OncoMatch/Clinical Trials/NCT06509126
Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
Is NCT06509126 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Panitumumab and Irinotecan for colorectal cancer stage iv.
Treatment: Panitumumab · Irinotecan · 5-fluorouracil · L-folinic acid — The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective in first line as the same regimen given continuously, resulting in a Time to Treatment Failure (TTF) not inferior to that obtained with standard continuous regimen of Panitumumab plus FOLFIRI, in the treatment of metastatic left sided RAS/B-RAF wild-type colorectal cancer patients. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti-EGFR treatment strategy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS/BRAF wild-type
Required: NRAS wild-type
RAS/BRAF wild-type
Required: BRAF wild-type
RAS/BRAF wild-type
Required: MLH1 proficient mismatch repair
pMMR and/or MSS status
Required: MSH2 proficient mismatch repair
pMMR and/or MSS status
Required: MSH6 proficient mismatch repair
pMMR and/or MSS status
Required: PMS2 proficient mismatch repair
pMMR and/or MSS status
Disease stage
Required: Stage IV
Metastatic disease required
Disease judged unresectable by the local multidisciplinary team; Imaging-documented measurable disease, according to RECIST 1.1 criteria.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: previous adjuvant chemotherapy is allowed if terminated > 6 months previously
No prior treatments (chemotherapy, radiation or surgery) for mCRC. Surgery for primary CRC tumor before starting treatment is allowed. Prior chemotherapy or any other medical treatment for mCRC (previous adjuvant chemotherapy is allowed if terminated > 6 months previously).
Cannot have received: radiation therapy
No prior treatments (chemotherapy, radiation or surgery) for mCRC.
Cannot have received: surgery
Exception: Surgery for primary CRC tumor before starting treatment is allowed
No prior treatments (chemotherapy, radiation or surgery) for mCRC. Surgery for primary CRC tumor before starting treatment is allowed.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L and hemoglobin ≥ 9 g/dL
Kidney function
serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (Cockroft-Gault)
Liver function
total bilirubin ≤ 1.5 x ULN or ≤ 2 (in case of biliary stent) and AST/ALT ≤ 5 X ULN
Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L and hemoglobin ≥ 9 g/dL. Adequate liver function: total bilirubin ≤ 1.5 x ULN or ≤ 2 (in case of biliary stent) and AST/ALT ≤ 5 X ULN. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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