Actively Recruiting
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Led by OncoC4, Inc. · Updated on 2026-04-29
630
Participants Needed
152
Research Sites
270 weeks
Total Duration
On this page
Sponsors
O
OncoC4, Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older, any gender, able to provide informed consent
- Confirmed metastatic squamous non-small cell lung cancer by histology or cytology
- Disease progression after recent treatment with either at least 12 weeks of PD-1/PD-L1 inhibitor plus platinum chemotherapy or at least 2 cycles of platinum chemotherapy followed by 12 weeks of PD-1/PD-L1 inhibitor
- Allowed prior treatment with antibodies against CTLA-4, LAG-3, TIGIT, VEGF, or VEGFR along with PD-1/PD-L1 inhibitors
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function with serum LDH level less than or equal to twice the upper limit of normal
- Life expectancy of at least 3 months
You will not qualify if you...
- Cancer treatment-related adverse events not recovered to grade 1 or lower except for endocrinopathy
- Last dose of anti-PD-1/PD-L1 therapy within 28 days before starting study treatment
- Use of systemic steroids over 10 mg/day prednisone or equivalent within 7 days before starting treatment
- Presence of actionable mutations in EGFR, ALK, ROS1, HER2, MET, BRAF, RET, or NTRK genes (except KRAS mutations)
- Symptomatic brain metastases or recent palliative brain radiotherapy within 14 days prior to treatment
- Active gastrointestinal diseases such as peptic ulcer, pancreatitis, diverticulitis, or inflammatory bowel disease
- Active interstitial lung disease or non-infectious pneumonitis
- Active infections requiring intravenous antibiotics within 14 days before treatment
- Impaired heart function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 152 locations
1
XCancer/Dothan Hematology & Oncology - 1114
Dothan, Alabama, United States, 36303
Actively Recruiting
2
Genesis Cancer and Blood Institute - 1123
Russellville, Arkansas, United States, 72801
Actively Recruiting
3
The Oncology Institute (TOI) Clinical Research - 1109
Cerritos, California, United States, 90703
Actively Recruiting
4
Emad Ibrahim MD Inc. - 1147
Redlands, California, United States, 92373
Actively Recruiting
5
UC Davis Comprehensive Cancer Center - 1103
Sacramento, California, United States, 95817
Actively Recruiting
6
Bass Medical Group - 1155
Walnut Creek, California, United States, 94598
Actively Recruiting
7
Nuvance Health - 1118
Norwalk, Connecticut, United States, 06850
Actively Recruiting
8
D&H Cancer Research Center LLC - 1153
Margate, Florida, United States, 33063
Actively Recruiting
9
Ocala Oncology Center PL - 1102
Ocala, Florida, United States, 34474
Actively Recruiting
10
AdventHealth Cancer Institute - 1105
Orlando, Florida, United States, 32804
Actively Recruiting
11
Orlando Health - 1130
Orlando, Florida, United States, 32806
Actively Recruiting
12
Florida Cancer Specialists -South - 1126
Sarasota, Florida, United States, 34232
Actively Recruiting
13
Florida Cancer Specialists -North - 1125
The Villages, Florida, United States, 32159
Actively Recruiting
14
Florida Cancer Specialists -East - 1124
West Palm Beach, Florida, United States, 33401
Actively Recruiting
15
Orchard Healthcare Research, Inc. - 1116
Skokie, Illinois, United States, 60077
Actively Recruiting
16
Springfield Clinic - The Cancer Center - 1110
Springfield, Illinois, United States, 62702
Actively Recruiting
17
Fort Wayne Medical Oncology - 1133
Fort Wayne, Indiana, United States, 46805
Actively Recruiting
18
Deaconess Chancellor Center for Oncology - 1131
Newburgh, Indiana, United States, 47630
Actively Recruiting
19
Cotton O'Neil Clinical Research Center - 1151
Topeka, Kansas, United States, 66606
Actively Recruiting
20
University of Kentucky - Markey Cancer Center - 1112
Lexington, Kentucky, United States, 40536
Actively Recruiting
21
Norton Cancer Institute - 1108
Louisville, Kentucky, United States, 40202
Actively Recruiting
22
Jefferson City Medical Group - 1145
Jefferson City, Missouri, United States, 65109
Actively Recruiting
23
MidAmerica Cancer Care - 1163
Kansas City, Missouri, United States, 64132
Actively Recruiting
24
Astera Cancer Care - 1128
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
25
Duke University Medical Center - 1158
Durham, North Carolina, United States, 27710
Actively Recruiting
26
Miami Valley Hospital - 1115
Centerville, Ohio, United States, 45459
Actively Recruiting
27
University of Cincinnati Cancer Center - 1107
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
The Ohio State University James Cancer Center - 1104
Columbus, Ohio, United States, 43210
Actively Recruiting
29
Tri County Hematology & Oncology Associates, Inc - 1156
Massillon, Ohio, United States, 44646
Actively Recruiting
30
Oklahoma Cancer Specialists and Research Institute - 1154
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
31
Oncology Associates of Oregon - 1138
Eugene, Oregon, United States, 97401
Actively Recruiting
32
St. Luke's University Health Network - 1179
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
33
Donald Guthrie Foundation - 1135
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
34
Cancer Care Associates of York, Inc. - 1113
York, Pennsylvania, United States, 17403
Actively Recruiting
35
University of Tennessee Medical Center - 1146
Knoxville, Tennessee, United States, 37920
Actively Recruiting
36
Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
Nashville, Tennessee, United States, 37203
Actively Recruiting
37
Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
Dallas, Texas, United States, 75246
Actively Recruiting
38
Texas Oncology - Denison - 1139
Denison, Texas, United States, 75020
Actively Recruiting
39
Oncology Consultants, P.A. - 1120
Houston, Texas, United States, 77024
Actively Recruiting
40
Oncology and Hematology of South Texas - 1165
Laredo, Texas, United States, 78041
Actively Recruiting
41
Texas Oncology - McAllen - 1132
McAllen, Texas, United States, 78503
Actively Recruiting
42
Texas Oncology -San Antonio - 1122
San Antonio, Texas, United States, 78240
Actively Recruiting
43
NEXT Oncology - Virginia - 1129
Fairfax, Virginia, United States, 22031
Actively Recruiting
44
Virginia Cancer Institute - 1149
Henrico, Virginia, United States, 23226
Actively Recruiting
45
Virginia Oncology Associates - 1136
Norfolk, Virginia, United States, 23502
Actively Recruiting
46
West Virginia University Cancer Institute - 1172
Morgantown, West Virginia, United States, 26505
Actively Recruiting
47
Bankstown Hospital - 3305
Bankstown, New South Wales, Australia, 2200
Not Yet Recruiting
48
Mater - 3301
Newstead, Queensland, Australia, 4006
Not Yet Recruiting
49
Cancer Research SA - 3303
Adelaide, South Australia, Australia, 5000
Completed
50
Western Health - Sunshine Hospital - 3307
St Albans, Victoria, Australia, 3021
Not Yet Recruiting
51
AZ Maria Middelares - 2104
Ghent, Belgium, 9000
Actively Recruiting
52
Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
Hasselt, Belgium, 3500
Actively Recruiting
53
C. H. R. de la Citadelle - 2103
Liège, Belgium, 4000
Actively Recruiting
54
Vitaz - Sint-niklaas Moerland - 2101
Sint-Niklaas, Belgium, 9100
Actively Recruiting
55
BC Cancer Centre - Kelowna - 1203
Kelowna, British Columbia, Canada
Actively Recruiting
56
Saskatchewan Cancer Agency - Regina - 1201
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
57
Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
58
The First Affiliated Hospital of Anhui Medical University - 3221
Hefei, Anhui, China, 230022
Completed
59
Anhui Medical University - The Second Hospital - 3222
Hefei, Anhui, China, 231200
Completed
60
Beijing Cancer Hospital - 3205
Beijing, Beijing Municipality, China
Completed
61
Cancer Hospital, Chinese Academy of Medical Sciences - 3211
Beijing, Beijing Municipality, China
Completed
62
Fujian Medical University Union Hospital - 3225
Fuzhou, Fujian, China
Completed
63
The First Affiliated Hospital of Xiamen University - 3210
Xiamen, Fujian, China
Completed
64
Dongguan People's Hospital - 3206
Dongguan, Guangdong, China
Completed
65
Guangdong Provincial People's Hospital - 3201
Guangzhou, Guangdong, China, 510105
Completed
66
Zhujiang Hospital of Southern Medical University - 3203
Guangzhou, Guangdong, China, 510280
Completed
67
The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
Guangzhou, Guangdong, China
Completed
68
The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
Nanning, Guangxi, China, 530021
Completed
69
Hainan General Hospital - 3202
Haikou, Hainan, China
Completed
70
Affiliated Hospital of Hebei University - 3214
Zhengzhou, Hebei, China, 71000
Completed
71
The Affiliated Tumor Hospital of Harbin Medical University - 3232
Harbin, Heilongjiang, China, 150040
Completed
72
Henan Cancer Hospital - 3226
Zhengzhou, Henan, China, 450008
Completed
73
The First Affliated Hospital of Zhengzhou University - 3207
Zhengzhou, Henan, China
Completed
74
Renmin Hospital of Wuhan University - 3216
Wuhan, Hubei, China
Completed
75
Union Hospital Tongji Medical College - 3212
Wuhan, Hubei, China
Completed
76
Xiangya Hospital, Central South University - 3223
Changsha, Hunan, China, 410008
Completed
77
Hunan Cancer Hospital - 3209
Changsha, Hunan, China
Completed
78
The Second Affiliated Hospital of Soochow University - 3217
Suzhou, Jiangsu, China
Completed
79
Xuzhou Medical University - The Affiliated Hospital - 3234
Xuzhou, Jiangsu, China, 221002
Completed
80
The Second Affiliated Hospital of Nanchang University - 3224
Nanchang, Jiangxi, China, 330006
Completed
81
Jinan Central Hospital - 3230
Jinan, Shandong, China, 250013
Completed
82
Shanxi Bethune Hospital - 3233
Taiyuan, Shanxi, China, 30032
Completed
83
The First Affiliated Hospital of Xi'an Jiaotong University - 3218
Xi’an, Shanxi, China
Completed
84
Chengdu Seventh People's Hospital - 3229
Chengdu, Sichuan, China, 610041
Completed
85
Sichuan Cancer Hospital - 3227
Chengdu, Sichuan, China, 610041
Completed
86
Chongqing University Cancer Hospital - 3213
Chongqing, Sichuan, China
Completed
87
Tianjin Medical University Cancer Institute and Hospital - 3208
Tianjin, Tianjin Municipality, China
Completed
88
Yunnan Cancer Hospital - 3231
Kunming, Yunnan, China, 650118
Completed
89
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
Hangzhou, Zhejiang, China
Completed
90
The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
Hangzhou, Zhejiang, China
Completed
91
Zhejiang Cancer Hospital - 3204
Hangzhou, Zhejiang, China
Completed
92
China-Japan Friendship Hospital - 3236
Beijing, China, 100029
Completed
93
West China Hospital, Sichuan University - 3238
Chengdu, China, 610041
Completed
94
Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
Jiangse, China, 21006
Completed
95
Weifang Second People's Hospital - 3235
Shandong, China, 261041
Completed
96
Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
Shanghai, China, 200120
Completed
97
Hubei Cancer Hospital - 3237
Wuhan, China, 430079
Completed
98
Städt. Klinikum München GmbH - 2204
Bogenhausen, Germany, 81925
Actively Recruiting
99
Kliniken Essen-Mitte - 2206
Essen, Germany, 45136
Actively Recruiting
100
Klinikum Esslingen GmbH - 2201
Esslingen am Neckar, Germany, 73730
Actively Recruiting
101
Lungenfachklinik Immenhausen - 2202
Immenhausen, Germany, 34376
Actively Recruiting
102
Klinikverbund Allgaü - Klinikum Kempten - 2205
Immenstädt, Germany, 87509
Actively Recruiting
103
Asklepios Fachkliniken Muenchen-Gauting - 2203
Muenchen-Gauting, Germany, 82131
Actively Recruiting
104
Clinica Oncologica Ospedali Riuniti Ancona - 2311
Ancona, Italy, 60126
Actively Recruiting
105
IRCCS Istituto Tumori Giovanni Paolo II - 2306
Bari, Italy, 70124
Actively Recruiting
106
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
Bergamo, Italy, 24126
Actively Recruiting
107
Humanitas Istituto Clinico Catanese - 2312
Catania, Italy, 95045
Actively Recruiting
108
Ospedale San Raffaele - 2307
Milan, Italy, 20132
Actively Recruiting
109
Fondazione IRCCS Instituto Tumori Di Milano - 2305
Milan, Italy, 20133
Not Yet Recruiting
110
Ospedale San Gerardo di Monza - 2302
Monza, Italy, 20900
Actively Recruiting
111
Azienda Ospedaliera Universitaria "Federico II" - 2304
Naples, Italy, 80131
Actively Recruiting
112
AOU Policlinico Giaccone, Università di Palermo - 2309
Palermo, Italy, 90129
Actively Recruiting
113
Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
Perugia, Italy, 06132
Actively Recruiting
114
Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
Roma, Italy, 00128
Actively Recruiting
115
Antoni van Leeuwenhoek - 2703
Amsterdam, Netherlands, 1066 CV
Actively Recruiting
116
Rijnstate Ziekenhuis - 2701
Arnhem, Netherlands, 6815
Actively Recruiting
117
ETZ Elisabeth - 2704
Tilburg, Netherlands, 5022 GC
Actively Recruiting
118
Chungbuk National University Hospital - 3101
Cheongju-si, South Korea, 28644
Actively Recruiting
119
Keimyung University Dongsan Hospital - 3102
Daegu, South Korea, 42601
Actively Recruiting
120
National Cancer Center - 3107
Goyang-si, South Korea, 10408
Actively Recruiting
121
Severance Hospital, Yonsei University Health System - 3104
Seoul, South Korea, 03722
Actively Recruiting
122
Asan Medical Centre - 3103
Seoul, South Korea, 05505
Actively Recruiting
123
Korea University Guro Hospital - 3106
Seoul, South Korea, 08308
Actively Recruiting
124
The Catholic University of Korea, St Vincent's Hospital - 3105
Suwon, South Korea, 16247
Actively Recruiting
125
Hospital General Universitario de Elche - 2401
Elche, Spain, 03203
Actively Recruiting
126
Hospital Universitario Lucus Augusti - 2405
Lugo, Spain, 27003
Actively Recruiting
127
Hospital General Universitario Gregorio Marañon - 2404
Madrid, Spain, 28007
Actively Recruiting
128
Hospital Regional Universitario de Malaga - 2403
Málaga, Spain, 29010
Actively Recruiting
129
Hospital General Universitario de Valencia - 2406
Valencia, Spain, 46014
Actively Recruiting
130
Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
Valencia, Spain, 56009
Actively Recruiting
131
Adana Sehir Hastanesi - 2602
Adana, Turkey (Türkiye)
Actively Recruiting
132
Baskent University Adana - 2601
Adana, Turkey (Türkiye)
Actively Recruiting
133
Hacettepe Universitesi - 2609
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
134
Ankara Bilkent Sehir Hastanesi - 2610
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
135
Akdeniz University Medical Hospital - 2606
Antalya, Turkey (Türkiye)
Actively Recruiting
136
Trakya University Faculty of Medicine Edirne - 2608
Edirne, Turkey (Türkiye)
Actively Recruiting
137
Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
Fatih, Turkey (Türkiye), 34093
Actively Recruiting
138
Koc Universitesi - 2611
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
139
Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
Istanbul, Turkey (Türkiye)
Actively Recruiting
140
Istanbul Bakirkoy Sadi Konuk - 2604
Istanbul, Turkey (Türkiye)
Actively Recruiting
141
Medipol University Medical Faculty Hospital - 2603
Istanbul, Turkey (Türkiye)
Actively Recruiting
142
Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
Izmir, Turkey (Türkiye)
Actively Recruiting
143
University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
Birmingham, England, United Kingdom, B15 2TG
Actively Recruiting
144
Cambridge University Hospitals - 2804
Cambridge, England, United Kingdom, CB2 0QQ
Actively Recruiting
145
Royal Devon University Healthcare NHS - 2808
Exeter, England, United Kingdom, EX25DW
Not Yet Recruiting
146
University Hospital Leicester - 2806
Leicester, England, United Kingdom, LE1 5WW
Actively Recruiting
147
Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803
London, England, United Kingdom, EC1A 7BE
Actively Recruiting
148
South Tees Hospitals - 2807
Middlesbrough, England, United Kingdom, TS4 3BW
Actively Recruiting
149
Torbay and South Devon NHS Foundation Trust - 2805
Torquay, England, United Kingdom, TQ2 7AA
Actively Recruiting
150
The Christie NHS Foundation Trust - 2802
Manchester, London, United Kingdom, M20 4BX
Actively Recruiting
151
Edinburgh Cancer Centre - 2809
Edinburgh, Scotland, United Kingdom, EH54 6PP
Actively Recruiting
152
University College London Hospital - 2811
London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
P
Pan Zheng, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here