drugset / Trial / NCT07509099

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC

NCT07509099

Phase 3 Not yet recruiting 316 enrolled Ji Dongmei
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R/M HNSCC.

Timeline

Start
2026-04-01
Primary completion
2030-09-30
Completion
2030-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Finotonlimab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous