A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 Plus Chemotherapy Versus Keytruda® Plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants With Stage IV Non-squamous Non-small Cell Lung Cancer.

Bio-Thera Solutions1 个研究点分布在 1 个国家目标入组 162 人开始时间: 2024年7月19日最近更新: 2025年12月2日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方
入组人数: 162
试验地点: 1
主要终点: clinical equivalence

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

详细描述

This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants are eligible to be included in the study only if all the following criteria are met:
•Male or female, age ≥18 years on the day of signing informed consent.
•Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
•Life expectancy ≥3 months, per the investigator's evaluation.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
•Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.

排除标准

•Participant must be excluded from participating in the study if the participant:
•Is pregnant or a nursing female.
•Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
•Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.
•Before the first dose of study intervention:
•Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy
•Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG
•Has participated in any other BAT3306 study and has been treated with BAT
•Had major surgery <3 weeks prior to first dose
•Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study intervention.
•Completed palliative radiotherapy within 14 days of the first dose of study intervention.
•Is expected to require any other form of antineoplastic therapy while participating in the study. and so on