ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
- Registration Number
- NCT05671510
- Lead Sponsor
- OncoC4, Inc.
- Brief 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.
- 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 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 on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W Gotistobart Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. Arm 2: Gotistobart 3 mg/kg Q3W Gotistobart Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. Arm 3: Docetaxel 75 mg/m2, Q3W Docetaxel Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 36 months OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) 36 months Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Treatment emergent adverse events, treatment related adverse events and immune related adverse events. 36 months Incidence of TEAEs, TRAEs, irAEs will be calcuated. The AEs leading to treatment discontinuation will be recorded.
Progression-free survival (PFS) 36 months Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1
Trial Locations
- Locations (160)
XCancer/Dothan Hematology & Oncology - 1114
🇺🇸Dothan, Alabama, United States
Genesis Cancer and Blood Institute - 1123
🇺🇸Russellville, Arkansas, United States
The Oncology Institute (TOI) Clinical Research - 1109
🇺🇸Cerritos, California, United States
Emad Ibrahim MD Inc. - 1147
🇺🇸Redlands, California, United States
UC Davis Comprehensive Cancer Center - 1103
🇺🇸Sacramento, California, United States
Bass Medical Group - 1155
🇺🇸Walnut Creek, California, United States
Nuvance Health - 1118
🇺🇸Norwalk, Connecticut, United States
D&H Cancer Research Center LLC - 1153
🇺🇸Margate, Florida, United States
Ocala Oncology Center PL - 1102
🇺🇸Ocala, Florida, United States
AdventHealth Cancer Institute - 1105
🇺🇸Orlando, Florida, United States
Scroll for more (150 remaining)XCancer/Dothan Hematology & Oncology - 1114🇺🇸Dothan, Alabama, United StatesJawaunna Blackmon, MDPrincipal Investigator