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

Trial Title: 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

NCT ID: NCT06662786

Condition: Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Cetuximab
Amivantamab-vmjw
Calcium
Levoleucovorin

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Amivantamab
Description: Amivantamab will be administered.
Arm group label: Arm A: Amivantamab in Combination With Chemotherapy

Other name: JNJ-61186372

Intervention type: Biological
Intervention name: Cetuximab
Description: Cetuximab will be administered.
Arm group label: Arm B: Cetuximab in Combination With Chemotherapy

Other name: Erbitux

Intervention type: Drug
Intervention name: 5-fluorouracil
Description: 5-fluorouracil will be administered as chemotherapy regimen.
Arm group label: Arm A: Amivantamab in Combination With Chemotherapy
Arm group label: Arm B: Cetuximab in Combination With Chemotherapy

Intervention type: Drug
Intervention name: Leucovorin calcium/Levoleucovorin
Description: Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Arm group label: Arm A: Amivantamab in Combination With Chemotherapy
Arm group label: Arm B: Cetuximab in Combination With Chemotherapy

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Oxaliplatin will be administered as chemotherapy regimen.
Arm group label: Arm A: Amivantamab in Combination With Chemotherapy
Arm group label: Arm B: Cetuximab in Combination With Chemotherapy

Intervention type: Drug
Intervention name: Irinotecan Hydrochloride
Description: Irinotecan hydrochloride will be administered as chemotherapy regimen.
Arm group label: Arm A: Amivantamab in Combination With Chemotherapy
Arm group label: Arm B: Cetuximab in Combination With Chemotherapy

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease - Be diagnosed 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 as determined by local testing - Must agree to the submission of fresh tumor tissue - Have measurable disease according to RECIST v1.1 - 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 unlikely 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) or mesenchymal epithelial transition (MET)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 22, 2024

Completion date: January 20, 2032

Lead sponsor:
Agency: Janssen Research & Development, LLC
Agency class: Industry

Source: Janssen Research & Development, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06662786