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OncoMatch/Clinical Trials/NCT05007132

Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

Is NCT05007132 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Panitumumab 20 milligram/ML and Bevacizumab for metastatic colorectal cancer.

Phase 2RecruitingDominik Paul ModestNCT05007132Data as of May 2026

Treatment: Panitumumab 20 milligram/ML · Bevacizumab · Trifluridine/Tipiracil HydrochlorideFIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine / tipiracil and panitumumab (Arm A) compared to trifluridine / tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer. The primary objectives of this study is to compare the effecacy of treatment with trifluridine / tipiracil plus panitumumab versus trifluridine / tipiracil plus bevacizumab.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: KRAS wild-type

Required: NRAS wild-type

Disease stage

Required: Stage IV

Metastatic disease required

Metastatic colorectal cancer (mCRC) with at least one measurable lesion according to RECIST 1.1

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy for metastatic disease

Exception: Prior adjuvant chemotherapy is permitted, if completed > 3 months prior to randomisation. Multimodal treatment of rectal cancer is not considered antimetastatic therapy and does not preclude study participation.

Prior systemic therapy of metastatic disease. Note: Prior adjuvant chemotherapy is permitted, if completed > 3 months prior to randomisation. Multimodal treatment of rectal cancer is not considered antimetastatic therapy and does not preclude study participation

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1.5 x 10^9/L (1500/μL); Hemoglobin ≥ 80 g/L (8 g/dL); Platelet count ≥ 75 x10^9/L (75,000/μL) without transfusion

Kidney function

Calculated GFR ≥ 30 mL/min or serum creatinine ≤ 1.5 x ULN

Liver function

Total serum bilirubin of ≤ 1.5 x ULN; AST/GOT and ALT/GPT ≤ 2.5 × ULN; if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN

Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results: ... (see above for details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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