Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

January 1, 2026

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2031

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

FOLFIRI+cetuximab

Cetuximab 500 mg/m², 90 min IV infusion on d1; Irinotecan: 180 mg/m², 90-120 min IV infusion on d1; Folinic acid: 400mg/m², 1-2h IV Infusion on d1; 5-FU: 2400 mg/m², 46 h IV infusion on d1. Cycles are repeated on day 15.

DIAGNOSTIC_TEST

Guardant360 ctDNA assay

Determination of circulating tumor DNA (ctDNA) in the peripheral blood, part 1: retrospective threshold determination to predict radiological disease progression in Arm 2; part 2: prospective validation of the in part 1 identified ctDNA threshold to guide the scheduled treatment breaks and treatment in Arm 2

Trial Locations (1)

10117

Charite University, Berlin, Berlin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany

UNKNOWN

collaborator

Guardant Health, Inc.

INDUSTRY

lead

Charite University, Berlin, Germany

OTHER