RECRUITING

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

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Conditions

Non Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-06-28
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05671510

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Pan Zheng, MD, PhD
CONTACT
2027516823
pzheng@oncoc4.com

Principal Investigator

Mark Socinski, MD
PRINCIPAL_INVESTIGATOR
Advent Health System
Tianhong Li, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis
Kai He, MD, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

XCancer/Dothan Hematology & Oncology - 1114
Dothan, Alabama, 36303
United States
Genesis Cancer and Blood Institute - 1123
Russellville, Arkansas, 72801
United States
The Oncology Institute (TOI) Clinical Research - 1109
Cerritos, California, 90703
United States
Emad Ibrahim MD Inc. - 1147
Redlands, California, 92373
United States
UC Davis Comprehensive Cancer Center - 1103
Sacramento, California, 95817
United States
Bass Medical Group - 1155
Walnut Creek, California, 94598
United States
Nuvance Health - 1118
Norwalk, Connecticut, 06850
United States
D&H Cancer Research Center LLC - 1153
Margate, Florida, 33063
United States
Ocala Oncology Center PL - 1102
Ocala, Florida, 34474
United States
AdventHealth Cancer Institute - 1105
Orlando, Florida, 32804
United States
Orlando Health - 1130
Orlando, Florida, 32806
United States
Florida Cancer Specialists -South - 1126
Sarasota, Florida, 34232
United States
Florida Cancer Specialists -North - 1125
The Villages, Florida, 32159
United States
Florida Cancer Specialists -East - 1124
West Palm Beach, Florida, 33401
United States
Orchard Healthcare Research, Inc. - 1116
Skokie, Illinois, 60077
United States
Springfield Clinic - The Cancer Center - 1110
Springfield, Illinois, 62702
United States
Fort Wayne Medical Oncology - 1133
Fort Wayne, Indiana, 46805
United States
Deaconess Chancellor Center for Oncology - 1131
Newburgh, Indiana, 47630
United States
Cotton O'Neil Clinical Research Center - 1151
Topeka, Kansas, 66606
United States
University of Kentucky - Markey Cancer Center - 1112
Lexington, Kentucky, 40536
United States
Norton Cancer Institute - 1108
Louisville, Kentucky, 40202
United States
Jefferson City Medical Group - 1145
Jefferson City, Missouri, 65109
United States
MidAmerica Cancer Care - 1163
Kansas City, Missouri, 64132
United States
Astera Cancer Care - 1128
East Brunswick, New Jersey, 08816
United States
Duke University Medical Center - 1158
Durham, North Carolina, 27710
United States
Miami Valley Hospital - 1115
Centerville, Ohio, 45459
United States
University of Cincinnati Cancer Center - 1107
Cincinnati, Ohio, 45219
United States
The Ohio State University James Cancer Center - 1104
Columbus, Ohio, 43210
United States
Tri County Hematology & Oncology Associates, Inc - 1156
Massillon, Ohio, 44646
United States
Oklahoma Cancer Specialists and Research Institute - 1154
Tulsa, Oklahoma, 74146
United States
Oncology Associates of Oregon - 1138
Eugene, Oregon, 97401
United States
St. Luke's University Health Network - 1179
Bethlehem, Pennsylvania, 18015
United States
Donald Guthrie Foundation - 1135
Sayre, Pennsylvania, 18840
United States
Cancer Care Associates of York, Inc. - 1113
York, Pennsylvania, 17403
United States
University of Tennessee Medical Center - 1146
Knoxville, Tennessee, 37920
United States
Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
Nashville, Tennessee, 37203
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
Dallas, Texas, 75246
United States
Texas Oncology - Denison - 1139
Denison, Texas, 75020
United States
Oncology Consultants, P.A. - 1120
Houston, Texas, 77024
United States
Oncology and Hematology of South Texas - 1165
Laredo, Texas, 78041
United States
Texas Oncology - McAllen - 1132
McAllen, Texas, 78503
United States
Texas Oncology -San Antonio - 1122
San Antonio, Texas, 78240
United States
NEXT Oncology - Virginia - 1129
Fairfax, Virginia, 22031
United States
Virginia Cancer Institute - 1149
Henrico, Virginia, 23226
United States
Virginia Oncology Associates - 1136
Norfolk, Virginia, 23502
United States
West Virginia University Cancer Institute - 1172
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: OncoC4, Inc.

  • Mark Socinski, MD, PRINCIPAL_INVESTIGATOR, Advent Health System
  • Tianhong Li, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis
  • Kai He, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

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 Registration Dates

Study Start Date2023-06-28
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-06-28
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer