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A Study of Amivantamab and FOLFIRI for Colorectal Cancer

This study is for people with colorectal cancer that has spread or cannot be removed, and who have already received chemotherapy. It focuses on a specific type of cancer where certain genes (KRAS/NRAS and BRAF) are "wild-type," meaning they don't have common mutations. The study compares two treatment approaches: amivantamab combined with FOLFIRI chemotherapy (5-fluorouracil, leucovorin calcium/levoleucovorin, and irinotecan hydrochloride) versus either cetuximab or bevacizumab, also with FOLFIRI. Researchers want to see which treatment helps people live longer without their cancer getting worse (progression-free survival) and which helps people live longer overall (overall survival). About 700 people are expected to join this study. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 700 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 2 years and 1 month, and for overall survival for up to 4 years and 4 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.

NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~700 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AmivantamabCetuximabBevacizumab5-fluorouracilLeucovorin calcium/LevoleucovorinIrinotecan

At a glance

Recruiting sites
238 of 251 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 2 years 1 month
+1 more outcome measured

Conditions

Colorectal Neoplasms

Explore related trials

Colorectal Carcinoma

Where it's being run

251 sites across 52 states
China20
Spain14
Turkey (Türkiye)11
Brazil10
Japan10
Texas9
Mexico9
Poland9

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 colon or rectum. Participants must have recurrent, unresectable or metastatic disease
Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

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: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments
Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

What this trial measures

  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Up to 2 years 1 month

    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.

  • Overall Survival (OS)Up to 4 years 4 months

    OS is defined as the time from the date of randomization to the date of participant's death due to any cause.