Neutropenia, Chemotherapy-Induced FebrilePhase 3NCT06711523
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
A Phase 3 study testing PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) and PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) in people with Neutropenia, Chemotherapy-Induced Febrile and Breast Neoplasm Female, run by Kexing Biopharm Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
- What is being tested?
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) and PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.);
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- 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;
- Patients with severe mouth ulcers;
- Participated in 3 or more clinical trials of a drug within the last year, or participated in any clinical trial of a drug within the last 3 months, as a subject and actually used the test drug;
- Hypersensitivity to the adjuvant or neoadjuvant chemotherapeutic agents used (e.g., docetaxel, epirubicin, carboplatin, cyclophosphamide) and to PEG-G-CSF and G-CSF analogs;
- Lithium-treated patients were required during the clinical trial;
- Alcohol-dependent individuals or those with a history of substance abuse;
- Lactating and pregnant females and those planning a pregnancy within 6 months of the last injection of the test drug in this study;
- Combined primary diseases of the cerebrovascular, hepatic, renal, endocrine, and hematologic systems of a severity judged by the investigator to be inappropriate for participation in this clinical trial;
- Other patients who, in the judgment of the investigator, are not suitable subjects for this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy
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.
- Being tested
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.), PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of 4th degree neutropenia during chemotherapy cycle 1
Measured: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (8)
Lowest neutrophil count during chemotherapy cycle 1;
Measured: 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;
Measured: At the end of Cycle 1 (each cycle is 21 days)
Duration of 4th degree neutropenia during cycles 2, 3, and 4 of chemotherapy;
Measured: 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;
Measured: 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;
Measured: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Incidence of neutropenic fever (FN) during cycles 1, 2, 3, and 4 of chemotherapy;
Measured: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Incidence of infection during cycles 1, 2, 3, and 4 of chemotherapy;
Measured: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Proportion of participants using antibiotics during cycles 1, 2, 3, and 4 of chemotherapy.
Measured: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start9 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia, Chemotherapy-Induced FebrileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexing Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711523
- Sponsor's protocol ID
- KXZY-KB201702-301
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy
- ClinicalTrials.gov ID
- NCT06711523
- Acronym / sponsor ID
- KXZY-KB201702-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kexing Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) | Experimental | Drug: PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)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. |
| PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) | Active comparator | Drug: PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)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. | Drug | PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) |
| PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)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. | Drug | PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) |
Primary outcome
Duration of 4th degree neutropenia during chemotherapy cycle 1
Time frame: At the end of Cycle 1 (each cycle is 21 days)
8 secondary outcomes
Lowest neutrophil count during chemotherapy cycle 1;
Time frame: 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;
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Duration of 4th degree neutropenia during cycles 2, 3, and 4 of chemotherapy;
Time frame: 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;
Time frame: 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;
Time frame: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Incidence of neutropenic fever (FN) during cycles 1, 2, 3, and 4 of chemotherapy;
Time frame: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Incidence of infection during cycles 1, 2, 3, and 4 of chemotherapy;
Time frame: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Proportion of participants using antibiotics during cycles 1, 2, 3, and 4 of chemotherapy.
Time frame: At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) and PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) in people with Neutropenia, Chemotherapy-Induced Febrile and Breast Neoplasm Female, run by Kexing Biopharm Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of 4th degree neutropenia during chemotherapy cycle 1 (time frame: At the end of Cycle 1 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.