Russellville

Researchers are evaluating the safety and effectiveness of a new antibody drug called gotistobart (ONC-392/BNT316) compared to the chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has worsened after treatment with PD-1 or PD-L1 inhibitors. This Phase 3 clinical trial aims to see if gotistobart can help patients live longer than with standard chemotherapy. The study will enroll about 630 patients who have squamous cell NSCLC and have shown disease progression on prior immunotherapy. The trial has two stages. In Stage I, two different dosing regimens of gotistobart will be tested against docetaxel to confirm the best dose. Gotistobart is given through a 60-minute intravenous infusion every 21 days at either 3 mg/kg or 6 mg/kg (with two initial loading doses of 10 mg/kg). Docetaxel is given by IV infusion every 21 days at 75 mg/m2. Stage II will compare the chosen gotistobart dose to docetaxel in patients with squamous NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will undergo tumor measurements to confirm disease progression and meet health criteria such as organ function and performance status. Researchers will monitor overall survival over 36 months as the main outcome. Safety and side effects will be closely followed. The study requires patients to have recovered from prior treatment effects and have no active infections or serious heart or lung disease. Through this trial, researchers hope to determine whether gotistobart is a beneficial treatment option for this group of lung cancer patients.