MedTrace Logo

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

NCT05671510 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Gotistobart

Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

DRUG

Docetaxel

Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • OncoC4, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Socinski, MD · Advent Health System

  • Tianhong Li, MD, PhD · University of California, Davis

  • Kai He, MD, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671510 on ClinicalTrials.gov