OncoMatch/Clinical Trials/NCT06226857
Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
Is NCT06226857 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Cetuximab for colorectal neoplasms.
Treatment: Cetuximab — Patients meeting the inclusion criteria will be randomized 1:1 into Cohort A (n ≈ 177) or Cohort BC (n ≈ 177). Cohort A is the control: patients receive combination chemotherapy with FOLFOX plus anti-EGFR therapy (panitumumab or cetuximab) based on RAS/BRAF wild-type data, according to clinical guidelines. The BC cohort begins FOLFOX chemotherapy and simultaneously undergoes extensive molecular genetic profiling. Further, the BC cohort, depending on the profile, is divided into cohort B - patients without changes in alternative oncogenes, and cohort C - with changes in alternative oncogenes. The expected cohort ratio is 3:1 (\~120 and \~40 patients). Cohort B begins to receive anti-EGFR therapy in addition to chemotherapy, and the potentially resistant cohort C continues to receive chemotherapy alone or begins to receive bevacizumab if there are no contraindications.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Required: NRAS wild-type
Excluded: BRAF v600e
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy
Exception: neo-/adjuvant therapy completed at least 6 months before the detection of metastases is allowed
Previous systemic therapy for metastatic disease
Lab requirements
Blood counts
absolute number of neutrophils ≥ 1.5×10^9/l; platelets ≥ 100×10^9/l; hemoglobin ≥ 90 g/l
Kidney function
creatinine clearance above 50 ml/min
Liver function
total bilirubin <1.5 x uln; alt or ast >5 x uln with liver metastases or >2.5 x uln without liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06226857 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF v600e is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 99 years or younger.
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