临床试验/jRCT2041240020

jRCT2041240020招募中不适用

A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC) (Jimmy-Lung)

Hexal AG0 个研究点目标入组 60 人开始时间: 2024年10月29日最近更新: 2024年11月27日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Hexal AG
入组人数: 60
主要终点: Best overall response (BOR)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Double Blind

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•At least 18 years of age
•Untreated metastatic NSCLC
•Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements
•Measurable disease according to RECIST 1.1
•Adequate organ function
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•Other protocol-defined inclusion criteria apply.

排除标准

•Squamous cell or mixed histology in NSCLC
•Known history of hypersensitivity (grade >=3) to pembrolizumab, chemotherapy or their excipients
•Active autoimmune disease that has required chronic systemic treatment in the past 2 years.
•Received live vaccine <=30 days before the first study treatment
•Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer.
•Other protocol-defined exclusion criteria apply.

结局指标

主要结局

Best overall response (BOR)

时间窗: up to 9 months

Complete response (CR) or Partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

次要结局

overall survival (OS)(52 weeks)
duration of response (DOR)(52 weeks)
progression free survival (PFS)(52 weeks)
treatment-emergent adverse events (TEAEs) and serious TEAEs(52 weeks)
Trough level (Ctrough)
development of binding and neutralizing anti-drug antibodies (ADAs)(52 weeks)

研究者

发起方

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