A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

Eikon Therapeutics77 个研究点分布在 1 个国家目标入组 70 人开始时间: 2024年2月6日最近更新: 2026年5月28日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Eikon Therapeutics
入组人数: 70
试验地点: 77
主要终点: Percentage of participants with safety event during treatment

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相关资讯

研究概览

简要总结

This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.

详细描述

This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

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

•be ≥ 18 years of age on the day of signing of informed consent.
•confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
•have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
•have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
•have not received prior systemic treatment for advanced/metastatic NSCLC.
•have an ECOG Performance Status of 0 to
•have adequate organ function.

排除标准

•does not have predominantly squamous cell or non-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 in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK
•prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (< 3 weeks prior to the first dose).
•has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
•has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
•has an active infection requiring therapy.