NCT00983047

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

Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nimotuzumab and Docetaxel will be administered to the patient until disease progression or unacceptable toxicity had occurred.Docetaxel was administered every 3 weeks 75mg/m2; Nimotuzumab treatment at 200mg per week,at least 12 weeks.The patients'hematology and biochemistry examination will be monitored weekly, a physical exam and assessment of the tumor will be performed and every 6 weeks. The patients will be followed up every 3 months to evaluate the survival.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab and Docetaxel	The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\\PR\\SD. No more than 4 cycles chemotherapy was given. Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2009-09-23
• Last updated: 2015-08-27

Locations

1 site across 1 country: China