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

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

Trial Details

NCT ID
NCT06662786
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Amivantamab
  • Cetuximab
  • 5-fluorouracil
  • Leucovorin calcium/Levoleucovorin
  • Oxaliplatin
  • Irinotecan Hydrochloride
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Bakersfield, California, United States|35.37329,-119.01871
  • Glendale, California, United States|34.14251,-118.25508

Key Eligibility Criteria

  • Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastati…
  • Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncog…
  • Must agree to the submission of fresh tumor tissue
  • Have measurable disease according to RECIST v1.1

For full eligibility, visit ClinicalTrials.gov.

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