403
🇪🇸Málaga, Spain
Hospital General Universitario de Valencia - 2406
🇪🇸Valencia, Spain
Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
🇪🇸Valencia, Spain
Adana Sehir Hastanesi - 2602
🇹🇷Adana, Turkey
Baskent University Adana - 2601
🇹🇷Adana, Turkey
Hacettepe Universitesi - 2609
🇹🇷Ankara, Turkey
Ankara Bilkent Sehir Hastanesi - 2610
🇹🇷Ankara, Turkey
Akdeniz University Medical Hospital - 2606
🇹🇷Antalya, Turkey
Ege Universitesi Hastanesi - 2612
🇹🇷Bornova, Turkey
Trakya University Faculty of Medicine Edirne - 2608
🇹🇷Edirne, Turkey
Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
🇹🇷Fatih, Turkey
Koc Universitesi - 2611
🇹🇷Istanbul, Turkey
Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
🇹🇷Istanbul, Turkey
Istanbul Bakirkoy Sadi Konuk - 2604
🇹🇷Istanbul, Turkey
Medipol University Medical Faculty Hospital - 2603
🇹🇷Istanbul, Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
🇹🇷İzmir, Turkey
University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
🇬🇧Birmingham, England, United Kingdom
Cambridge University Hospitals - 2804
🇬🇧Cambridge, England, United Kingdom
Royal Devon University Healthcare NHS - 2808
🇬🇧Exeter, England, United Kingdom
University Hospital Leicester - 2806
🇬🇧Leicester, England, United Kingdom
The Christie NHS Foundation Trust - 2803
🇬🇧London, England, United Kingdom
Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802
🇬🇧Manchester, England, United Kingdom
South Tees Hospitals - 2807
🇬🇧Middlesbrough, England, United Kingdom
University Hospital Southampton - 2810
🇬🇧Southampton, England, United Kingdom
Torbay Hospital - Horizon Centre - 2805
🇬🇧Torquay, England, United Kingdom
Edinburgh Cancer Centre - 2809
🇬🇧Edinburgh, Scotland, United Kingdom