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
OncoC4, Inc.
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.
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 gotistobar…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (Major criteria): 1. Adult (≥ 18 years), all genders, capable of signing informed consent. 2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs. 3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: 1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; 2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD…
Interventions
- DrugGotistobart
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
- DrugDocetaxel
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Locations (152)
- XCancer/Dothan Hematology & Oncology - 1114Dothan, Alabama
- Genesis Cancer and Blood Institute - 1123Russellville, Arkansas
- The Oncology Institute (TOI) Clinical Research - 1109Cerritos, California
- Emad Ibrahim MD Inc. - 1147Redlands, California
- UC Davis Comprehensive Cancer Center - 1103Sacramento, California
- Bass Medical Group - 1155Walnut Creek, California