Clinical trials›Non Small Cell Lung Cancer›Injection›Trial details
ActiveComing Soon (1–3 yrs) Treatment Study

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

For Condition: Non Small Cell Lung Cancer

ID: NCT05671510

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Injections / IV Shots
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

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.

Read Full Scientific Objectives & Methods

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 630 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 on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Study Timeline & Quick Facts
Trial Status
In Progress (Not Taking New Patients)
Total Target Enrollment
630 patients (Estimated)
Study Start Date
2023-06-28
Est. Primary Completion
2027-08-31
Tested Drugs & Treatment Groups
DRUGGotistobart

Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

DRUGDocetaxel

Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.

Treatment Arms Description

EXPERIMENTALArm 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_COMPARATORArm 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.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can Join
  • 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.
Who Cannot Join
  • Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
  • Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
  • Receiving systemic steroid therapy with \>10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
  • Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded.
  • Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
  • Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
  • Active interstitial lung disease (ILD) or non-infectious pneumonitis.
  • Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
  • Impaired heart function.
What is this Study Measuring?

Primary Outcome Measures

  • 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.

View Secondary Outcome Measures (3)
  • Objective response rate (ORR) — Time Frame: 36 months

    Objective response rate (ORR) as assessed by the Investigator per RECIST 1.1

  • Progression-free survival (PFS) — Time Frame: 36 months

    Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1

  • Treatment emergent adverse events, treatment related adverse events and immune related adverse events. — Time Frame: 36 months

    Incidence of TEAEs, TRAEs, irAEs will be calculated. The AEs leading to treatment discontinuation will be recorded.

Where to Participate

This trial is recruiting at 152 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 152 Facilities & Contact Sites
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
Nuvance Health - 1118
Norwalk, Connecticut, 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
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
Jefferson City Medical Group - 1145
Jefferson City, Missouri, United States
MidAmerica Cancer Care - 1163
Kansas City, Missouri, United States
Astera Cancer Care - 1128
East Brunswick, New Jersey, United States
Duke University Medical Center - 1158
Durham, North Carolina, United States
Miami Valley Hospital - 1115
Centerville, Ohio, United States
University of Cincinnati Cancer Center - 1107
Cincinnati, Ohio, United States
The Ohio State University James Cancer Center - 1104
Columbus, Ohio, United States
Tri County Hematology & Oncology Associates, Inc - 1156
Massillon, Ohio, United States
Oklahoma Cancer Specialists and Research Institute - 1154
Tulsa, Oklahoma, United States
Oncology Associates of Oregon - 1138
Eugene, Oregon, United States
St. Luke's University Health Network - 1179
Bethlehem, 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 - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
Dallas, Texas, United States
Texas Oncology - Denison - 1139
Denison, Texas, United States
Oncology Consultants, P.A. - 1120
Houston, Texas, United States
Oncology and Hematology of South Texas - 1165
Laredo, Texas, United States
Texas Oncology - McAllen - 1132
McAllen, Texas, United States
Texas Oncology -San Antonio - 1122
San Antonio, 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
West Virginia University Cancer Institute - 1172
Morgantown, West Virginia, United States
Bankstown Hospital - 3305
Bankstown, New South Wales, Australia
Mater - 3301
Newstead, Queensland, Australia
Cancer Research SA - 3303
Adelaide, South Australia, Australia
Western Health - Sunshine Hospital - 3307
St Albans, Victoria, Australia
AZ Maria Middelares - 2104
Ghent, Belgium
Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
Hasselt, Belgium
C. H. R. de la Citadelle - 2103
Liège, Belgium
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
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 Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences - 3211
Beijing, Beijing Municipality, 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 Municipality, 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
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
Humanitas Istituto Clinico Catanese - 2312
Catania, Italy
Ospedale San Raffaele - 2307
Milan, Italy
Fondazione IRCCS Instituto Tumori Di Milano - 2305
Milan, 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
Antoni van Leeuwenhoek - 2703
Amsterdam, Netherlands
Rijnstate Ziekenhuis - 2701
Arnhem, Netherlands
ETZ Elisabeth - 2704
Tilburg, Netherlands
Chungbuk National University Hospital - 3101
Cheongju-si, South Korea
Keimyung University Dongsan Hospital - 3102
Daegu, South Korea
National Cancer Center - 3107
Goyang-si, South Korea
Severance Hospital, Yonsei University Health System - 3104
Seoul, South Korea
Asan Medical Centre - 3103
Seoul, South Korea
Korea University Guro Hospital - 3106
Seoul, South Korea
The Catholic University of Korea, St Vincent's Hospital - 3105
Suwon, South Korea
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 (Türkiye)
Baskent University Adana - 2601
Adana, Turkey (Türkiye)
Hacettepe Universitesi - 2609
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi - 2610
Ankara, Turkey (Türkiye)
Akdeniz University Medical Hospital - 2606
Antalya, Turkey (Türkiye)
Trakya University Faculty of Medicine Edirne - 2608
Edirne, Turkey (Türkiye)
Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
Fatih, Turkey (Türkiye)
Koc Universitesi - 2611
Istanbul, Turkey (Türkiye)
Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
Istanbul, Turkey (Türkiye)
Istanbul Bakirkoy Sadi Konuk - 2604
Istanbul, Turkey (Türkiye)
Medipol University Medical Faculty Hospital - 2603
Istanbul, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
Izmir, Turkey (Türkiye)
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
Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803
London, England, United Kingdom
South Tees Hospitals - 2807
Middlesbrough, England, United Kingdom
Torbay and South Devon NHS Foundation Trust - 2805
Torquay, England, United Kingdom
The Christie NHS Foundation Trust - 2802
Manchester, London, United Kingdom
Edinburgh Cancer Centre - 2809
Edinburgh, Scotland, United Kingdom
University College London Hospital - 2811
London, United Kingdom
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
OncoC4, Inc.
Collaborators: BioNTech SE
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Scientific Literature & Publications
  • Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.PubMed ↗
  • Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.PubMed ↗
  • Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27.PubMed ↗
View Official Medical/Scientific Title

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