Trial Title:
A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
NCT ID:
NCT06143735
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neutropenia
Febrile Neutropenia
Conditions: Keywords:
Lung Cancer
Chemotherapy
Efgbemalenograstim alfa
Absolute Neutrophil Count (ANC) Reduction
Febrile Neutropenia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Efgbemalenograstim alfa
Description:
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.
Arm group label:
control group（secondary prevention）
Arm group label:
experimental group（primary prevention）
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)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants voluntarily join this study, sign an informed consent form, exhibit
good compliance, and cooperate with follow-up.
2. At the time of signing the informed consent form, participants must be ≥ 18 years
old, with no gender restrictions.
3. Stage IIIB-IV NSCLC with negative driver mutations, who have not received
chemotherapy or radiotherapy previously.
4. Planned to undergo platinum-based (carboplatin/cisplatin) combined with taxane-based
(paclitaxel/albumin-bound paclitaxel/liposomal paclitaxel/paclitaxel polymer
micelles) chemotherapy regimen (may be combined with immunotherapy or
anti-angiogenic therapy).
5. Have other risk factors related to febrile neutropenia (FN), including but not
limited to age ≥65 years, poor nutritional/physical condition (i.e., ECOG score ≥2),
etc.
6. Expected survival of at least 12 weeks.
7. Normal function of major organs, meeting the following criteria:
- Complete blood count criteria (no blood transfusion in the past 14 days, no use
of G-CSF or other hematopoietic growth factors for correction):
- Hemoglobin (Hb) ≥ 90g/L
- Absolute neutrophil count (ANC) ≥ 2.0×10^9/L
- Platelets (PLT) ≥ 80×10^9/L
- Biochemical criteria:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN
- Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance rate (CrCl) ≥ 50 ml/min
8. Women of childbearing potential must have implemented reliable contraceptive
measures or undergone a serum pregnancy test within 7 days before enrollment, with a
negative result.
9. Male and female participants of childbearing age must agree to use reliable
contraceptive methods from before entering the trial, throughout the study, and for
8 weeks after discontinuation.
Exclusion Criteria:
1. Previously received chemotherapy or radiotherapy, including but not limited to
neoadjuvant chemoradiotherapy and/or adjuvant chemoradiotherapy.
2. Underwent bone marrow transplantation or stem cell transplantation.
3. Concurrently diagnosed with malignancies other than NSCLC.
4. Active central nervous system metastasis and/or carcinomatous meningitis, except for
asymptomatic brain metastasis subjects (i.e., no progressive central nervous system
symptoms caused by brain metastases, no need for corticosteroids, and lesion size
≤1.5 cm) are allowed.
5. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial
infarction by clinical, electrocardiogram, or other means.
6. Has a disease that may cause splenomegaly.
7. Associated with malignant hematological disorders.
8. Previously experienced sustained Grade ≥3 neutropenia (ANC <1.0×10^9/L) or febrile
neutropenia lasting 3 days or more.
9. Underwent surgical procedures within the past 4 weeks and/or has an open wound.
10. Tumor involvement in the bone marrow.
11. Diagnosed with acute infections, chronic active hepatitis B within the past year
(unless known negative for hepatitis B virus antigen before selection), or hepatitis
C.
12. Pregnant or lactating women.
13. Known positive serum response to human immunodeficiency virus (HIV) or diagnosed
with AIDS.
14. Active tuberculosis or recent history of contact with a tuberculosis patient unless
tuberculin test is negative; or receiving treatment for tuberculosis; or suspected
cases on chest X-ray.
15. Sickle cell anemia.
16. Known allergy to granulocyte colony-stimulating factors or drug excipients.
17. Rubber allergy.
18. Use of other investigational drugs within the past month before enrollment.
19. The investigator believes the participant has a disease or symptoms that make them
unsuitable for participation in this study, and the investigational drug may harm
the participant's health or affect the judgment of adverse events.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Tianhui Gao
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Country:
China
Contact:
Last name:
Caixia Liu
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Contact:
Last name:
Wei Zheng
Facility:
Name:
the First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Facility:
Name:
Shandong Cancer Hospital & Institute
Address:
City:
Jinan
Country:
China
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Huangming Hong
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Haitao Lan
Facility:
Name:
Ningbo No.2 Hospital
Address:
City:
Ningbo
Country:
China
Contact:
Last name:
Chuangzhou Rao
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Dingzhi Huang
Start date:
December 31, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06143735
