NCT07833202尚未招募3 期
A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
Shanghai Jeyou Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
- •Has KRAS G12C mutation confirmed by central laboratory.
- •Measurable disease according to RECIST 1.
- •An Eastern Cooperative Group (ECOG) performance status of 0 or
- •Adequate organ function.
- •Life expectancy ≥3 months in the opinion of the Investigator
- •Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment
排除标准
- •Has another known driver mutation with approved first-line targeted therapy.
- •Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
- •Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
- •History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- •Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
- •Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
- •Any condition that, in the opinion of the Investigator, would interfere with participation or study results
研究组 & 干预措施
Study Arm
Experimental
Sosimerasib in combination with IN10018
干预措施: Sosimerasib in combination with IN10018 (Drug)
Control Arm
Active Comparator
anti-PD-1 monoclonal antibody in combination with chemotherapy
干预措施: Tislelizumab + Carboplatin + Pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 30 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
次要结局
- Objective Response Rate (ORR)(30 months)
- Overall Survival (OS)(up to 60 months)
- Disease Control Rate (DCR)(30 months)
- Duration of Response (DoR)(30 months)
- PFS by investigator assessment(up to 30 months)
- Number of participants with adverse event(30 months)
- Patient-reported outcome (PRO) questionnaire including EORTC QLQ-C30(up to 30 months)
- Patient-reported outcome (PRO) questionnaire including EORTC QLQ-LC13.(up to 30 months)
研究者
研究点 (1)
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