ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Gotistobart

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 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 Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pan Zheng, MD, PhD; Phone Number: 2027516823; Email: pzheng@oncoc4.com

Study Locations

• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Not yet recruiting
      • Bankstown Hospital - 3305
  • Queensland
    • Newstead, Queensland, Australia, 4006
      • Not yet recruiting
      • Mater - 3301
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Completed
      • Cancer Research SA - 3303
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Not yet recruiting
      • Western Health - Sunshine Hospital - 3307
      • Principal Investigator: Suzanne Kosmider, MD
• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares - 2104
    • Principal Investigator: Paul Germonpre, MD, PhD
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
    • Principal Investigator: Kristof Cuppens, MD, MSc
  • Liège, Belgium, 4000
    • Recruiting
    • C. H. R. de la Citadelle - 2103
    • Principal Investigator: Frederique Bustin, MD
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • Vitaz - Sint-niklaas Moerland - 2101
    • Principal Investigator: Koenraad Deschepper, MD
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
      • Recruiting
      • BC Cancer Centre - Kelowna - 1203
      • Principal Investigator: Guillermo Martos, MD
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Saskatchewan Cancer Agency - Regina - 1201
      • Principal Investigator: Mussawar Iqbal, MD
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Recruiting
      • Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
      • Principal Investigator: Sunil Yadav, MD
• China
  • Beijing, China, 100029
    • Completed
    • China-Japan Friendship Hospital - 3236
  • Chengdu, China, 610041
    • Completed
    • West China Hospital, Sichuan University - 3238
  • Jiangse, China, 21006
    • Completed
    • Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
  • Shandong, China, 261041
    • Completed
    • Weifang Second People's Hospital - 3235
  • Shanghai, China, 200120
    • Completed
    • Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
  • Wuhan, China, 430079
    • Completed
    • Hubei Cancer Hospital - 3237
  • Anhui
    • Hefei, Anhui, China, 230022
      • Completed
      • The First Affiliated Hospital of Anhui Medical University - 3221
    • Hefei, Anhui, China, 231200
      • Completed
      • Anhui Medical University - The Second Hospital - 3222
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Completed
      • Beijing Cancer Hospital - 3205
    • Beijing, Beijing Municipality, China
      • Completed
      • Cancer Hospital, Chinese Academy of Medical Sciences - 3211
  • Fujian
    • Fuzhou, Fujian, China
      • Completed
      • Fujian Medical University Union Hospital - 3225
    • Xiamen, Fujian, China
      • Completed
      • The First Affiliated Hospital of Xiamen University - 3210
  • Guangdong
    • Dongguan, Guangdong, China
      • Completed
      • Dongguan People's Hospital - 3206
    • Guangzhou, Guangdong, China, 510105
      • Completed
      • Guangdong Provincial People's Hospital - 3201
    • Guangzhou, Guangdong, China, 510280
      • Completed
      • Zhujiang Hospital of Southern Medical University - 3203
    • Guangzhou, Guangdong, China
      • Completed
      • The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Completed
      • The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
  • Hainan
    • Haikou, Hainan, China
      • Completed
      • Hainan General Hospital - 3202
  • Hebei
    • Zhengzhou, Hebei, China, 71000
      • Completed
      • Affiliated Hospital of Hebei University - 3214
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Completed
      • The Affiliated Tumor Hospital of Harbin Medical University - 3232
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Completed
      • Henan Cancer Hospital - 3226
    • Zhengzhou, Henan, China
      • Completed
      • The First Affliated Hospital of Zhengzhou University - 3207
  • Hubei
    • Wuhan, Hubei, China
      • Completed
      • Renmin Hospital of Wuhan University - 3216
    • Wuhan, Hubei, China
      • Completed
      • Union Hospital Tongji Medical College - 3212
  • Hunan
    • Changsha, Hunan, China, 410008
      • Completed
      • Xiangya Hospital, Central South University - 3223
    • Changsha, Hunan, China
      • Completed
      • Hunan Cancer Hospital - 3209
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Completed
      • The Second Affiliated Hospital of Soochow University - 3217
    • Xuzhou, Jiangsu, China, 221002
      • Completed
      • Xuzhou Medical University - The Affiliated Hospital - 3234
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Completed
      • The Second Affiliated Hospital of Nanchang University - 3224
  • Shandong
    • Jinan, Shandong, China, 250013
      • Completed
      • Jinan Central Hospital - 3230
  • Shanxi
    • Taiyuan, Shanxi, China, 30032
      • Completed
      • Shanxi Bethune Hospital - 3233
    • Xi’an, Shanxi, China
      • Completed
      • The First Affiliated Hospital of Xi'an Jiaotong University - 3218
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Completed
      • Chengdu Seventh People's Hospital - 3229
    • Chengdu, Sichuan, China, 610041
      • Completed
      • Sichuan Cancer Hospital - 3227
    • Chongqing, Sichuan, China
      • Completed
      • Chongqing University Cancer Hospital - 3213
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Completed
      • Tianjin Medical University Cancer Institute and Hospital - 3208
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Completed
      • Yunnan Cancer Hospital - 3231
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Completed
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
    • Hangzhou, Zhejiang, China
      • Completed
      • The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
    • Hangzhou, Zhejiang, China
      • Completed
      • Zhejiang Cancer Hospital - 3204
• Germany
  • Bogenhausen, Germany, 81925
    • Recruiting
    • Städt. Klinikum München GmbH - 2204
    • Principal Investigator: Konrad Kokowski, MD
  • Essen, Germany, 45136
    • Recruiting
    • Kliniken Essen-Mitte - 2206
    • Principal Investigator: Daniel Christoph, MD
  • Esslingen am Neckar, Germany, 73730
    • Recruiting
    • Klinikum Esslingen GmbH - 2201
    • Principal Investigator: Martin Faehling, MD, MSc
  • Immenhausen, Germany, 34376
    • Recruiting
    • Lungenfachklinik Immenhausen - 2202
    • Principal Investigator: Achim Rittmeyer, MD
  • Immenstädt, Germany, 87509
    • Recruiting
    • Klinikverbund Allgaü - Klinikum Kempten - 2205
    • Principal Investigator: Christian Schumann, MD, PhD
  • Muenchen-Gauting, Germany, 82131
    • Recruiting
    • Asklepios Fachkliniken Muenchen-Gauting - 2203
    • Principal Investigator: Niels Reinmuth, MD, PhD
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Clinica Oncologica Ospedali Riuniti Ancona - 2311
    • Principal Investigator: Rossana Berardi, MD
  • Bari, Italy, 70124
    • Recruiting
    • IRCCS Istituto Tumori Giovanni Paolo II - 2306
    • Principal Investigator: Domenico Galetta, MD, PhD
  • Bergamo, Italy, 24126
    • Recruiting
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
    • Principal Investigator: Anna Cecilia Bettini, MD
  • Catania, Italy, 95045
    • Recruiting
    • Humanitas Istituto Clinico Catanese - 2312
    • Principal Investigator: Alessandro Russo, MD
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele - 2307
    • Principal Investigator: Alessandra Bulotta, MD
  • Milan, Italy, 20133
    • Not yet recruiting
    • Fondazione IRCCS Instituto Tumori Di Milano - 2305
    • Principal Investigator: Giuseppe Lo Russo, MD, PhD
  • Monza, Italy, 20900
    • Recruiting
    • Ospedale San Gerardo di Monza - 2302
    • Principal Investigator: Diego Cortinovis, MD
  • Naples, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria "Federico II" - 2304
    • Principal Investigator: Alberto Servetto, MD, PhD
  • Palermo, Italy, 90129
    • Recruiting
    • AOU Policlinico Giaccone, Università di Palermo - 2309
    • Principal Investigator: Valerio Gristina, MD, PhD
  • Perugia, Italy, 06132
    • Recruiting
    • Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
    • Principal Investigator: Rita Chiari, MD
  • Roma, Italy, 00128
    • Recruiting
    • Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
    • Principal Investigator: Alessio Cortellini, MD, PhD
• Netherlands
  • Amsterdam, Netherlands, 1066 CV
    • Recruiting
    • Antoni van Leeuwenhoek - 2703
    • Principal Investigator: Willemijn Theelen, MD
  • Arnhem, Netherlands, 6815
    • Recruiting
    • Rijnstate Ziekenhuis - 2701
    • Principal Investigator: Niels Claessens, MD
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • ETZ Elisabeth - 2704
    • Principal Investigator: Helen Kloover, MD
• South Korea
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Chungbuk National University Hospital - 3101
    • Principal Investigator: Ki Hyeong Lee, MD, PhD
  • Daegu, South Korea, 42601
    • Recruiting
    • Keimyung University Dongsan Hospital - 3102
    • Principal Investigator: Keon Uk Park, MD
  • Goyang-si, South Korea, 10408
    • Recruiting
    • National Cancer Center - 3107
    • Principal Investigator: Young Joo Lee, MD, MMM
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System - 3104
    • Principal Investigator: Byoung Chul Cho, MD
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Centre - 3103
    • Principal Investigator: Sang-We Kim, MD
  • Seoul, South Korea, 08308
    • Recruiting
    • Korea University Guro Hospital - 3106
    • Principal Investigator: Eun Joo Kang, MD
  • Suwon, South Korea, 16247
    • Recruiting
    • The Catholic University of Korea, St Vincent's Hospital - 3105
    • Principal Investigator: Byoung Yong Shim, MD
• Spain
  • Elche, Spain, 03203
    • Recruiting
    • Hospital General Universitario de Elche - 2401
    • Principal Investigator: Maria Guirado Risueno, MD
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Augusti - 2405
    • Principal Investigator: Sergio Vazquez Estevez, MD
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon - 2404
    • Principal Investigator: Antonio Calles Blanco, MD
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Malaga - 2403
    • Principal Investigator: Manuel Cobo Dols, MD, PhD
  • Valencia, Spain, 46014
    • Recruiting
    • Hospital General Universitario de Valencia - 2406
    • Principal Investigator: Ana Blasco Cordellat, MD
  • Valencia, Spain, 56009
    • Recruiting
    • Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
    • Principal Investigator: Ignacio Gil-Bazo, MD, PhD
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Adana Sehir Hastanesi - 2602
    • Principal Investigator: Timuçin Çil, MD
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Baskent University Adana - 2601
    • Principal Investigator: Fatih Kose, MD
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Hacettepe Universitesi - 2609
    • Principal Investigator: Mustafa Erman, MD
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Bilkent Sehir Hastanesi - 2610
    • Principal Investigator: Mehmet Ali nahit Sendur, MD
  • Antalya, Turkey (Türkiye)
    • Recruiting
    • Akdeniz University Medical Hospital - 2606
    • Principal Investigator: Sema Sezgin Goksu, MD
  • Edirne, Turkey (Türkiye)
    • Recruiting
    • Trakya University Faculty of Medicine Edirne - 2608
    • Principal Investigator: Bulent Erdogan, MD
  • Fatih, Turkey (Türkiye), 34093
    • Recruiting
    • Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
    • Principal Investigator: Pinar Saip, MD
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Koc Universitesi - 2611
    • Principal Investigator: Fatih Selcukbiricik, MD
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
    • Principal Investigator: Mahmut Gumus, MD
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istanbul Bakirkoy Sadi Konuk - 2604
    • Principal Investigator: Deniz Tural, MD
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Medipol University Medical Faculty Hospital - 2603
    • Principal Investigator: Ahmet Bilici, MD
  • Izmir, Turkey (Türkiye)
    • Recruiting
    • Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
    • Principal Investigator: Cagatay Arslan, MD
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College London Hospital - 2811
    • Principal Investigator: Siow Ming Lee, MD
  • England
    • Birmingham, England, United Kingdom, B15 2TG
      • Recruiting
      • University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
      • Principal Investigator: Gary Middleton, MD
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Recruiting
      • Cambridge University Hospitals - 2804
      • Principal Investigator: Philip Earwaker, MD
    • Exeter, England, United Kingdom, EX25DW
      • Not yet recruiting
      • Royal Devon University Healthcare NHS - 2808
      • Principal Investigator: Petru Belitei, MD
    • Leicester, England, United Kingdom, LE1 5WW
      • Recruiting
      • University Hospital Leicester - 2806
      • Principal Investigator: Sean Dulloo, MRCP, MSc
    • London, England, United Kingdom, EC1A 7BE
      • Recruiting
      • Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803
      • Principal Investigator: Farah Louise Lim, MRCP
    • Middlesbrough, England, United Kingdom, TS4 3BW
      • Recruiting
      • South Tees Hospitals - 2807
      • Principal Investigator: Talal Mansy, MD
    • Torquay, England, United Kingdom, TQ2 7AA
      • Recruiting
      • Torbay and South Devon NHS Foundation Trust - 2805
      • Principal Investigator: Louise Medley, MD
  • London
    • Manchester, London, United Kingdom, M20 4BX
      • Recruiting
      • The Christie NHS Foundation Trust - 2802
      • Principal Investigator: Fabio Gomes, MD, MRes
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH54 6PP
      • Recruiting
      • Edinburgh Cancer Centre - 2809
      • Principal Investigator: Colin Barrie, MD
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Recruiting
      • XCancer/Dothan Hematology & Oncology - 1114
      • Principal Investigator: Jawaunna Blackmon, MD
  • Arkansas
    • Russellville, Arkansas, United States, 72801
      • Recruiting
      • Genesis Cancer and Blood Institute - 1123
      • Principal Investigator: Timothy Webb, MD
  • California
    • Cerritos, California, United States, 90703
      • Recruiting
      • The Oncology Institute (TOI) Clinical Research - 1109
      • Principal Investigator: Omkar Marathe, MD
    • Redlands, California, United States, 92373
      • Recruiting
      • Emad Ibrahim MD Inc. - 1147
      • Principal Investigator: Emad Ibrahim, MD
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Comprehensive Cancer Center - 1103
      • Principal Investigator: Tianhong Li, MD, PhD
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Bass Medical Group - 1155
      • Principal Investigator: Tyler Kang, MD
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Recruiting
      • Nuvance Health - 1118
      • Principal Investigator: Richard Frank, MD
  • Florida
    • Margate, Florida, United States, 33063
      • Recruiting
      • D&H Cancer Research Center LLC - 1153
      • Principal Investigator: David Kahn, MD
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Ocala Oncology Center PL - 1102
      • Principal Investigator: Rama Balaraman, MD
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Cancer Institute - 1105
      • Principal Investigator: Mark Socinski, MD
