Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRate of grade 3/4 neutropenia in cycle 1
the rate of ANC lower than 1.0 × 109/L
Time frame: 21 days
Incidence of febrile neutropenia in cycle 1
rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃
Time frame: 21 days
Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4
The rate of ANC lower than 1.0 × 109 /L and rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃
Time frame: Through 2 to 4 cycles
Time to neutrophil recovery in the 4 chemotherapy cycles
After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L
Time frame: Through 4 cycles
Duration of 3/4 neutropenia in the 4 chemotherapy cycles
duration of ANC lower than 1.0 × 109/L
Time frame: Through 4 cycles
Objective response rate
Time frame: Through 4 cycles
Progress free survival
Time frame: Through 4 cycles
Overall survival
Time frame: Through 4 cycles
Exploratory biomarkers research
Relationship between SNP and microRNA with myelosuppression and tumor response rate
Time frame: Through 4 cycles
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