Guthrie Organization | Donald Guthrie Foundation - Sayre
Status and phase
Conditions
Treatments
About
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.
Full 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. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (Major criteria):
Adult (≥ 18 years), all genders, capable of signing informed consent.
Histologically- or cytologically- confirmed diagnosis of metastatic 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):
Primary purpose
Allocation
Interventional model
Masking
600 participants in 3 patient groups
Loading...
Central trial contact
Pan Zheng, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal