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

Official record

Identifier

NCT06252649

Recruiting locations

countries

United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileColombiaCzechiaDenmarkEstoniaFranceGermanyGreeceHong KongHungaryItalyJapanMexicoNetherlandsPolandPortugalPuerto RicoRomaniaSlovakiaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United Kingdom

Interventions studied

FOLFIRI RegimenSotorasibPanitumumabBevacizumab-awwb

Lead sponsor

Amgen

Target enrolment

450 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Feb 12, 2024

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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