5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

December 30, 2030

Conditions
Colorectal CarcinomaKRAS G12C MutationUnresectable Colorectal Cancer
Interventions
DRUG

Administration of experimental treatment association (sotorasib, panitumumab 5FU)

Panitumumab is administered at a dose of 6 mg/kg via intravenous infusion over one hour during the first cycle, and over 30 minutes from the second cycle onward. The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion, followed by a 5-FU bolus (400 mg/m² over 10 minutes), and a continuous 5-FU infusion (2400 mg/m² over 46 hours). Sotorasib is given orally at a dose of 960 mg once daily on a continuous basis.

Trial Locations (80)

Unknown

ICO site Paul Papin, Angers

Centre Hospitalier Annecy Genevois, Annecy

Hôpital Privé, Antony

Centre Hospitalier, Aurillac

Centre Hospitalier, Bayeux

Ch Cote Basque, Bayonne

Ch Simone Veille, Beauvais

Chu Jean Minjoz, Besançon

Polyclinique Courlancy, Bezannes

Centre Hospitalier Béthune Beuvry, Béthune

Bordeaux Nord Aquitaine, Bordeaux

TIVOLI, Bordeaux

Chu Morvan, Brest

CHU Côte de Nacre, Caen

Centre Hospitalier, Cholet

Hôpitaux civils, Colmar

Polyclinique Saint-Côme, Compiègne

Chu Francois Mitterand, Dijon

Gf Leclerc, Dijon

Institut de cancérologie de Bourgogne GRReCC, Dijon

Groupe Hospitalier Mutualiste, Grenoble

Chd Vendee, La Roche-sur-Yon

Hôpital Franco Britannique, Levallois-Perret

Hôpital Privé Le Bois, Lille

CHU Dupuytren, Limoges

Groupe Hospitalier Bretagne Sud, Lorient

Hôpital Jean Mermoz, Lyon

Chu La Timone, Marseille

Hôpital Européen, Marseille

CHRU, Nancy

Gh Nord Essone, Orsay

Chu Cochin, Paris

HEGP, Paris

Montsouris, Paris

Saint-Louis, Paris

Centre Hospitalier, Pau

CHU Haut Leveque, Pessac

Centre Cario, Plérin

Chu La Miletrie, Poitiers

CH Quimper Concarneau, Quimper

Cac Jean Godinot, Reims

Chu Robert Debré, Reims

Centre Hospitalier, Saint-Denis

Hôpital Privé, Saint-Grégoire

Hia Begin, Saint-Mandé

Groupe Hospitalier Rance Emeraude, St-Malo

Clinique Sainte-Anne, Strasbourg

ICANS, Strasbourg

CHRU Trousseau, Tours

Hôpital Nord Ouest, Villefranche-sur-Saône

Saint Joseph Hospital Bochum, Bochum

Krankenhaus Nordwest-CH Frankfurt Am Main, Frankfurt

Universitätsmedizin Göttingen CHU, Göttingen

Hämatologisch Onkologische Praxis Eppendorf, Hamburg

Centro Di Riferimento Oncologico Di Aviano, Aviano

Azienda Ospedaliero Universitaria Policlinico Rodolico San Marco Di Catania, Catania

Azienda Ospedaliero Universitaria Careggi, Florence

Azienda Unita Sanitaria Locale 6 Livorno, Livorno

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola

Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan

Azienda Ospedaliero-Universitatia Di Cagliari, Monserrato

Istituto Oncologico Veneto, Padua

Azienda Ospedaliero-Universitaria Pisana, Pisa

Azienda USL Toscana Centro, Prato

Azienda Unita Sanitaria Locale Della Romagna, Ravenna

Azienda Ospedaliera Policlinico Universitario Tor Vergata, Roma

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

Casa Sollievo Della Sofferenza, San Giovanni Rotondo

Azienda Ospedaliero-Universitaria Città della salute e della scienza di Torino Presidio Molinette, Torino

Pia Fondazione Di Culto E Religione Card Panico, Tricase

Azienda Sanitaria Universitaria Friuli Centrale, Udine

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario Reina Sofia, Córdoba

Instituto Catalan de Oncologia. Hospital Duran i Reynals, L'Hospitalet de Llobregat

Hospital Universitario Gregorio Maranon, Madrid

Hospital Universitario Central de Asturias, Oviedo

Hospital Universitario de Navarra, Pamplona

Hospital Clinico Universitario de Salamanca, Salamanca

Hospital Universitario Clinico San Carlos, San Carlos

Consorcio Hospital General Universitario de Valencia, Valencia

All Listed Sponsors
collaborator

Northwest Oncology Cooperative Group(GONO)

UNKNOWN

collaborator

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

collaborator

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

lead

Federation Francophone de Cancerologie Digestive

OTHER