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

A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

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.

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.