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OncoMatch/Clinical Trials/NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Is NCT06750094 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for colorectal neoplasms.

Phase 3RecruitingJanssen Research & Development, LLCNCT06750094Data as of May 2026

Treatment: Amivantamab · Cetuximab · Bevacizumab · 5-fluorouracil · Leucovorin calcium/Levoleucovorin · IrinotecanThe purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: KRAS G12 wild-type

KRAS G12 wild type status by local and/or central next-generation sequencing (NGS) testing

Required: KRAS G13 wild-type

KRAS G13 wild type status by local and/or central next-generation sequencing (NGS) testing

Required: NRAS G12 wild-type

NRAS G12 wild type status by local and/or central next-generation sequencing (NGS) testing

Required: NRAS G13 wild-type

NRAS G13 wild type status by local and/or central next-generation sequencing (NGS) testing

Required: BRAF V600 wild-type

BRAF V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing

Excluded: MSH2 deficiency (dMMR)

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Excluded: MSH6 deficiency (dMMR)

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Excluded: MLH1 deficiency (dMMR)

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Excluded: PMS2 deficiency (dMMR)

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Excluded: MSI high (MSI-H)

Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Excluded: HER2 (ERBB2) positive/amplified

Participant with known 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

Max 1 prior line
Min 1 prior line

Must have received: fluoropyrimidine-based chemotherapy — metastatic

Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy.

Must have received: oxaliplatin-based chemotherapy — metastatic

Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy.

Cannot have received: irinotecan

Has prior exposure to irinotecan

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

  • Ironwood Cancer and Research Center · Chandler, Arizona
  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • Arizona Oncology Associates PC NAHOA · Prescott, Arizona
  • St. Bernard's Medical Center · Jonesboro, Arkansas
  • Highlands Oncology Group · Springdale, Arkansas

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

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