OncRef

Clinical Trial: NCT05671510

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:OncoC4, Inc.
Information Provided By:OncoC4, Inc.
Last Update Posted:2026-08-13

Study Overview

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Gotistobart
  • Drug: Docetaxel

Other Study ID Numbers

  • PRESERVE-003
  • 2023-505311-20-01
  • 2023

Start Date (Actual)

2023-06-28

Primary Completion Date (Estimated)

2027-08-31

Study Completion Date (Estimated)

2028-08-31

Enrollment (Estimated)

630

Study Type

Interventional

Phase

Phase 3