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RecruitingPhase 3

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

A Randomized, Open-label Phase 3 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares amivantamab plus chemotherapy with cetuximab plus chemotherapy to see which keeps cancer from getting worse longer. It is for adults with left-sided colon or rectal cancer that cannot be removed by surgery or has spread, and whose tumors have no changes in the KRAS, NRAS, or BRAF genes. These treatments are being tested as the first drug treatment for this stage of cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests must confirm adenocarcinoma, a cancer that starts in gland cells, in the left side of the colon or rectum. It must have spread or be unable to be removed by surgery.
  • Tumor tests must show no changes in the KRAS, NRAS, and BRAF genes.
  • You must agree to give a fresh tumor tissue sample.
  • Your cancer must be measurable using the study's rules.
  • You must not have had drug treatment for cancer that has spread or cannot be removed. Earlier chemotherapy given before or after surgery must have ended more than 12 months before the cancer returned or spread.
  • You must be fully active or able to do light work despite limits on hard physical activity.

Who can't join

  • You have or had lung swelling or scarring not caused by infection, or screening scans cannot rule it out.
  • You have a known allergy, strong reaction, or intolerance to ingredients in amivantamab, cetuximab, or the study chemotherapy drugs.
  • You have or had another cancer that could affect the study's safety or treatment results.
  • Your tumor has both dMMR/MSI-H (problems repairing DNA) and HER2-positive/amplified status (too much HER2 protein or extra copies of its gene).
  • You have received drugs that target EGFR, MET, or VEGF, which help cancer grow or form blood vessels.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (81)

AR

AZ

CA

CO

CT

DC

FL

GA

IA

IL

IN

KS

LA

MD

MI

MO

MS

NC

NE

NJ

NM

NV

NY

OH

OR

PA

TN

TX

VA

WA

WI