A Phase III, Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin® in Subjects with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

Samsung Bioepis Co., Ltd.0 个研究点目标入组 678 人开始时间: 2016年2月19日最近更新: 2018年9月17日

适应症

试验速览

暂无简介。

•Subjects must meet all of the following criteria to be eligible for the study:
•1. Aged = 18 years (if local regulations are different in this regard, follow the local regulations).
•2. ECOG performance status of 0-1 at Screening.
•3. Histologically and/or cytologically confirmed metastatic (AJCC 7th edition TNM stage IV) or recurrent non-squamous NSCLC or NSCLC-not otherwise specified (NOS).
•4. At least one measurable lesion according to RECIST v1.1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 339
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 339

•Subjects meeting any of the following criteria are not eligible for the study:
•1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung. For mixed tumour with the component of squamous cell carcinoma, it should be categorised according to predominant histology. Any component of small cell carcinoma of the lung is to be excluded.
•2. Known activating mutations in EGFR gene or transforming rearrangements of ALK gene.
•3. Radiological or clinical evidence of tumour invasion into blood vessels or close to large vessels that may have risk of bleeding at the discretion of Investigator.
•4. History of systemic anti-cancer therapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
•5. Any systemic anti-cancer therapy including neoadjuvant or adjuvant chemotherapy administered for NSCLC and completed less than 12 months prior to Randomisation.
•6. Previously treated with a monoclonal antibody and/or molecule targeting VEGFR-related and/or EGFR-related signalling pathways.
•7. Radiotherapy within 14 days prior to Randomisation (tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy are not considered as measurable lesion unless there has been demonstrated progression in the lesion.).

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