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Looking for participantsPhase3

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06662786

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
Amivantamab (biological), Cetuximab (biological), 5-fluorouracil (drug), Leucovorin calcium/Levoleucovorin (drug)
How long the study runs
Study runs about 87 months (dates as stated)
About the drug or intervention
Amivantamab — biological: Amivantamab will be administered. · Cetuximab — biological: Cetuximab will be administered. · 5-fluorouracil — drug: 5-fluorouracil will be administered as chemotherapy regimen. · Leucovorin calcium/Levoleucovorin — drug: Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. · Oxaliplatin — drug: Oxaliplatin will be administered as chemotherapy regimen. · Irinotecan Hydrochloride — drug: Irinotecan hydrochloride will be administered as chemotherapy regimen.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2024-10-18
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for colorectal neoplasms
  • • Phase3 - 1,000 participants
  • • The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colorectal neoplasms

Where?

  • • Birmingham - Birmingham Heartlands Hospital
  • • Cambridge - Addenbrooke's Hospital
  • • Edinburgh - Western General Hospital
  • • Hull - Castle Hill Hospital
  • • +5 more UK sites

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

About This Trial

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Colorectal Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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

KRASBRAFMSIHER2EGFRMET

Treatment history

Treatments you must have had:

  • ✓ unresectable or metastatic disease
  • ✓ concluded greater than (\>) 12 months

What the study is looking for

  • ✓Have confirmed by testing a sample adenocarcinoma of the left-sided colorectal cancer. Participants must...
  • ✓Must agree to the submission of fresh tumor tissue
  • ✓Have cancer that can be measured on scans according to (standard scan measurements)
  • ✓Have an activity scale (ECOG) performance status (PS) of 0 or 1

Who cannot take part

  • ✗Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or...
  • ✗Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human...
  • ✗Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial...
See the full criteria
Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease * Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available) * Must agree to the submission of fresh tumor tissue * Have measurable disease according to RECIST v1.1 * Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 Exclusion Criteria: * Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor * Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

Where Is This Study? (9 UK sites)

Birmingham Heartlands Hospital

Birmingham B9 5ST, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Castle Hill Hospital

Hull HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

St James University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting

University College Hospital

London NW1 2BU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Mount Vernon Cancer Centre

Northwood HA6 2RN, 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

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09