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

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

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 Overview

• Status: Unknown
• Conditions: NSCLC; Neutropenia; Febrile Neutropenia
• Intervention / Treatment: Drug: Pegylated rhG-CSF: 100µg/kg; Drug: Pegylated rhG-CSF: 6mg; Drug: placebo and rhG-CSF 5ug/kg/d

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Caicun Zhou, M. D.; Email: caicunzhou@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegylated rhG-CSF: 100µg/kg; Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg	Drug: Pegylated rhG-CSF: 100µg/kg; 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.
Experimental: Pegylated rhG-CSF: 6mg; Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg	Drug: Pegylated rhG-CSF: 6mg; 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.
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 4, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: chemotherapy; neutropenia; febrile neutropenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: HHPG-19K -III-02