Clinical trial NCT06143735: A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Lung Cancer
Chemotherapy
Efgbemalenograstim alfa
Absolute Neutrophil Count (ANC) Reduction
Febrile Neutropenia
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2023-11-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: The incidence rate of Grade ≥3 ANC reduction
timeFrame: Up to a year and a half after starting chemotherapy
Secondary outcomes:
measure: The incidence rate of FN
timeFrame: Up to a year and a half after starting chemotherapy
measure: The incidence rate of Grade ≥3 ANC reduction
timeFrame: Up to a year and a half after starting chemotherapy
measure: Adverse Events
timeFrame: Up to a year and a half after starting chemotherapy
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: the First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital & Institute
state: Shandong
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
References: