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A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in NSCLC patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN)
Official title: A Randomized, Multicenter, Exploratory Clinical Study for The Primary And Secondary Prevention of Febrile Neutropenia (FN) With Efbemalenograstim Alfa in Patients With Non-small Cell Lung Cancer (NSCLC) at Moderate Risk Undergoing Chemotherapy Regimens With Associated Risk Factors
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2023-12-31
Completion Date
2026-06-30
Last Updated
2023-11-22
Healthy Volunteers
No
Conditions
Interventions
Efgbemalenograstim alfa
Efbemalenograstim alfa Injection is a recombinant fusion protein composed of the double molecules of human granulocyte colony-stimulating factor (G-CSF) and the Fc fragment of human immunoglobulin (hIgG2). It is used for adult patients with non-myeloid malignancies undergoing myelosuppressive anticancer therapy that is associated with a high risk of febrile neutropenia, to reduce the incidence of infections manifested by febrile neutropenia.
Locations (10)
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China