Recruiting NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Phase III Interventional Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb.
Who it may be relevant to: Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +30
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

Drug FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Drug Sotorasib
Immediate-release solid dosage form administered orally.
Drug Panitumumab
Administered via IV infusion Q2W.
Drug Bevacizumab-awwb
Administered via IV infusion Q2W.

Primary outcome measures

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [Time frame: Up to Approximately 3 Years]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to Approximately 5 Years]
Objective Response Rate (ORR) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Objective Response (OR) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Duration of Response (DOR) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Disease Control Rate (DCR) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Time to Response (TTR) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Depth of Response per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
PFS Based on Investigator's Assessment per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
ORR Based on Investigator's Assessment per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
DOR Based on Investigator's Assessment per RECIST v1.1 [Time frame: Up to Approximately 5 Years]
DCR Based on Investigator's Assessment per RECIST v1.1 [Time frame: Up to Approximately 5 Years]

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 ≤ 1.
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment