drugset / Trial / NCT00983047

Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer

NCT00983047

Phase 2 Terminated 30 enrolled Biotech Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung cancer to assess the efficacy and safety.

Timeline

Start
2009-08
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg Intravenous
Background Docetaxel Small molecule 75 mg/m2