NCT06252649
Recruiting
Phase 3
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)
ConditionsMetastatic Colorectal Cancer
Overview
- Phase
- Phase 3
- Intervention
- FOLFIRI Regimen
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Amgen
- Enrollment
- 450
- Locations
- 572
- Primary Endpoint
- PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Intervention: FOLFIRI Regimen
Arm A: Sotorasib + Panitumumab + FOLFIRI
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Intervention: Sotorasib
Arm A: Sotorasib + Panitumumab + FOLFIRI
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Intervention: FOLFIRI Regimen
Arm A: Sotorasib + Panitumumab + FOLFIRI
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Intervention: Panitumumab
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Intervention: Bevacizumab-awwb
Outcomes
Primary Outcomes
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to Approximately 3 Years
Secondary Outcomes
- 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))
Study Sites (572)
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