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.
There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
the nimotuzumab treatment: 200mg/w weekly, for 16 weeks. A treatment:nimotuzumab for 3 levels (100mg/w, 200mg/w, 400mg/w, weekly, for 16 weeks).
Concurrent Chemotherapy,50mg/m2 (d1,d8),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy: Cisplatin: 50mg/m2 (d1,d8)4 weeks/cycle, for 2 cycles.
Concurrent Chemotherapy, Cisplatin: Etoposide: 50mg/m2 (d1-5),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy:Etoposide: 50mg/m2 (d1-5),4 weeks/cycle, for 2 cycles.
the tolerance trial of treatment A and B of treatment;95%PTV,60-66Gy/30-33/fraction,6-7weeks.
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Progression-free survival
Time frame: 12months
Overall survival Time
Time frame: 3 years
Quality of life
Time frame: 12 months
Objective response rate
Time frame: 12months
Disease controlled rate
Time frame: 3 years
Adverse event rate
Time frame: 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks
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