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Taking people in MexicoPhase 3

Tests sotorasib with panitumumab and FOLFIRI in colorectal cancer

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

Key facts

Who runs it
Amgen
Where
Benito Juárez, Mexico City, and Monterrey, MexicoSee the 4 sitesAlso in 34 other countries, 287 sites
Trial code
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
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
17 Jul 2024
Expected to end
25 Apr 2032
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FOLFIRI Regimen
  • Sotorasib
  • Panitumumab
  • Bevacizumab-awwb
Record updated
3 September 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Mexico

Also in 34 other countries, 287 sites

  • Centro Especializado en Investigacion y Tratamiento Oncologicos SCBenito Juárez, MexicoTaking people
  • Health Pharma Professional Research SA de CVMexico City, MexicoTaking people
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránMexico City, MexicoTaking people
  • Hospital Universitario Dr. Jose Eleuterio GonzálezMonterrey, MexicoNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm A: Sotorasib + Panitumumab + FOLFIRITreatment being tested

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

    Treatment: FOLFIRI Regimen, Sotorasib, and Panitumumab

  • Arm B: FOLFIRI with or Without Bevacizumab-awwbExisting treatment, for comparison

    Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.

    Treatment: FOLFIRI Regimen and Bevacizumab-awwb

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests sotorasib with panitumumab and FOLFIRI in colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06252649, who can take part
Record updated
3 September 2026