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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital
Beijing, China
Median Survival Time
Time frame: 12 months
Disease control rate
Time frame: 12 months
Time to progression
Time frame: 12 months
Safety of the Nimotuzumab and docetaxel (NCI CTC3.0)
Time frame: 12 months
Quality of life before and after the treatment (QLQ-C30)
Time frame: 12 months
Analysis EGFR expression, EGFR mutation and amplification, K-ras mutation in the tumor tissues
Time frame: 12 months
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