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OncoMatch/Clinical Trials/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

Is NCT06662786 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for colorectal neoplasms.

Phase 3RecruitingJanssen Research & Development, LLCNCT06662786Data as of May 2026

Treatment: Amivantamab · Cetuximab · 5-fluorouracil · Leucovorin calcium/Levoleucovorin · Oxaliplatin · Irinotecan HydrochlorideThe 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: KRAS wild-type

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)

Required: NRAS wild-type

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)

Required: BRAF wild-type

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)

Excluded: MSH2 deficiency

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: MSH6 deficiency

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: MLH1 deficiency

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: PMS2 deficiency

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: MSI high

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: HER2 (ERBB2) overexpression

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Excluded: HER2 (ERBB2) amplification

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: EGFR-targeted therapy

Has prior exposure to any agents that target epidermal growth factor receptor (EGFR)

Cannot have received: MET inhibitor

Has prior exposure to any agents that target...mesenchymal epithelial transition (MET)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • St. Bernard's Medical Center · Jonesboro, Arkansas
  • Highlands Oncology Group · Springdale, Arkansas
  • CBCC Global Research · Bakersfield, California
  • Los Angeles Cancer Network · Glendale, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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