drugset / Trial / NCT02383966

Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

NCT02383966

Phase 3 Completed 243 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.

Timeline

Start
2015-07-31
Primary completion
2018-01-19
Completion
2021-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Carboplatin Small molecule 75 mg/m2 Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background fluorouracil Small molecule 750 mg/m2 Intravenous