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

January 17, 2024 updated by: OncoC4, Inc.

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 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

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Recruiting
        • Bankstown Hospital - 3305
      • New Lambton Heights, New South Wales, Australia
        • Recruiting
        • Newcastle Private Hospital - 3302
    • Queensland
      • Newstead, Queensland, Australia, 4006
        • Recruiting
        • Mater - 3301
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research SA - 3303
  • Belgium
      • Gent, Belgium, 9000
        • Not yet recruiting
        • AZ Maria Middelares - 2104
        • Principal Investigator:
          • Paul Germonpre, MD, PhD
      • Hasselt, Belgium, 3500
        • Not yet recruiting
        • Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
        • Principal Investigator:
          • Kristof Cuppens, MD, MSc
      • Liège, Belgium, 4000
        • Not yet recruiting
        • C. H. R. de la Citadelle - 2103
        • Principal Investigator:
          • Frederique Bustin, MD
      • Sint-Niklaas, Belgium, 9100
        • Not yet recruiting
        • Vitaz - Sint-niklaas Moerland - 2101
        • Principal Investigator:
          • Koenraad Deschepper, MD
  • Canada
      • Québec, Canada, H1T1P7
        • Not yet recruiting
        • Santa Cabrini Hospital - 1204
        • Principal Investigator:
          • Michael Palumbo, MD
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Not yet recruiting
        • BC Cancer Centre - Kelowna - 1203
        • Principal Investigator:
          • Guillermo Martos, MD
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Not yet recruiting
        • Saskatchewan Cancer Agency - Regina - 1201
        • Principal Investigator:
          • Mussawar Iqbal, MD
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Not yet recruiting
        • Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
        • Principal Investigator:
          • Sunil Yadav, MD
  • China
      • Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital - 3236
        • Principal Investigator:
          • Yingying Xu, MD
      • Chengdu, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University - 3238
        • Principal Investigator:
          • Yongsheng Wang, MD
      • Jiangse, China, 21006
        • Not yet recruiting
        • Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
        • Principal Investigator:
          • Surong Fang, MD
      • Shandong, China, 261041
        • Not yet recruiting
        • Weifang Second People's Hospital - 3235
        • Principal Investigator:
          • Kunning Yang, MD
      • Shanghai, China, 200120
        • Not yet recruiting
        • Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
        • Principal Investigator:
          • Xuemei Zhang, MD
      • Wuhan, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital - 3237
        • Principal Investigator:
          • Bin Yang, MD
    • Anhui
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University - 3221
        • Principal Investigator:
          • Kangsheng Gu, MD
      • Hefei, Anhui, China, 231200
        • Not yet recruiting
        • Anhui Medical University - The Second Hospital - 3222
        • Principal Investigator:
          • Hui Zhao, MD
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Cancer Hospital - 3205
        • Principal Investigator:
          • Jian Fang, MD
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences - 3211
        • Principal Investigator:
          • Puyuan Xing, MD
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Medical University Union Hospital - 3225
        • Principal Investigator:
          • Xiaoyan Lin, MD
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University - 3210
        • Principal Investigator:
          • Jingxun Wu, MD
    • Guangdong
      • Dongguan, Guangdong, China
        • Recruiting
        • Dongguan People's Hospital - 3206
        • Principal Investigator:
          • Zhigang Liu, MD
      • Guangzhou, Guangdong, China, 510280
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University - 3203
        • Principal Investigator:
          • Jian Zhang, MD
      • Guangzhou, Guangdong, China, 510105
        • Recruiting
        • Guangdong Provincial People's Hospital - 3201
        • Principal Investigator:
          • Huajun Chen, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
        • Principal Investigator:
          • Yanrong Hao, MD
    • Hainan
      • Haikou, Hainan, China
        • Not yet recruiting
        • Hainan General Hospital - 3202
        • Principal Investigator:
          • Xicheng Wang, MD
    • Hebei
      • Zhengzhou, Hebei, China, 71000
        • Recruiting
        • Affiliated Hospital of Hebei University - 3214
        • Principal Investigator:
          • Zizheng Song, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Not yet recruiting
        • The Affiliated Tumor Hospital of Harbin Medical University - 3232
        • Principal Investigator:
          • Yan Yu, MD
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The First Affliated Hospital of Zhengzhou University - 3207
        • Principal Investigator:
          • Xingya Li, MD
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital - 3226
        • Principal Investigator:
          • Qiming Wang, MD
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital Tongji Medical College - 3212
        • Principal Investigator:
          • Xiaorong Dong, MD
      • Wuhan, Hubei, China
        • Recruiting
        • Renmin Hospital of Wuhan University - 3216
        • Principal Investigator:
          • Ximing Xu, MD
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital - 3209
        • Principal Investigator:
          • Lin Wu, MD
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital, Central South University - 3223
        • Principal Investigator:
          • Pinhua Pan, MD
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University - 3217
        • Principal Investigator:
          • Zhixiang Zhang, MD
      • Xuzhou, Jiangsu, China, 221002
        • Not yet recruiting
        • Xuzhou Medical University - The Affiliated Hospital - 3234
        • Principal Investigator:
          • Bi Chen, MD
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University - 3224
        • Principal Investigator:
          • Anwen Liu, MD
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital - 3230
        • Principal Investigator:
          • Meili Sun, MD
    • Shanxi
      • Taiyuan, Shanxi, China, 30032
        • Not yet recruiting
        • Shanxi Bethune Hospital - 3233
        • Principal Investigator:
          • Huijing Feng, MD
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University - 3218
        • Principal Investigator:
          • Hong Sun, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Chengdu Seventh People's Hospital - 3229
        • Principal Investigator:
          • Jiliang Zhang, MD
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital - 3227
        • Principal Investigator:
          • Juan Li, MD
      • Chongqing, Sichuan, China
        • Not yet recruiting
        • Chongqing University Cancer Hospital - 3213
        • Principal Investigator:
          • Luchun Li, MD
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital - 3208
        • Principal Investigator:
          • Xinwei Zhang, MD
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Not yet recruiting
        • Yunnan Cancer Hospital - 3231
        • Principal Investigator:
          • Runxiang Yang, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
        • Principal Investigator:
          • Hongming Pan, MD
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
        • Principal Investigator:
          • Wen Li, MD
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Cancer Hospital - 3204
        • Principal Investigator:
          • Xinmin Yu, MD
  • France
      • Billancourt, France, 92100
        • Not yet recruiting
        • Hôpital Ambroise Paré - 2501
        • Principal Investigator:
          • Etienne Giroux Leprieur, MD
      • Créteil, France, 94000
        • Not yet recruiting
        • Centre Hospitalier Intercommunal de Créteil - 2502
        • Principal Investigator:
          • Christos Chouaid, MD
      • Limoges, France
        • Not yet recruiting
        • CHU Limoges - Hospital du Cluzeau - 2503
        • Principal Investigator:
          • Alain Vergnenegre, MD
  • Germany
      • Bogenhausen, Germany, 81925
        • Not yet recruiting
        • Städt. Klinikum München GmbH - 2204
        • Principal Investigator:
          • Konrad Kokowski, MD
      • Essen, Germany, 45136
        • Not yet recruiting
        • Kliniken Essen-Mitte - 2206
        • Principal Investigator:
          • Daniel Christoph, MD
      • Esslingen am Neckar, Germany, 73730
        • Not yet recruiting
        • Klinikum Esslingen GmbH - 2201
        • Principal Investigator:
          • Martin Faehling, MD, MSc
      • Immenhausen, Germany, 34376
        • Not yet recruiting
        • Lungenfachklinik Immenhausen - 2202
        • Principal Investigator:
          • Achim Rittmeyer, MD
      • Immenstädt, Germany, 87509
        • Not yet recruiting
        • Klinikverbund Allgaü - Klinikum Kempten - 2205
        • Principal Investigator:
          • Christian Schumann, MD, PhD
      • Muenchen-Gauting, Germany, 82131
        • Not yet recruiting
        • Asklepios Fachkliniken Muenchen-Gauting - 2203
        • Principal Investigator:
          • Niels Reinmuth, MD, PhD
  • Italy
      • Ancona, Italy, 60126
        • Not yet recruiting
        • Clinica Oncologica Ospedali Riuniti Ancona - 2311
        • Principal Investigator:
          • Rossana Berardi, MD
      • Bari, Italy, 70124
        • Not yet recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II - 2306
        • Principal Investigator:
          • Domenico Galetta, MD, PhD
      • Bergamo, Italy, 24126
        • Not yet recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
        • Principal Investigator:
          • Anna Cecilia Bettini, MD
      • Messina, Italy, 98158
        • Not yet recruiting
        • Azienda Ospedaliera Papardo - 2301
        • Principal Investigator:
          • Alessandro Russo, MD, PhD
      • Milano, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele - 2307
        • Principal Investigator:
          • Alessandra Bulotta, MD
      • Milano, Italy, 20133
        • Not yet recruiting
        • Fondazione IRCCS Instituto Tumori Di Milano - 2305
        • Principal Investigator:
          • Giuseppe Lo Russo, MD, PhD
      • Monza, Italy, 20900
        • Not yet recruiting
        • Ospedale San Gerardo di Monza - 2302
        • Principal Investigator:
          • Diego Cortinovis, MD
      • Naples, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria "Federico II" - 2304
        • Principal Investigator:
          • Alberto Servetto, MD, PhD
      • Palermo, Italy, 90129
        • Not yet recruiting
        • AOU Policlinico Giaccone, Università di Palermo - 2309
        • Principal Investigator:
          • Valerio Gristina, MD, PhD
      • Perugia, Italy, 06132
        • Not yet recruiting
        • Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
        • Principal Investigator:
          • Rita Chiari, MD
      • Roma, Italy, 00128
        • Not yet recruiting
        • Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
        • Principal Investigator:
          • Alessio Cortellini, MD, PhD
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Not yet recruiting
        • Chungbuk National University Hospital - 3101
        • Principal Investigator:
          • Ki Hyeong Lee, MD, PhD
      • Daegu, Korea, Republic of, 42601
        • Not yet recruiting
        • Keimyung University Dongsan Hospital - 3102
        • Principal Investigator:
          • Keon Uk Park, MD
      • Goyang-si, Korea, Republic of, 10408
        • Not yet recruiting
        • National Cancer Center - 3107
        • Principal Investigator:
          • Young Joo Lee, MD, MMM
      • Seoul, Korea, Republic of, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System - 3104
        • Principal Investigator:
          • Byoung Chul Cho, MD
      • Seoul, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medical Centre - 3103
        • Principal Investigator:
          • Sang-We Kim, MD
      • Seoul, Korea, Republic of, 08308
        • Not yet recruiting
        • Korea University Guro Hospital - 3106
        • Principal Investigator:
          • Eun Joo Kang, MD
      • Suwon, Korea, Republic of, 16247
        • Not yet recruiting
        • The Catholic University of Korea, St Vincent's Hospital - 3105
        • Principal Investigator:
          • Byoung Yong Shim, MD
  • Netherlands
      • Amsterdam, Netherlands, 1066 CV
        • Not yet recruiting
        • Antoni van Leeuwenhoek - 2703
        • Principal Investigator:
          • Willemijn Theelen, MD
      • Arnhem, Netherlands, 6815
        • Not yet recruiting
        • Rijnstate Ziekenhuis - 2701
        • Principal Investigator:
          • Niels Claessens, MD
      • Herzogenbusch, Netherlands, 5223
        • Not yet recruiting
        • Jeroen Bosch Ziekenhuis - 2702
        • Principal Investigator:
          • Bianca Van Veggel, MD
      • Tilburg, Netherlands, 5022 GC
        • Not yet recruiting
        • ETZ Elisabeth - 2704
        • Principal Investigator:
          • Helen Kloover, MD
  • Spain
      • Elche, Spain, 03203
        • Not yet recruiting
        • Hospital General Universitario de Elche - 2401
        • Principal Investigator:
          • Maria Guirado Risueño, MD
      • Lugo, Spain, 27003
        • Not yet recruiting
        • Hospital Universitario Lucus Augusti - 2405
        • Principal Investigator:
          • Sergio Vazquez Estevez, MD
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañon - 2404
        • Principal Investigator:
          • Antonio Calles Blanco, MD
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Regional Universitario de Malaga - 2403
        • Principal Investigator:
          • Manuel Cobo Dols, MD, PhD
      • Valencia, Spain, 46014
        • Not yet recruiting
        • Hospital General Universitario de Valencia - 2406
        • Principal Investigator:
          • Ana Blasco Cordellat, MD
      • Valencia, Spain, 56009
        • Not yet recruiting
        • Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
        • Principal Investigator:
          • Ignacio Gil-Bazo, MD, PhD
  • Turkey
      • Adana, Turkey
        • Not yet recruiting
        • Adana Sehir Hastanesi - 2602
        • Principal Investigator:
          • Timucin Cil, MD
      • Adana, Turkey
        • Not yet recruiting
        • Baskent University Adana - 2601
        • Principal Investigator:
