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

NSCLC research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

NSCLC

Neutropenia

Febrile Neutropenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pegylated rhG-CSF: 100µg/kgPatients 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.

Drug:Pegylated rhG-CSF: 6mgPatients 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.

Drug:placebo and rhG-CSF 5ug/kg/dPatients 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pegylated rhG-CSF: 100µg/kgStaged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Pegylated rhG-CSF: 6mgStaged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg

PlaceboStaged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4

Study Status

Unknown status

Start Date: April 2012

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Rate of grade 3/4 neutropenia in cycle 1

Secondary Outcome: Incidence of febrile neutropenia in cycle 1

Study sponsors, principal investigator, and references

Principal Investigator: Caicun Zhou

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01560195

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