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

NCT06143735 | Not Yet Recruiting Phase 2

• 1 other identifier: GUARD-03
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 10

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)

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer; Chemotherapy; Efgbemalenograstim alfa; Absolute Neutrophil Count (ANC) Reduction; Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence rate of FN

  Up to a year and a half after starting chemotherapy

• The incidence rate of Grade ≥3 ANC reduction

  Up to a year and a half after starting chemotherapy

• Adverse Events

  Up to a year and a half after starting chemotherapy

Study Arms (2)

experimental group（primary prevention）

EXPERIMENTAL

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

Drug: Efgbemalenograstim alfa

control group（secondary prevention）

ACTIVE COMPARATOR

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

Interventions

Efgbemalenograstim alfa DRUG

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.

control group（secondary prevention）; experimental group（primary prevention）

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 C.
• 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.

Sponsors & Collaborators

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

Study Sites (10)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Dingzhi Huang

CONTACT

+86-22-23340123-1031; dingzhih72@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: December 31, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.

Locations

CN (10)