Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Tianhong Li, MD, PhD (ucdavis)

Description

Summary

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.

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

Details

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.

Keywords

Non Small Cell Lung Cancer, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Docetaxel, Gotistobart, Gotistobart 3 mg/kg Q3W, Docetaxel 75 mg/m2, Q3W

Eligibility

Locations

  • UC Davis Comprehensive Cancer Center - 1103 accepting new patients
    Sacramento California 95817 United States
  • The Oncology Institute (TOI) Clinical Research - 1109 accepting new patients
    Cerritos California 90703 United States
  • Bass Medical Group - 1155 accepting new patients
    Walnut Creek California 94598 United States

Lead Scientist at University of California Health

  • Tianhong Li, MD, PhD (ucdavis)
    Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 65 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OncoC4, Inc.
ID
NCT05671510
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated