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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
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.
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
The incidence rate of Grade ≥3 ANC reduction
The incidence rate of Grade ≥3 ANC reduction during the first chemotherapy cycle for two groups of participants receiving primary and secondary prophylaxis with Efgbemalenograstim alfa in the first treatment cycle.
Time frame: Up to a year and a half after starting chemotherapy
The incidence rate of FN
The incidence rate of febrile neutropenia (FN) for each cycle
Time frame: Up to a year and a half after starting chemotherapy
The incidence rate of Grade ≥3 ANC reduction
The incidence rate of Grade ≥3 ANC reduction during chemotherapy cycles 2-4/6
Time frame: Up to a year and a half after starting chemotherapy
Adverse Events
Including adverse events/serious adverse events and their incidence rates
Time frame: Up to a year and a half after starting chemotherapy
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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