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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06143735

Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Efgbemalenograstim alfa	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group（primary prevention） Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of each chemotherapy cycle.	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.
Active Comparator: control group（secondary prevention） Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of the next chemotherapy cycle if ≥ Grade 3 ANC reduction occurs in the preceding chemotherapy cycle.	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.

Arm

Intervention/Treatment

Experimental: experimental group（primary prevention）

Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of each chemotherapy cycle.

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.

Active Comparator: control group（secondary prevention）

Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of the next chemotherapy cycle if ≥ Grade 3 ANC reduction occurs in the preceding chemotherapy cycle.

Drug: Efgbemalenograstim alfa

Outcome Measures

Primary Outcome Measures

The incidence rate of Grade ≥3 ANC reduction [Up to a year and a half after starting chemotherapy]
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.

Secondary Outcome Measures

The incidence rate of FN [Up to a year and a half after starting chemotherapy]
The incidence rate of febrile neutropenia (FN) for each cycle
The incidence rate of Grade ≥3 ANC reduction [Up to a year and a half after starting chemotherapy]
The incidence rate of Grade ≥3 ANC reduction during chemotherapy cycles 2-4/6
Adverse Events [Up to a year and a half after starting chemotherapy]
Including adverse events/serious adverse events and their incidence rates

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants voluntarily join this study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up.
At the time of signing the informed consent form, participants must be ≥ 18 years old, with no gender restrictions.
Stage IIIB-IV NSCLC with negative driver mutations, who have not received chemotherapy or radiotherapy previously.
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).
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.
Expected survival of at least 12 weeks.
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

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.
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:

Previously received chemotherapy or radiotherapy, including but not limited to neoadjuvant chemoradiotherapy and/or adjuvant chemoradiotherapy.
Underwent bone marrow transplantation or stem cell transplantation.
Concurrently diagnosed with malignancies other than NSCLC.
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.
Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical, electrocardiogram, or other means.
Has a disease that may cause splenomegaly.
Associated with malignant hematological disorders.
Previously experienced sustained Grade ≥3 neutropenia (ANC <1.0×10^9/L) or febrile neutropenia lasting 3 days or more.
Underwent surgical procedures within the past 4 weeks and/or has an open wound.
Tumor involvement in the bone marrow.
Diagnosed with acute infections, chronic active hepatitis B within the past year (unless known negative for hepatitis B virus antigen before selection), or hepatitis

Pregnant or lactating women.
Known positive serum response to human immunodeficiency virus (HIV) or diagnosed with AIDS.
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.
Sickle cell anemia.
Known allergy to granulocyte colony-stimulating factors or drug excipients.
Rubber allergy.
Use of other investigational drugs within the past month before enrollment.
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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Henan Provincial People's Hospital	Zhengzhou	Henan	China
2	Hubei Cancer Hospital	Wuhan	Hubei	China
3	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia	China
4	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China
5	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China
6	Shandong Cancer Hospital & Institute	Jinan	Shandong	China
7	Sichuan Cancer Hospital	Chengdu	Sichuan	China
8	Sichuan Provincial People's Hospital	Chengdu	Sichuan	China
9	Ningbo No.2 Hospital	Ningbo	Zhejiang	China
10	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China