Recruiting 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

Phase III Interventional Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin.
Who it may be relevant to: Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Brazil, Canada, China +17
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Biological Amivantamab
Amivantamab will be administered.
Biological Cetuximab
Cetuximab will be administered.
Drug 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Drug Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Drug Oxaliplatin
Oxaliplatin will be administered as chemotherapy regimen.
Drug Irinotecan Hydrochloride
Irinotecan hydrochloride will be administered as chemotherapy regimen.

Primary outcome measures

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to 4 years and 2 months]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to 7 Years 3 Months]
Objective Response Rate (ORR) as Assessed by BICR [Time frame: Up to 7 Years 3 Months]
Objective Response Rate (ORR) as Assessed by Investigator [Time frame: Up to 7 Years 3 Months]
Progression Free Survival (PFS) as Assessed by Investigator [Time frame: Up to 7 Years 3 Months]
Duration of Response (DOR) as Assessed by BICR [Time frame: Up to 7 Years 3 Months]
Duration of Response (DOR) as Assessed Investigator [Time frame: Up to 7 Years 3 Months]
Time to Response (TTR) as Assessed by BICR [Time frame: Up to 7 Years 3 Months]
Time to Response as Assessed by Investigator [Time frame: Up to 7 Years 3 Months]
Progression-free Survival After Subsequent Therapy (PFS2) [Time frame: Up to 7 Years 3 Months]
Disease Control Rate (DCR) as Assessed by BICR [Time frame: Up to 7 Years 3 Months]
Disease Control Rate (DCR) as Assessed by Investigator [Time frame: Up to 7 Years 3 Months]
Time to Treatment Failure [Time frame: Up to 7 Years 3 Months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment