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Taking people in ChilePhase 3

Tests sotorasib with panitumumab and FOLFIRI in colorectal cancer

Compares sotorasib combination treatment with FOLFIRI in adults with KRAS-mutated colorectal cancer.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Providencia, Santiago, Temuco, Valdivia, and Vitacura, ChileSee the 8 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that has spread and has a KRAS p.G12C gene change, who have not had treatment for it before.

Age
18 years or older
Sex
All sexes can join
Disease stage
Colorectal adenocarcinoma that has spread (metastatic), confirmed by a pathology report, with disease that can be measured on scans (RECIST v1.1).
Earlier treatment
The trial is for people who have not been treated before (treatment-naïve). People who had a KRAS p.G12C inhibitor cannot join.
Biomarker or test result
KRAS p.G12C mutation, found by a locally validated test and confirmed by a central laboratory.

Main reasons for not taking part

  • Active brain metastases that have not been treated
  • Leptomeningeal disease
  • Earlier treatment with a KRAS p.G12C inhibitor
  • History or signs of interstitial pneumonitis or pulmonary fibrosis on the baseline CT scan

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
  • Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
  • Do you have now, or have you ever had, a lung disease with scarring or swelling of the lungs, such as pulmonary fibrosis (scarring of the lungs) or pneumonitis?

Source: NCT06252649, who can take part

Where in Chile

  • Enroll SpAProvidencia, ChileNo longer taking part
  • Centro de Oncologia de Precision (Medicina de Precision Celerity)Santiago, ChileTaking people
  • Fundacion Arturo Lopez PerezSantiago, ChileTaking people
  • Biocinetic servicios medicos limitadaSantiago, ChileNo longer taking part
  • James Lind Centro De Investigacion Del CancerTemuco, ChileTaking people
  • Centro de investigacion y desarrollo oncolgico SpaTemuco, ChileNo longer taking part
  • Clinical Research Chile Spa.Valdivia, ChileNo longer taking part
  • Clinica Redsalud Vitacura, Instituto del CancerVitacura, ChileNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Amgen
Trial code
NCT06252649
Record updated
3 September 2026
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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: Previous treatment with a KRAS p.G12C inhibitor; Leptomeningeal disease; History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan; Active, untreated brain metastases.

ClinicalTrials.gov NCT06252649