A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy

Conditions
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NSCLC, Neutropenia, Febrile Neutropenia

Intervention / Treatment
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* Drug: Pegylated rhG-CSF: 100µg/kg
* Drug: Pegylated rhG-CSF: 6mg
* Drug: placebo and rhG-CSF 5ug/kg/d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Investigator diagnosis of staged III or IV NSCLC Age 18 to 70 years ECOG performance status ≤ 1 Chemotherapy naïve Body weight ≥ 45kg Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN Exclusion Criteria: History of systematic chemotherapy or radical radiation therapy Prior bone marrow or stem cell transplantation Received systemic antibiotics treatment within 72 h of chemotherapy Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated rhG-CSF: 100µg/kg<br>Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg | Drug: Pegylated rhG-CSF: 100µg/kg<br>* 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.<br>|
| Experimental: Pegylated rhG-CSF: 6mg<br>Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg | Drug: Pegylated rhG-CSF: 6mg<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4 | Drug: placebo and rhG-CSF 5ug/kg/d<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of grade 3/4 neutropenia in cycle 1 | the rate of ANC lower than 1.0 × 109/L | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia in cycle 1 | rate of ANC<1.0×109/L and auxiliary temperature>38.5℃ | 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℃ | 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 | Through 4 cycles | 
| Duration of 3/4 neutropenia in the 4 chemotherapy cycles | duration of ANC lower than 1.0 × 109/L | Through 4 cycles | 
| Objective response rate |  | Through 4 cycles | 
| Progress free survival |  | Through 4 cycles | 
| Overall survival |  | Through 4 cycles | 
| Exploratory biomarkers research | Relationship between SNP and microRNA with myelosuppression and tumor response rate | Through 4 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia, febrile neutropenia, chemotherapy