Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Lenograstim
Criteria
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