Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Drug | — | UNRESOLVED |
| Pegylated rhG-CSF: 6mg | Drug | — | UNRESOLVED |
| placebo and rhG-CSF 5ug/kg/d | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pegylated rhG-CSF: 100µg/kg
- description
- Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
- interventionNames
- Drug: Pegylated rhG-CSF: 100µg/kg
- type
- EXPERIMENTAL
- label
- Pegylated rhG-CSF: 6mg
- description
- Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg
- interventionNames
- Drug: Pegylated rhG-CSF: 6mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available