NCT06252649招募中3 期
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 450
- 试验地点
- 562
- 主要终点
- PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
研究概览
简要总结
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
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
- •Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
- •Central laboratory detection of KRAS p.G12C mutation.
- •Measurable metastatic disease per RECIST v1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
- •Adequate organ function.
排除标准
- •Active, untreated brain metastases.
- •Leptomeningeal disease
- •Previous treatment with a KRAS p.G12C inhibitor
- •History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
研究组 & 干预措施
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Active Comparator
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
干预措施: FOLFIRI Regimen (Drug)
Arm A: Sotorasib + Panitumumab + FOLFIRI
Experimental
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
干预措施: Sotorasib (Drug)
Arm A: Sotorasib + Panitumumab + FOLFIRI
Experimental
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
干预措施: FOLFIRI Regimen (Drug)
Arm A: Sotorasib + Panitumumab + FOLFIRI
Experimental
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
干预措施: Panitumumab (Drug)
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Active Comparator
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
干预措施: Bevacizumab-awwb (Drug)
结局指标
主要结局
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
时间窗: Up to Approximately 3 Years
次要结局
- Disease Control Rate (DCR) per RECIST v1.1(Up to Approximately 5 Years)
- Time to Response (TTR) per RECIST v1.1(Up to Approximately 5 Years)
- Depth of Response per RECIST v1.1(Up to Approximately 5 Years)
- Time to Early Tumor Shrinkage (ETS) per RECIST v1.1(Up to Approximately 5 Years)
- PFS Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- DOR Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Depth of Response Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Time to ETS Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Number of Participants Experiencing Adverse Events (AEs)(Up to Approximately 5 Years)
- Pre-dose (Ctrough) Concentrations of Sotorasib(Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days))
- Maximum Plasma Concentration (Cmax) of Sotorasib(Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days))
- Overall Survival (OS)(Up to Approximately 5 Years)
- Objective Response Rate (ORR) per RECIST v1.1(Up to Approximately 5 Years)
- Objective Response (OR) per RECIST v1.1(Up to Approximately 5 Years)
- Duration of Response (DOR) per RECIST v1.1(Up to Approximately 5 Years)
- Disease Control Rate (DCR) per RECIST v1.1(Up to Approximately 5 Years)
- Time to Response (TTR) per RECIST v1.1(Up to Approximately 5 Years)
- Depth of Response per RECIST v1.1(Up to Approximately 5 Years)
- Time to Early Tumor Shrinkage (ETS) per RECIST v1.1(Up to Approximately 5 Years)
- PFS Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- ORR Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- DOR Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- DCR Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- TTR Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Depth of Response Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Time to ETS Based on Investigator's Assessment per RECIST v1.1(Up to Approximately 5 Years)
- Number of Participants Experiencing Adverse Events (AEs)(Up to Approximately 5 Years)
- Pre-dose (Ctrough) Concentrations of Sotorasib(Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days))
- Maximum Plasma Concentration (Cmax) of Sotorasib(Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days))
研究者
研究点 (562)
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