Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

NCT ID: NCT04466137

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2021-09-01

Brief Summary

This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.

Conditions

Non-Myeloid Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

YPEG-rhG-CSF 2mg

YPEG-rhG-CSF 2mg

Group Type: EXPERIMENTAL

YPEG-rhG-CSF

Intervention Type: DRUG

YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

YPEG-rhG-CSF 33μg/kg

YPEG-rhG-CSF 33μg/kg

Group Type: EXPERIMENTAL

YPEG-rhG-CSF

Intervention Type: DRUG

YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

Positive Control Group

rhG-CSF/PEG-rhG-CSF

Group Type: ACTIVE_COMPARATOR

rhG-CSF/PEG-rhG-CSF

Intervention Type: DRUG

rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10\^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.

Interventions

YPEG-rhG-CSF

YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

Intervention Type: DRUG

YPEG-rhG-CSF

YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

Intervention Type: DRUG

rhG-CSF/PEG-rhG-CSF

rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10\^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histopathology and/or cytology diagnosed as breast cancer (BC) or non-small cell lung cancer (NSCLC), and patients with breast cancer is suitable to receive TAC(Docetaxel,Doxorubicin combined with Cyclophosphamide) chemotherapy, while patients with NSCLC is suitable to receive DC(Docetaxel combined with Carboplatin) chemotherapy.
• Age ≥18 yrs.
• Weight ≥45 kg.
• Karnofsky Score ≥ 70.
• Life Expectancy ≥ 3 months.
• Peripheral blood test: WBC≥3.5×10^9 cells/L, PLT≥100×10^9 cells/L. ANC≥1.5×10^9 cells/L.
• Understand and voluntarily sign the informed consent form.

Exclusion Criteria

• Receiving chemotherapy within two months prior to screening.
• Previously or plan to receive radiotherapy (>25% total bone marrow volume).
• Evidence of tumor metastasis in bone marrow.
• Lack of awareness.
• Uncontrolled infection or using of antibiotics within 72hrs prior to screening.
• Previously received or plan to undergoing bone marrow or organ transplants.
• Patients with bleeding tendency, e.g. prolonged prothrombin time of more than 3 seconds.
• Dysfunction in heart,lung, liver, kidney, or other major organs or systems; ALT>2.5 ULN (upper limit of normal), TBil >2.5 ULN (ALT>2.5 ULN, total bilirubin >2.5 ULN for patients with liver metastasis), HBsAg positive, anti-HCV positive, evidence of liver decompensation, or Cr >1.5 ULN.
• Pregnant or lactating females.
• Malignancy other than BC or NSCLC.
• Hypersensitivity to rhG-CSF or any component of the investigational Products.
• Subject enrolled in any other studies within 3 months prior to screening.
• Drug abuser or alcoholics.
• Any other conditions which in the opinion of the investigator precluded enrollment into the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

References

Shi Y, Wang X, Pei Z, Shi H, Zhang Y, Yi T, Mei J, Guo Y, Dong Y, Ma T, Zhang Q, Jia X, Zhu Z, Xu S, Liu Y, Niu H, Jiang W, Jiang X, Zhou S, Sun L. Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study. BMC Cancer. 2025 Mar 17;25(1):490. doi: 10.1186/s12885-025-13736-6.

Reference Type: DERIVED

PMID: 40098083 (View on PubMed)

Other Identifiers

TB1801CSF

Identifier Type: -

Identifier Source: org_study_id