drugset / Trial / NCT02549261

Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer

NCT02549261

Unknown 150 enrolled Biotech Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.

Timeline

Start
2011-03
Primary completion
2012-04
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 100 mg
Subject Nimotuzumab Monoclonal antibody 200 mg
Subject Nimotuzumab Monoclonal antibody 400 mg
Background Cisplatin Other / unclassified 50 mg/m2
Background Etoposide Small molecule 50 mg/m2