          • Fatih Kose, MD
      • Ankara, Turkey, 06230
        • Not yet recruiting
        • Hacettepe Universitesi - 2609
        • Principal Investigator:
          • Mustafa Erman, MD
      • Ankara, Turkey, 06800
        • Not yet recruiting
        • Ankara Bilkent Sehir Hastanesi - 2610
        • Principal Investigator:
          • Mehmet Ali nahit Sendur, MD
      • Antalya, Turkey
        • Not yet recruiting
        • Akdeniz University Medical Hospital - 2606
        • Principal Investigator:
          • Sema Sezgin Goksu, MD
      • Bornova, Turkey, 35100
        • Not yet recruiting
        • Ege Universitesi Hastanesi - 2612
        • Principal Investigator:
          • Erdem Goker, MD
      • Edirne, Turkey
        • Not yet recruiting
        • Trakya University Faculty of Medicine Edirne - 2608
        • Principal Investigator:
          • Bulent Erdogan, MD
      • Fatih, Turkey, 34093
        • Not yet recruiting
        • Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
        • Principal Investigator:
          • Pinar Saip, MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
        • Principal Investigator:
          • Mahmut Gumus, MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul Bakirkoy Sadi Konuk - 2604
        • Principal Investigator:
          • Deniz Tural, MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Medipol University Medical Faculty Hospital - 2603
        • Principal Investigator:
          • Ahmet Bilici, MD
      • Istanbul, Turkey, 34010
        • Not yet recruiting
        • Koc Universitesi - 2611
        • Principal Investigator:
          • Fatih Selcukbiricik, MD
      • İzmir, Turkey
        • Not yet recruiting
        • Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
        • Principal Investigator:
          • Cagatay Arslan, MD
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TG
        • Not yet recruiting
        • University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
        • Principal Investigator:
          • Gary Middleton, MD
      • Cambridge, England, United Kingdom, CB2 0QQ
        • Not yet 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
        • Not yet recruiting
        • University Hospital Leicester - 2806
        • Principal Investigator:
          • Sean Dulloo, MRCP, MSc
      • London, England, United Kingdom, EC1A 7BE
        • Not yet recruiting
        • The Christie NHS Foundation Trust - 2803
        • Principal Investigator:
          • Fabio Gomes, MD, MRes
      • Manchester, England, United Kingdom, M20 4BX
        • Not yet recruiting
        • Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802
        • Principal Investigator:
          • Farah Louise Lim, MRCP
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • Not yet recruiting
        • South Tees Hospitals - 2807
        • Principal Investigator:
          • Talal Mansy, MD
      • Southampton, England, United Kingdom, SO16 6YD
        • Not yet recruiting
        • University Hospital Southampton - 2810
        • Principal Investigator:
          • Luke Nolan, MD
      • Torquay, England, United Kingdom, TQ2 7AA
        • Not yet recruiting
        • Torbay Hospital - Horizon Centre - 2805
        • Principal Investigator:
          • Louise / Jonathan Medley / Buckley, MD
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Not yet 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
        • Not yet 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
      • Chula Vista, California, United States, 91911
        • Not yet recruiting
        • Sharp Healthcare - 1150
        • Principal Investigator:
          • Kenneth Johnson, MD
      • Redlands, California, United States, 92373
        • Not yet 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
        • Not yet recruiting
        • Bass Medical Group - 1155
        • Principal Investigator:
          • Tyler Kang, MD
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Not yet recruiting
        • University of Connecticut - 1111
        • Principal Investigator:
          • Susan Tannenbaum, MD
      • Norwalk, Connecticut, United States, 06850
        • Recruiting
        • Nuvance Health - 1118
        • Principal Investigator:
          • Richard Frank, MD
    • Florida
      • Margate, Florida, United States, 33063
        • Not yet 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
        • Not yet recruiting
        • Florida Cancer Specialists -South - 1126
        • Principal Investigator:
          • Fadi Kayali, MD
      • The Villages, Florida, United States, 32159
        • Not yet recruiting
        • Florida Cancer Specialists -North - 1125
        • Principal Investigator:
          • Adewale Fawole, MD
      • West Palm Beach, Florida, United States, 33401
        • Not yet 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
        • Not yet recruiting
        • Deaconess Chancellor Center for Oncology - 1131
        • Principal Investigator:
          • Yasoda Devabhaktuni, MD
    • Kansas
      • Merriam, Kansas, United States, 66204
        • Recruiting
        • Alliance for Multispecialty Research, LLC - 1144
        • Principal Investigator:
          • Jaswinder Singh, MD
      • Topeka, Kansas, United States, 66606
        • Not yet 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
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Hematology Oncology Clinics - Baton Rouge - 1142
        • Principal Investigator:
          • Christopher McCanless, MD
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Not yet recruiting
        • HealthPartners Institute, Cancer Research Center - 1143
        • Principal Investigator:
          • Dylan Zylla, MD, MS
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Jefferson City Medical Group - 1145
        • Principal Investigator:
          • Shadi Haddadin, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Not yet recruiting
        • NHO-Revive Research Institute, LLC - 1152
        • Principal Investigator:
          • Kailash Mosalpuria, MD
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care - 1128
        • Principal Investigator:
          • Bruno Fang, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Not yet recruiting
        • Messino Cancer Centers - 1121
        • Principal Investigator:
          • Andrew Beardsley, MD
    • Ohio
      • 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
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital - 1115
        • Principal Investigator:
          • Tarek Sabagh, MD
      • Massillon, Ohio, United States, 44646
        • Not yet recruiting
        • Tri County Hematology & Oncology Associates, Inc - 1156
        • Principal Investigator:
          • Nagaprasad Nagajothi, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Not yet recruiting
        • Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) - 1154
        • Principal Investigator:
          • Byron Jennings, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Not yet recruiting
        • Oncology Associates of Oregon - 1138
        • Principal Investigator:
          • Bo Wang, MD
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Pennsylvania Cancer Specialists Research Institute - 1101
        • Principal Investigator:
          • Satish Shah, MD
      • 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
        • Not yet recruiting
        • Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
        • Principal Investigator:
          • Melissa Johnson, MD
    • Texas
      • Dallas, Texas, United States, 75230
        • Not yet recruiting
        • Texas Oncology -Dallas - 1127
        • Principal Investigator:
          • Jay Courtright, MD
      • Denison, Texas, United States, 75020
        • Not yet recruiting
        • Texas Oncology - Denison - 1139
        • Principal Investigator:
          • Amir Faridi, MD
      • Fort Worth, Texas, United States, 76105
        • Not yet recruiting
        • Texas Oncology - Fort Worth Cancer Center - 1141
        • Principal Investigator:
          • Rahel Theriault, MD
      • Houston, Texas, United States, 77024
        • Recruiting
        • Oncology Consultants, P.A. - 1120
        • Principal Investigator:
          • Julio Peguero, MD
      • McAllen, Texas, United States, 78503
        • Not yet recruiting
        • Texas Oncology - McAllen - 1132
        • Principal Investigator:
          • Habib Ghaddar, MD, FACP
      • Plano, Texas, United States, 75093
        • Not yet recruiting
        • Texas Oncology - Plano West - 1137
        • Principal Investigator:
          • Philip Kovoor, MD
      • San Antonio, Texas, United States, 78240
        • Not yet recruiting
        • Texas Oncology -San Antonio - 1122
        • Principal Investigator:
          • Krishna Alluri, MD
      • Tyler, Texas, United States, 75702
        • Not yet recruiting
        • Texas Oncology - Northeast Texas - Tyler - 1134
        • Principal Investigator:
          • Donald Richards, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet 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
        • Not yet recruiting
        • Virginia Oncology Associates - 1136
        • Principal Investigator:
          • John Paschold, MD
    • Washington
      • Spokane, Washington, United States, 99218
        • Not yet recruiting
        • MultiCare Institute for Research and Innovation - Tacoma - 1148
        • Principal Investigator:
          • Jay Wittenkeller, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 3: 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
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
Experimental: Arm 2: Gotistobart 3 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

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 (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESERVE-003

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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