Anti-EGFR Agents in Patients With Right-sided Advanced Colorectal Cancer With Wild-type RAS and AREG/EREG High Status
NCT07094893 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2026-01-14
Summary
The aim of this trial is to assess the feasibility of EREG/AREG assessment as a clinical diagnostic standard, used to guide clinical decision making in right-PTL, RAS-wt aCRC. Further to this, the aim is to determine whether EREG/AREG status identifies right-PTL participants who will benefit from the addition of anti-EGFR therapy to first-line chemotherapy.
Conditions
Interventions
- DRUG
-
Cetuximab (EGFR inhibitor)
Administration according to the labels of each IMP.
- DRUG
-
Administration according to the labels of each IMP.
- DRUG
-
Irinotecan (CPT-11)
Administration according to the labels of each IMP.
- DRUG
-
Administration according to the labels of each IMP.
- DRUG
-
Leucovorin and 5-FU
Administration according to the labels of each IMP.
- DRUG
-
Administration according to the labels of each IMP.
Sponsors & Collaborators
-
Merck Serono International SA
collaborator INDUSTRY -
Gruppo Oncologico del Nord-Ovest
lead OTHER
Principal Investigators
-
Chiara Cremolini, MD, PhD · Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2028-03-31
- Completion
- 2030-03-31
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