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A Study of Amivantamab or Cetuximab for Left-Sided Colorectal Cancer

This study is for adults with advanced left-sided colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. You may be eligible if your cancer has specific genetic markers (KRAS, NRAS, and BRAF wild-type). The study compares two different treatments: amivantamab combined with chemotherapy (mFOLFOX6 or FOLFIRI), or cetuximab combined with the same chemotherapy. Researchers want to see which treatment helps people live longer without their cancer getting worse (progression-free survival). This will be measured for up to 4 years and 2 months.

Study design
This interventional study plans to enroll 1000 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to 4 years and 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06662786

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~1,000 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AmivantamabCetuximab5-fluorouracilLeucovorin calcium/LevoleucovorinOxaliplatinIrinotecan Hydrochloride

At a glance

Recruiting sites
233 of 239 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Measured over Up to 4 years and 2 months

Conditions

Colorectal Neoplasms

Explore related trials

Colorectal Carcinoma

Where it's being run

239 sites across 54 states
China22
Ohio11
Brazil11
Germany10
France9
Japan9
Poland9
Turkey (Türkiye)9

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Up to 4 years and 2 months

    PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.