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Looking for participantsPhase3

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

Sponsor: Amgen

NCT ID: NCT06252649

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
FOLFIRI Regimen (drug), Sotorasib (drug), Panitumumab (drug), Bevacizumab-awwb (drug)
How long the study runs
Study runs about 93 months (dates as stated)
About the drug or intervention
FOLFIRI Regimen — drug: Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W. · Sotorasib — drug: Immediate-release solid dosage form administered orally. · Panitumumab — drug: Administered via IV infusion Q2W. · Bevacizumab-awwb — drug: Administered via IV infusion Q2W.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
450
Started
2024-07-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic colorectal cancer
  • • Phase3 - 450 participants
  • • The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic colorectal cancer

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • London - Royal Free Hospital
  • • London - Guys Hospital
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metastatic Colorectal Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRAS

What the study is looking for

  • ✓Pathologically documented that has spread colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  • ✓Central laboratory detection of KRAS p.G12C mutation.
  • ✓Measurable that has spread disease per (standard scan measurements) criteria.
  • ✓activity scale (ECOG) Performance Status of ≤ 1.
  • ✓healthy organ.

Who cannot take part

  • ✗Active, untreated brain metastases.
  • ✗Leptomeningeal disease
  • ✗Previous treatment with a KRAS p.G12C inhibitor
  • ✗History of interstitial pneumonitis or lung fibrosis or evidence of interstitial pneumonitis or lung...
See the full criteria
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

Where Is This Study? (10 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Guys Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

Maidstone Hospital

Maidstone ME16 9QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

Recruiting

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

Recruiting

Royal Marsden Hospital - Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09