EUCTR2018-002147-28-HR进行中（未招募）1 期
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non Squamous Non Small Cell Lung Cancer
CELLTRION, Inc.0 个研究点目标入组 678 人开始时间: 2019年5月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 678
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient (male or female) must be = 18 years of age.
- •2. Patient must have confirmed predominantly non-squamous non-small
- •cell lung cancer (nsNSCLC) by hematoxylin and eosin staining or
- •immunohistochemistry.
- •3. Patient must be diagnosed as recurrent disease or stage IV according
- •to the American Joint Committee on Cancer (AJCC) Lung Cancer Staging
- •8th edition. Stage IV is defined as below:
- •a. Separate tumor nodule(s) in a contralateral lobe, or
- •b. Tumor with pleural or pericardial nodules, or
- •c. Malignant pleural or pericardial effusion related to tumor, or
- •d. Single or multiple extrathoracic metastases in a single organ or in
- •multiple organs
- •4. Patient must have at least 1 measurable lesion by Response
- •Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Target lesions
- •situated in a previously irradiated area are considered measurable if
- •recurrence has been demonstrated in such lesions.
- •a. Tumor lesions: = 10 mm in long axis by computerized tomography
- •(CT) scan, or
- •b. Malignant lymph nodes: = 15 mm in short axis by CT scan
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •6. Life expectancy > 6 months based on clinical judgement
- •7. Negative result in both epidermal growth factor receptor (EGFR)
- •mutation and anaplastic lymphoma kinase (ALK) rearrangement which is
- •confirmed by biopsy or cytology specimens.
- •8. Patient must have adequate organ function as follows. These tests
- •must be performed within 14 days prior to Day 1 of Cycle 1.
- •Bone marrow reserve:
- •a. Hemoglobin = 9.0 g/dL, and
- •b. Absolute neutrophil count = 1,500/mm3, and
- •c. Platelet count = 100,000/mm3
- •a. Alkaline phosphatase, aspartate aminotransferase and alanine
- •aminotransferase = 3.0 × upper limit of normal (ULN) (= 5.0 × ULN with
- •liver metastasis), and
- •b. Total bilirubin = 1.5 × ULN
- •a. Serum creatinine = 1.5 × ULN, and
- •b. Creatinine clearance (CrCl) rate = 45 mL/min, and
- •c. Urine dipstick for proteinuria < 1+ (i.e., either 0 or trace); if urine
- •dipstick is = 1+ then < 1.0 g of protein in 24 hours urine collection must
- •be confirmed to allow participation in the study
- •9. Patient and their partner of childbearing potential must agree to use
- •acceptable birth control methods throughout the study and for 6 months
- •after the last dose of assigned treatment
- •A man or woman is of childbearing potential if, in the opinion of the
- •investigator, he or she is biologically capable of having children and is
- •sexually active. Male and female patients and their partners who have
- •been surgically sterilized for less than 24 weeks prior to the date of
- •informed consent must agree to use any medically acceptable methods
排除标准
- •1. Patient who has predominantly squamous cell histology non-small cell
- •lung cancer (NSCLC). If small cell elements are present, the patient is
- •ineligible.
- •2. Patient who has clinically significant third-space fluid; for example,
- •ascites or pleural effusions that cannot be controlled by drainage or
- •other procedures prior to Day 1 of Cycle 1.
- •3. Patient who has untreated central nervous system (CNS) metastases
- •or CNS metastasis with bleeding risk at investigator's discretion and/or
- •leptomeningeal disease. However, treated and clinically stable
- •(asymptomatic; off steroids) brain metastases are allowed.
- •4. Patient who has invasion of major blood vessels. Patient with a tumor
- •cavitation in the opinion of the investigator is likely to bleed will be
- •excluded as well.
- •5. Patient who has received previous anti-cancer systemic therapy:
- •Cytotoxic chemotherapy for metastatic nsNSCLC, Cytotoxic
- •chemotherapy for non-metastatic nsNSCLC within 12 months prior to
- •Day 1 of Cycle 1, Anti-neoplastic biological therapy, immunotherapy or
- •targeted therapy, Bevacizumab (or a bevacizumab proposed biosimilar
- •6. Patient who has received previous surgical procedure including:
- •Surgery for metastatic nsNSCLC, Surgery for non-metastatic nsNSCLC
- •within 6 months prior to Day 1 of Cycle 1, Open biopsy or open
- •pleurodesis within 28 days prior to Day 1 of Cycle 1, Core biopsy or other
- •minor surgical procedure (e.g. placement of vascular access device,
- •closed pleurodesis, thoracentesis, and mediastinoscopy) within 14 days
- •prior to Day 1 of Cycle 1.
- •7. Patient who has received previous anti-cancer radiotherapy including
- •one or more of the following(s):
- •a. Radiotherapy for metastatic nsNSCLC, but radiotherapy as part of the
- •palliative therapy and/or treatment for CNS metastases completed at
- •least 14 days prior to Day 1 of Cycle 1 is allowed,
- •b. Radiotherapy for non-metastatic nsNSCLC within 6 months prior to
- •Day 1 of Cycle 1,
- •c. Any toxicity related with radiotherapy prior to Day 1 of Cycle 1.
- •8. Patient who has a medical history of disease including one or more of
- •the following(s):
- •a. Clinically significant allergic reactions such as asthma, urticaria,
- •angio-oedema, and eczematous dermatitis, hypersensitivity to any
- •component of carboplatin, paclitaxel, bevacizumab and Chinese Hamster
- •Ovary (CHO) cell products or other recombinant human or humanized
- •antibodies.
- •b. Cardiac, gastrointestinal, renal, hepatic, hematological (including
- •pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including
- •known diabetes mellitus), autoimmune disease, or pulmonary diseases
- •classed as significant in the opinion of the investigator.
- •c. A known infection with hepatitis B (active or carrier of hepatitis B
研究者
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