Onco Wiki / Regimen

Sotorasib + Cetuximab (CodeBreaK 300, KRAS G12C+ mCRC)

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Source YAML: complete record

ComponentsDRUG-SOTORASIB DRUG-CETUXIMAB
IDREG-SOTORASIB-CETUXIMAB-CRC
TypeRegimen
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025

Notes

CodeBreaK 300 Phase III (2024): KRAS G12C+ chemo-refractory mCRC, sotorasib 960 mg + cetuximab vs investigator-choice chemo (TAS-102 / regorafenib). mPFS 5.6 vs 2.2 mo (HR 0.49); ORR 26%. Mechanistic rationale: KRAS G12C inhibition triggers EGFR feedback reactivation; concurrent EGFR blockade prevents bypass. FDA approval 2024 for combination. Note: in NSCLC sotorasib monotherapy is approved 2L+; in CRC the combination with cetuximab is the standard.

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Indication