NCT04793958进行中（未招募）3 期
A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 461
- 试验地点
- 805
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- •Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
排除标准
- •Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- •Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- •Active brain metastasis
研究组 & 干预措施
MRTX849 + Cetuximab
Experimental
干预措施: Cetuximab (Biological)
mFOLFOX6 or FOLFIRI
Active Comparator
干预措施: mFOLFOX6 Regimen (Drug)
mFOLFOX6 or FOLFIRI
Active Comparator
干预措施: FOLFIRI Regimen (Drug)
MRTX849 + Cetuximab
Experimental
干预措施: MRTX849 (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 30 months
Defined as time from date of randomization to date of death due to any cause.
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.
次要结局
- Objective Response Rate (ORR)(30 months)
- Patient Reported Outcomes (PROs)(30 months)
- Duration of Response (DOR)(30 months)
- Adverse Events(30 months)
- Quality of Life Assessment(30 months)
研究者
研究点 (805)
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