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 (CodeBreaK 301)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI Regimen; Drug: Bevacizumab-awwb; Drug: Panitumumab; Drug: Sotorasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06252649

20210081

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
• Central confirmation 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Arm A: Sotorasib + Panitumumab + FOLFIRI

Experimental group

Description:

Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV).

Treatment:

Drug: Sotorasib

Drug: Panitumumab

Drug: FOLFIRI Regimen

Arm B: FOLFIRI with or Without Bevacizumab-awwb

Active Comparator group

Description:

Participants received FOLFIRI Q2W with or without bevacizumab-awwb.

Treatment:

Drug: Bevacizumab-awwb

Drug: FOLFIRI Regimen