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health - 1130
      • Principal Investigator: Tirrell Johnson, MD
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Florida Cancer Specialists -South - 1126
      • Principal Investigator: Fadi Kayali, MD
    • The Villages, Florida, United States, 32159
      • Recruiting
      • Florida Cancer Specialists -North - 1125
      • Principal Investigator: Adewale Fawole, MD
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • Florida Cancer Specialists -East - 1124
      • Principal Investigator: Todd Gersten, MD
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • Orchard Healthcare Research, Inc. - 1116
      • Principal Investigator: Ira Oliff, MD
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Springfield Clinic - The Cancer Center - 1110
      • Principal Investigator: Preet Singh, MD
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Recruiting
      • Fort Wayne Medical Oncology - 1133
      • Principal Investigator: Ahad Sadiq, MD
    • Newburgh, Indiana, United States, 47630
      • Recruiting
      • Deaconess Chancellor Center for Oncology - 1131
      • Principal Investigator: Yasoda Devabhaktuni, MD
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Recruiting
      • Cotton O'Neil Clinical Research Center - 1151
      • Principal Investigator: Mehmood Hashmi, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky - Markey Cancer Center - 1112
      • Principal Investigator: Zhonglin Hao, MD, PhD
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Cancer Institute - 1108
      • Principal Investigator: John Hamm, MD
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Recruiting
      • Jefferson City Medical Group - 1145
      • Principal Investigator: Shadi Haddadin, MD
    • Kansas City, Missouri, United States, 64132
      • Recruiting
      • MidAmerica Cancer Care - 1163
      • Principal Investigator: Jaswinder Singh, MD
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care - 1128
      • Principal Investigator: Bruno Fang, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center - 1158
      • Principal Investigator: Eziafa Oduah, MD, PhD, MPH
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Recruiting
      • Miami Valley Hospital - 1115
      • Principal Investigator: Tarek Sabagh, MD
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Cancer Center - 1107
      • Principal Investigator: Jennifer Leddon, MD, PhD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University James Cancer Center - 1104
      • Principal Investigator: Kai He, MD, PhD
    • Massillon, Ohio, United States, 44646
      • Recruiting
      • Tri County Hematology & Oncology Associates, Inc - 1156
      • Principal Investigator: Nagaprasad Nagajothi, MD
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Recruiting
      • Oklahoma Cancer Specialists and Research Institute - 1154
      • Principal Investigator: Mark Jennings, MD
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Oncology Associates of Oregon - 1138
      • Principal Investigator: Bo Wang, MD
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St. Luke's University Health Network - 1179
      • Principal Investigator: Neil Belman, DO
    • Sayre, Pennsylvania, United States, 18840
      • Recruiting
      • Donald Guthrie Foundation - 1135
      • Principal Investigator: Joyson Poulose, MD
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • Cancer Care Associates of York, Inc. - 1113
      • Principal Investigator: Chanh Huynh, MD
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center - 1146
      • Principal Investigator: Ardalan Davarifar, MD, PhD
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
      • Principal Investigator: Melissa Johnson, MD
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
      • Principal Investigator: Kartik Konduri, MD
    • Denison, Texas, United States, 75020
      • Recruiting
      • Texas Oncology - Denison - 1139
      • Principal Investigator: Amir Faridi, MD
    • Houston, Texas, United States, 77024
      • Recruiting
      • Oncology Consultants, P.A. - 1120
      • Principal Investigator: Julio Peguero, MD
    • Laredo, Texas, United States, 78041
      • Recruiting
      • Oncology and Hematology of South Texas - 1165
      • Principal Investigator: Eduardo Miranda, MD
    • McAllen, Texas, United States, 78503
      • Recruiting
      • Texas Oncology - McAllen - 1132
      • Principal Investigator: Habib Ghaddar, MD, FACP
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • Texas Oncology -San Antonio - 1122
      • Principal Investigator: Krishna Alluri, MD
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology - Virginia - 1129
      • Principal Investigator: Yin Chao, MD
    • Henrico, Virginia, United States, 23226
      • Recruiting
      • Virginia Cancer Institute - 1149
      • Principal Investigator: Rachit Kumar, MD
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates - 1136
      • Principal Investigator: John Paschold, MD
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • West Virginia University Cancer Institute - 1172
      • Principal Investigator: Mohammed Almubarak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Major criteria):

1. Adult (≥ 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.

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

   1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
   2. 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.

4. At least one measurable tumor lesion according to RECIST 1.1.
5. ECOG score of 0 or 1.
6. Adequate organ functions. Serum LDH level ≤ 2xULN.
7. Life expectancy ≥ 3 months.

Exclusion Criteria (Major criteria):

1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
3. Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
4. 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.
5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.
8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
9. Impaired heart function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Gotistobart; Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.; Other Names: A humanized anti-CTLA4 IgG1 monoclonal antibody; ONC-392; BNT316
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.	Drug: Docetaxel; Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.; Other Names: Taxotere; Docefrez

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1	36 months
Objective response rate (ORR)	Objective response rate (ORR) as assessed by the Investigator per RECIST 1.1	36 months
Treatment emergent adverse events, treatment related adverse events and immune related adverse events.	Incidence of TEAEs, TRAEs, irAEs will be calculated. The AEs leading to treatment discontinuation will be recorded.	36 months

Collaborators and Investigators

• Sponsor: OncoC4, Inc.
• Collaborators: BioNTech SE
• Investigators: Principal Investigator: Mark Socinski, MD, Advent Health System; Principal Investigator: Tianhong Li, MD, PhD, University of California, Davis; Principal Investigator: Kai He, MD, PhD, Ohio State University

Publications and helpful links

General 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.
• 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.
• 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 Mar 27. doi: 10.1038/s41591-026-04323-8. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: December 31, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: PRESERVE-003; 2023-505311-20-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No