Phase 3 Study Comparing Gotistobart and Docetaxel for Metastatic Non-Small Cell Lung Cancer After Progression on PD-1PD-L1 Inhibitors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of gotistobart ONC-392BNT316, a next-generation anti-CTLA-4 antibody, in patients with metastatic non-small cell lung cancer NSCLC whose disease has progressed after treatment with anti-PD-1 or PD-L1 antibody-based therapies. This Phase 3 clinical trial aims to compare gotistobart with the chemotherapy drug docetaxel to see if it can help prolong life in these patients. Approximately 630 patients will participate, and the study is divided into two stages to confirm dosing and assess outcomes. In Stage I, two dosing regimens of gotistobart will be tested against docetaxel, which is given at 75 mgm2 every 21 days. Gotistobart will be administered by intravenous infusion over 60 minutes every 21 days, either at 3 mgkg or 6 mgkg with two loading doses of 10 mgkg. After selecting the most appropriate dosing regimen, Stage II will compare that gotistobart dose with docetaxel in patients with squamous cell NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will receive regular infusions and be monitored for overall survival over 36 months, along with secondary outcomes like tumor response, progression-free survival, and treatment-related adverse events. Patients must have measurable tumors and meet specific health criteria before joining. The study includes safety monitoring and ongoing assessments to evaluate how well the treatments are tolerated and their effects on cancer progression.

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors