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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
NSCLC, Neutropenia, Febrile Neutropenia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Rate of grade 3/4 neutropenia in cycle 1

Outcome Description:

the rate of ANC lower than 1.0 × 109/L

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Caicun Zhou

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Pulmonary Hospital, Shanghai, China

Authority:

China: Food and Drug Administration

Study ID:

HHPG-19K -III-02

NCT ID:

NCT01560195

Start Date:

April 2012

Completion Date:

Related Keywords:

  • NSCLC
  • Neutropenia
  • Febrile Neutropenia
  • neutropenia
  • febrile neutropenia
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Fever
  • Lung Neoplasms
  • Neutropenia

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