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 (Jun 2026). This Phase 3 trial studies multiple treatments for colorectal neoplasms.
Treatment: Amivantamab · Cetuximab · Bevacizumab · 5-fluorouracil · Leucovorin calcium/Levoleucovorin · Irinotecan — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
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: 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
Excluded: Mismatch-repair deficient (MSI-H / dMMR)
Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
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 →Frequently asked questions
Is NCT06750094 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irinotecan, EGFR-targeted therapy, MET inhibitor disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS G12 wild-type is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS G13 wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS G12 wild-type is a required biomarker for enrollment.
Are patients with MSH2 alterations eligible?
No. MSH2 deficiency (dMMR) is an exclusion criterion.
Are patients with MSH6 alterations eligible?
No. MSH6 deficiency (dMMR) is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages