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

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 Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Efgbemalenograstim alfa

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dingzhi Huang; Phone Number: +86-22-23340123-1031; Email: dingzhih72@163.com

Study Locations

• China
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital
    • Contact: Dingzhi Huang
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
      • Contact: Tianhui Gao
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • The Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Caixia Liu
  • Liaoning
    • Shenyang, Liaoning, China
      • Shengjing Hospital of China Medical University
      • Contact: Wei Zheng
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China
      • Shandong Cancer hospital & institute
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Cancer Hospital
      • Contact: Huangming Hong
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
      • Contact: Haitao Lan
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Ningbo No.2 Hospital
      • Contact: Chuangzhou Rao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to a year and a half after starting chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of FN	The incidence rate of febrile neutropenia (FN) for each cycle	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	Up to a year and a half after starting chemotherapy
Adverse Events	Including adverse events/serious adverse events and their incidence rates	Up to a year and a half after starting chemotherapy

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Lung Cancer; Chemotherapy; Febrile Neutropenia; Efgbemalenograstim alfa; Absolute Neutrophil Count (ANC) Reduction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Agranulocytosis; Leukopenia; Leukocyte Disorders; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: GUARD-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individal participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No