OncoMatch/Clinical Trials/NCT07389265
Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer
Is NCT07389265 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Erbitux (Cetuximab) and Bevacizumab for metastatic colorectal cancer (mcrc).
Treatment: Erbitux (Cetuximab) · Bevacizumab · FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) · FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) — The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. The study will compare the effectiveness of chemotherapy given together with cetuximab versus chemotherapy given together with bevacizumab. Researchers aim to determine whether cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety in this patient population. Eligible participants are adults with metastatic colorectal cancer who have previously responded to first-line treatment with chemotherapy combined with an anti-EGFR antibody. Before starting therapy, patients will undergo molecular testing using liquid biopsy to confirm tumor characteristics. They will then receive chemotherapy with either cetuximab or bevacizumab every two weeks, and their disease will be monitored regularly with CT or MRI scans, laboratory tests, and clinical evaluations. During the study, patients will also provide biological samples for translational research. This trial will enroll about 360 patients across sites in Italy and Spain and is designed to provide new evidence on whether cetuximab continuation beyond first-line treatment can offer a meaningful clinical benefit compared with standard therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis.
Required: NRAS wild-type
RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis.
Required: BRAF wild-type
RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis.
Required: KRAS wild-type (exon 2, 3, and 4)
RAS (NRAS and KRAS exon 2,3 and 4)...wild-type in liquid biopsy at the time of screening
Required: NRAS wild-type (exon 2, 3, and 4)
RAS (NRAS and KRAS exon 2,3 and 4)...wild-type in liquid biopsy at the time of screening
Required: BRAF wild-type (V600E)
BRAFV600E...wild-type in liquid biopsy at the time of screening
Required: PIK3CA wild-type
PIK3CA...wild-type in liquid biopsy at the time of screening
Required: EGFR ECD wild-type
EGFR ECD wild-type in liquid biopsy at the time of screening
Required: HER2 (ERBB2) not amplified
HER2 not amplified in liquid biopsy at the time of screening
Excluded: MSH2 deficient mismatch repair (dMMR)
Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient.
Excluded: MSH6 deficient mismatch repair (dMMR)
Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient.
Excluded: MLH1 deficient mismatch repair (dMMR)
Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient.
Excluded: PMS2 deficient mismatch repair (dMMR)
Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-EGFR drug — first line
Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease. Progression to first line therapy.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN
Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters: Bone marrow: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL; Platelets ≥ 100 x 10^9/L. Liver function: Serum total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN. Renal function: Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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