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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 (Jun 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 Jun 2026Location: Germany

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

Treatments studied

Targeted therapy

Bevacizumab

Other

Panitumumab 20 milligram/MLTrifluridine/Tipiracil Hydrochloride

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.

Frequently asked questions

Is NCT05007132 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.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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