Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy

NCT06711523 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: KXZY-KB201702-301
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.) as a positive control.

Conditions

Neutropenia, Chemotherapy-Induced Febrile; Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• Duration of 4th degree neutropenia during chemotherapy cycle 1

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (8)

• Lowest neutrophil count during chemotherapy cycle 1;

  At the end of Cycle 1 (each cycle is 21 days)

• Time required for neutrophil count to recover from nadir to above 2.0 × 109/L during chemotherapy cycle 1;

  At the end of Cycle 1 (each cycle is 21 days)

• Duration of 4th degree neutropenia during cycles 2, 3, and 4 of chemotherapy;

  At the end of cycles 2, 3, and 4 (each cycle is 21 days)

• Incidence of 3rd or 4th degree neutropenia during cycles 1, 2, 3, and 4 of chemotherapy;

  At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)

• Duration of febrile neutropenia (FN) in cycles 1, 2, 3, and 4 of chemotherapy;

  At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)

Study Arms (2)

PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)

EXPERIMENTAL

A single subcutaneous injection of 6 mg PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) was administered 24h+2h after the end of chemotherapy administration on day 1 of each chemotherapy cycle; Inject at least 1 cycle of chemotherapy with PEG-G-CSF injection, and up to 4 cycles of chemotherapy.

Drug: PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)

PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)

ACTIVE COMPARATOR

Single subcutaneous injection of 6 mg PEG-G-CSF injection ( Neulasta®, Amgen Europe B.V.) 24h+2h after the end of chemotherapy administration on day 1 of each chemotherapy cycle in the abdomen (5 cm beyond the umbilicus); Inject at least 1 cycle of chemotherapy with PEG-G-CSF injection, and up to 4 cycles of chemotherapy.

Drug: PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)

Interventions

PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) DRUG

This trial was conducted using the IWRS system where subjects were randomly assigned to the test group (PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)) and control group (Neulasta®，Amgen Europe B.V.) in a 1:1 ratio.

PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)

PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) DRUG

This trial was conducted using the IWRS system where subjects were randomly assigned to the test group (PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)) and control group (Neulasta®，Amgen Europe B.V.) in a 1:1 ratio.

PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, ≤75 years
• Female breast cancer patients with a pathohistologically confirmed diagnosis requiring first-time adjuvant or neoadjuvant chemotherapy and for whom the following regimens are appropriate: ① EC regimen (epirubicin 90 mg/m2 iv day 1, cyclophosphamide 600 mg/m2 iv day 1) ② TC regimen (cyclophosphamide 600 mg/m2 iv day 1, docetaxel 75 mg/m2 iv day 1) ③ TCb regimen ( docetaxel 75 mg/m2 iv day 1, carboplatin AUC=5 iv day 1); Note: TCb regimens such as the combination of anti-HER2 targeting drugs H (trastuzumab) and P (pertuzumab) can also be included.
• Physical condition ECOG score ≤ 1;
• Weight ≥ 45kg;
• Peripheral blood cell counts eligible for chemotherapy: white blood cell (WBC) count ≥ 3.5 x 109/L, neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin (HB) ≥ 90 g/L, platelet (PLT) count ≥ 100 x 109/L, normal coagulation or abnormalities of no clinical significance, and no tendency to bleed;
• Survival is expected to be 6 months or more;
• The subject is willing to use an appropriate method of contraception for the duration of the trial;
• Subjects agreed to follow the trial treatment protocol and visit schedule, enrolled voluntarily, and signed a written informed consent form.

You may not qualify if:

• The subjects who have received radiation therapy within 4 weeks prior to randomization;
• Those who have received hematopoietic stem cell transplantation or bone marrow transplantation
• Patients who have been treated with G-CSF analogs or PEG-G-CSF analogs within 4 weeks prior to randomization;
• Subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes;
• People at high risk for ARDS;
• Patients with unexplained splenomegaly on physical examination and/or CT scan or ultrasound, as well as any condition that may cause splenomegaly (e.g., thalassemia, glandular fever, malaria, etc.);
• Patients who currently have or have had sickle cell anemia;
• Those with a combined history of malignant tumors (except for the following: cured non-melanoma skin cancer, cervical cancer in situ, limited prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years);
• Those diagnosed with advanced breast cancer combined with distant metastases;
• Patients with known cerebrovascular malformations (e.g., cerebral hemangiomas), epilepsy;
• Patients with severe mental or neurological disorders;
• Patients with severe cardiovascular disease: history of myocardial infarction within 1 year prior to first administration of study drug; sick sinus syndrome, atrioventricular block II or greater, ventricular fibrillation, torsional ventricular tachycardia, sustained ventricular tachycardia; electrocardiogram indicative of abnormal clinically significant QRS wave lowering; congenital prolonged history of the QT interval; left ventricular ejection fraction \<50%; NYHA cardiac function class III or IV; poorly controlled hypertension. Poorly controlled hypertension: blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic despite antihypertensive medications; congestive heart failure; stable coronary artery disease; unstable angina pectoris;
• Liver function indexes: ALT, AST, TBIL ≥1.5 times the upper limit of normal before enrollment; Kidney function indexes: Scr ≥1.5 times the upper limit of normal;
• Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B Virus (HBV) DNA test is greater than the normal range; Positive for Hepatitis C Virus (HCV); Positive for Human Immunodeficiency Virus (HIV);
• Those with a current active infection (and a temperature ≥38°C) or who have received systemic anti-infective therapy within 72 hours prior to chemotherapy;

Sponsors & Collaborators

• Kexing Biopharm Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2024-11

Locations

CN (1)