CTRI/2025/05/087296招募中3 期
MK1084-004-A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS more than or equal to 50%.
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年7月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Progression-Free Survival (PFS) ( MK-1084 plus pembrolizumab with placebo plus pembrolizumab )
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
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Demographics Is an individual of any sex gender, from at least 18 years of age at the time of providing the informed consent.
- •Has a histologically or cytologically confirmed diagnosis of NSCLC.
- •Has newly diagnosed Stage IV (M1a, M1b, or M1c) by AJCC Staging Manual, Version 8 Has provided tumor tissue that demonstrates PD-L1 expression in more than or equal to 50 percent of tumor cells(TPS more than or equal to 50 percent) as assessed by IHC 22C3 at a central laboratory.
- •Has life expectancy of at least 3 months.
- •Has ECOG performance status of 0 or 1 assessed within 7 days before randomization.
- •Has adequate organ function Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
排除标准
- •An individual must be excluded from the study if the individual meets any of the following criteria Diagnosis of small cell lung cancer.
- •For mixed tumors, if small cell elements are present Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- •Has an active infection requiring systemic therapy.
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease Received prior systemic anticancer therapy for their metastatic NSCLC Has received previous treatment with an agent targeting KRAS mutations Has received radiotherapy within 2 weeks of start of study intervention Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has experienced an early recurrence (less than 6 months after completing adjuvant or neoadjuvant chemotherapy) and therefore is eligible to receive second line (2L) treatment Has known active CNS metastases and or carcinomatous meningitis Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy History or current evidence of any condition, therapy, laboratory abnormality.
结局指标
主要结局
Progression-Free Survival (PFS) ( MK-1084 plus pembrolizumab with placebo plus pembrolizumab )
时间窗: From baseline to 07 years 0r PFS(whichever achieved first).
Overall Survival (OS)
时间窗: From baseline to 07 years 0r PFS(whichever achieved first).
次要结局
- Objective response: CR or PR(Baseline and Up to 72 Months)
- Duration of Response (DOR)(Upto 72 Months)
- AE and Disscontinuation from the study due to(an AE)
- Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item 29 and 30(Baseline and Upto 72 Months)
- Change from baseline in physical functioning score, on the EORTC QLQ-C30, item 1-5
- Role functioning score, on the EORTC QLQ-C30, item 6-7(Dyspnea score, on the EORTC QLQ-C30, item 8)
研究者
Dr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
研究点 (4)
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