NCT06143735

A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-12-31
• Primary completion: 2024-12-31
• Completion: 2026-06-30
• First posted: 2023-11-22
• Last updated: 2023-11-22

Locations

10 sites across 1 country: China