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
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
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.
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.
Inclusion Criteria (Major criteria):
Adult (≥ 18 years), all genders, capable of signing informed consent.
Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.
Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.
At least one measurable tumor lesion according to RECIST 1.1.
ECOG score of 0 or 1.
Adequate organ functions. Serum LDH level ≤ 2xULN.
Life expectancy ≥ 3 months.
Exclusion Criteria (Major criteria):
Nashville, Tennessee 37203, United States
Dallas, Texas 75246, United States
Guangzhou, Guangdong, China
Zhengzhou, Hebei 71000, China
Chongqing, Sichuan, China
Hangzhou, Zhejiang, China
Shanghai, 200120, China
Immenstädt, 87509, Germany
Muenchen-Gauting, 82131, Germany
Perugia, 06132, Italy
Birmingham, England B15 2TG, United Kingdom