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

Phase 3

• Conditions: NSCLC; Neutropenia; Febrile Neutropenia
• Interventions: Drug: placebo and rhG-CSF 5ug/kg/d

• Registration Number: NCT01560195
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Study Start: 2012-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-04
• Last Update Posted: 2012-11-06
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo and rhG-CSF 5ug/kg/d	Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4

Primary Outcome Measures

Name	Time	Method
Rate of grade 3/4 neutropenia in cycle 1	21 days	the rate of ANC lower than 1.0 × 109/L

Secondary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia in cycle 1	21 days	rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃
Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4	Through 2 to 4 cycles	The rate of ANC lower than 1.0 × 109 /L and rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃
Time to neutrophil recovery in the 4 chemotherapy cycles	Through 4 cycles	After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L
Duration of 3/4 neutropenia in the 4 chemotherapy cycles	Through 4 cycles	duration of ANC lower than 1.0 × 109/L
Objective response rate	Through 4 cycles
Progress free survival	Through 4 cycles
Overall survival	Through 4 cycles
Exploratory biomarkers research	Through 4 cycles	Relationship between SNP and microRNA with myelosuppression and tumor response rate

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China