ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)
Non Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria (Major criteria): Adult (≥ 18 years), all genders, capable of signing informed consent. Histologically- or cytologically- confirmed diagnosis of metastatic 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. Exclusion Criteria (Major criteria): 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.
Sites / Locations
- XCancer/Dothan Hematology & Oncology - 1114Recruiting
- Genesis Cancer and Blood Institute - 1123
- The Oncology Institute (TOI) Clinical Research - 1109Recruiting
- Sharp Healthcare - 1150
- University of California at Davis - 1103Recruiting
- Emad Ibrahim MD Inc. - 1147
- University of Connecticut - 1111
- Nuvance Health - 1118Recruiting
- Ocala Oncology Center PL - 1102Recruiting
- AdventHealth Cancer Institute - 1105Recruiting
- Orlando Health - 1130
- Florida Cancer Specialists -South - 1126
- Florida Cancer Specialists -North - 1125
- Florida Cancer Specialists -East - 1124
- Orchard Healthcare Research, Inc. - 1116Recruiting
- Springfield Clinic - The Cancer Center - 1110Recruiting
- Fort Wayne Medical Oncology - 1133
- Deaconess Chancellor Center for Oncology - 1131
- Alliance for Multispecialty Research, LLC - 1144
- University of Kentucky - Markey Cancer Center - 1112
- Norton Cancer Institute - 1108Recruiting
- Hematology Oncology Clinics - Baton Rouge - 1142
- HealthPartners Institute, Cancer Research Center - 1143
- Jefferson City Medical Group - 1145
- Astera Cancer Care - 1128Recruiting
- Messino Cancer Centers - 1121
- University of Cincinnati Cancer Center - 1107
- The Ohio State University James Cancer Center - 1104Recruiting
- Miami Valley Hospital - 1115Recruiting
- Oncology Associates of Oregon - 1138
- Pennsylvania Cancer Specialists Research Institute - 1101Recruiting
- Donald Guthrie Foundation - 1135
- Cancer Care Associates of York, Inc. - 1113Recruiting
- University of Tennessee Medical Center - 1146
- Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119Recruiting
- Texas Oncology -Dallas - 1127
- Texas Oncology - Denison - 1139
- Texas Oncology - Fort Worth Cancer Center - 1141
- Oncology Consultants, P.A. - 1120Recruiting
- Texas Oncology - McAllen - 1132
- Texas Oncology - Plano West - 1137
- Texas Oncology -San Antonio - 1122
- Texas Oncology - Northeast Texas - Tyler - 1134
- NEXT Oncology - Virginia - 1129
- Virginia Cancer Institute - 1149
- Virginia Oncology Associates - 1136
- MultiCare Institute for Research and Innovation - Tacoma - 1148
- Bankstown Hospital - 3305
- Newcastle Private Hospital - 3302
- Mater - 3301
- Cancer Research SA - 3303
- AZ Maria Middelares - 2104
- Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
- C. H. R. de la Citadelle - 2103
- Vitaz - Sint-niklaas Moerland - 2101
- BC Cancer Centre - Kelowna - 1203
- Saskatchewan Cancer Agency - Regina - 1201
- Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
- The First Affiliated Hospital of Anhui Medical University - 3221
- Anhui Medical University - The Second Hospital - 3222
- Beijing Cancer Hospital - 3205
- Cancer Hospital, Chinese Academy of Medical Sciences - 3211
- Fujian Medical University Union Hospital - 3225
- The First Affiliated Hospital of Xiamen University - 3210
- Dongguan People's Hospital - 3206
- Guangdong Provincial People's Hospital - 3201Recruiting
- Zhujiang Hospital of Southern Medical University - 3203
- The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
- The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
- Hainan General Hospital - 3202
- Affiliated Hospital of Hebei University - 3214
- The Affiliated Tumor Hospital of Harbin Medical University - 3232
- Henan Cancer Hospital - 3226
- The First Affliated Hospital of Zhengzhou University - 3207
- Renmin Hospital of Wuhan University - 3216
- Union Hospital Tongji Medical College - 3212
- Xiangya Hospital, Central South University - 3223
- Hunan Cancer Hospital - 3209
- The Second Affiliated Hospital of Soochow University - 3217
- Xuzhou Medical University - The Affiliated Hospital - 3234
- The Second Affiliated Hospital of Nanchang University - 3224
- Jinan Central Hospital - 3230
- Shanxi Bethune Hospital - 3233
- The First Affiliated Hospital of Xi'an Jiaotong University - 3218
- Chengdu Seventh People's Hospital - 3229
- Sichuan Cancer Hospital - 3227
- Chongqing University Cancer Hospital - 3213
- Tianjin Medical University Cancer Institute and Hospital - 3208
- Yunnan Cancer Hospital - 3231
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
- The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
- Zhejiang Cancer Hospital - 3204
- Hôpital Ambroise Paré - 2501
- Centre Hospitalier Intercommunal de Créteil - 2502
- CHU Limoges - Hospital du Cluzeau - 2503
- Städt. Klinikum München GmbH - 2204
- Kliniken Essen-Mitte - 2206
- Klinikum Esslingen GmbH - 2201
- Lungenfachklinik Immenhausen - 2202
- Klinikverbund Allgaü - Klinikum Kempten - 2205
- Asklepios Fachkliniken Muenchen-Gauting - 2203
- Clinica Oncologica Ospedali Riuniti Ancona - 2311
- IRCCS Istituto Tumori Giovanni Paolo II - 2306
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
- Azienda Ospedaliera Papardo - 2301
- Ospedale San Raffaele - 2307
- Fondazione IRCCS Instituto Tumori Di Milano - 2305
- Ospedale San Gerardo di Monza - 2302
- Azienda Ospedaliera Universitaria "Federico II" - 2304
- AOU Policlinico Giaccone, Università di Palermo - 2309
- Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
- Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
- Chungbuk National University Hospital - 3101
- Keimyung University Dongsan Hospital - 3102
- National Cancer Center - 3107
- Severance Hospital, Yonsei University Health System - 3104
- Asan Medical Centre - 3103
- Korea University Guro Hospital - 3106
- The Catholic University of Korea, St Vincent's Hospital - 3105
- Rijnstate Ziekenhuis - 2701
- Jeroen Bosch Ziekenhuis - 2702
- Hospital General Universitario de Elche - 2401
- Hospital Universitario Lucus Augusti - 2405
- Hospital General Universitario Gregorio Marañon - 2404
- Hospital Regional Universitario de Malaga - 2403
- Hospital General Universitario de Valencia - 2406
- Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
- Adana Sehir Hastanesi - 2602
- Baskent University Adana - 2601
- Hacettepe Universitesi - 2609
- Ankara Bilkent Sehir Hastanesi - 2610
- Akdeniz University Medical Hospital - 2606
- Trakya University Faculty of Medicine Edirne - 2608
- Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
- Istanbul Bakirkoy Sadi Konuk - 2604
- Medipol University Medical Faculty Hospital - 2603
- Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
- University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
- Cambridge University Hospitals - 2804
- University Hospital Leicester - 2806
- The Christie NHS Foundation Trust - 2803
- Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802
- Torbay Hospital - Horizon Centre - 2805
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W
Arm 2: Gotistobart 3 mg/kg Q3W
Arm 3: Docetaxel 75 mg/m2, Q3W
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.