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

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Locations (235)