NCT05671510

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (estimated)
• Sponsor: OncoC4, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 630 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 on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-28
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2023-01-04
• Last updated: 2026-04-14

Locations

152 sites across 12 countries: United States, Australia, Belgium, Canada, China, Germany, Italy, Netherlands, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study