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
NCT ID: NCT07124884
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-08-31
2030-12-30
Brief Summary
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Detailed Description
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The main inclusion and exclusion criteria are summarized in Table 1. Main inclusion criteria are patients ≥18 years old, with unresectable MSS/pMMR KRASG12C metastatic CRC histologically proven, with altered WHO Performance Status...
Eligible patients will receive LV5FU2 (a 400mg/m2 intravenous (IV) bolus of 5-FU at day 1 (D1) with 400mg/m2 of folinic acid, followed by a continuous 5-FU infusion of 2400mg/m2 over 46 hours) plus Panitumumab (6mg/kg IV at D1) and Sotorasib (960mg PO once daily, every day) in 2-week-cycles (Q2W) until progression or intolerance (cf Figure 1).
Adverse events requiring dose adjustment or treatment discontinuation will all be assessed using the NCI-CTCAE v5.0 scale and manage in accordance with the standard guidelines and the "Summaries of Product Characteristics".
The primary objective is to evaluate the progression-free survival (PFS) of 5FU plus Panitumumab and Sotorasib at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated CRC. The progression will be defined as the radiological progression according to RECIST v1.1 criteria assessed by the investigator. A centralized review of CT-scans will be performed to confirm RECIST 1.1 criteria.
Secondary objectives include median progression-free survival (mPFS), disease control rate (DCR), time to progression (TTP), overall survival (OS), best objective response rate (ORR), duration of response (DoR), safety profile, Quality of life (QoL) (with EORTC QLQC30 and FACIT-GP5 questionnaires), and Geriatric assessment (based on G8 score and " Geriatric COre Data sEt " (G-CODE)).
Toxicity will all be evaluated according to the National cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0) scale. A safety analysis will be done when 10 patients have been treated for at least 2 months to check the good tolerability of 5-FU plus Panitumumab and Sotorasib combination
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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5-fluorouracil plus Panitumumab and Sotorasib
Each patient receives one treatment cycle every two weeks until disease progression or unacceptable toxicity. 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.
* Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test
* Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
* Patient with one these criteria:
Patient with WHO PS=2 Patient between 70 and 75 years old with WHO PS 1 Patient ≥ 75 years old
* Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
* No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed if there is more than 6 months between the end of adjuvant treatment and relapse.
* Adequate organ function: Hemoglobin \> 9 g/dl, Absolute neutrophil count \> 1500 /mm3, Platelets \> 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN.
* Ability to understand and sign written informed consent to participate in the study.
* Provides written informed consent for the study.
* Life expectancy \>6 months.
* Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments.
* Patient affiliated to a social security scheme for France, or equivalent for other countries.
Exclusion Criteria
* Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume \<50%) severe insufficiency.
* Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).
* Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).
* Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL).
* Immunotherapy within 3 months before the beginning of the treatment study.
* Patient under treatment by strong CYP3A4 inducers.
* Patients treated by brivudine within 4 weeks before the first dose of study treatment, or concomitant treatment with brivudine.
* Patient with potentially serious infection.
* Administration of live or live attenuated vaccine within 30 days prior to the first dose of study treatment start.
* Poor nutritional state (albuminemia \< 25 g/L or weight loss \> 10% during the last month).
* Hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption.
* Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated.
* Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery.
* Patients with persistent toxicities related to prior treatment of grade greater than 1.Is c urrently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry.
* Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments.
* Patient with interstitial lung disease or pulmonary fibrosis.
* Patients with history of interstitial pneumonitis or pulmonary fibrosis.
* Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.
* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.
* Pregnant or breastfeeding woman.
* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
18 Years
ALL
No
Sponsors
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Northwest Oncology Cooperative Group(GONO)
UNKNOWN
Arbeitsgemeinschaft fur Internistische Onkologie
OTHER
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Locations
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ICO site Paul Papin
Angers, , France
Centre Hospitalier Annecy Genevois
Annecy, , France
Hôpital Privé
Antony, , France
Centre Hospitalier
Aurillac, , France
Centre Hospitalier
Bayeux, , France
Ch Cote Basque
Bayonne, , France
Ch Simone Veille
Beauvais, , France
Chu Jean Minjoz
Besançon, , France
Polyclinique Courlancy
Bezannes, , France
Centre Hospitalier Béthune Beuvry
Béthune, , France
Bordeaux Nord Aquitaine
Bordeaux, , France
TIVOLI
Bordeaux, , France
Chu Morvan
Brest, , France
CHU Côte de Nacre
Caen, , France
Centre Hospitalier
Cholet, , France
Hôpitaux civils
Colmar, , France
Polyclinique Saint-Côme
Compiègne, , France
Chu Francois Mitterand
Dijon, , France
Gf Leclerc
Dijon, , France
Institut de cancérologie de Bourgogne GRReCC
Dijon, , France
Groupe Hospitalier Mutualiste
Grenoble, , France
Chd Vendee
La Roche-sur-Yon, , France
Hôpital Franco Britannique
Levallois-Perret, , France
Hôpital Privé Le Bois
Lille, , France
CHU Dupuytren
Limoges, , France
Groupe Hospitalier Bretagne Sud
Lorient, , France
Hôpital Jean Mermoz
Lyon, , France
Chu La Timone
Marseille, , France
Hôpital Européen
Marseille, , France
CHRU
Nancy, , France
Gh Nord Essone
Orsay, , France
Chu Cochin
Paris, , France
HEGP
Paris, , France
Montsouris
Paris, , France
Saint-Louis
Paris, , France
Centre Hospitalier
Pau, , France
CHU Haut Leveque
Pessac, , France
Centre Cario
Plérin, , France
Chu La Miletrie
Poitiers, , France
CH Quimper Concarneau
Quimper, , France
Cac Jean Godinot
Reims, , France
Chu Robert Debré
Reims, , France
Centre Hospitalier
Saint-Denis, , France
Hôpital Privé
Saint-Grégoire, , France
Hia Begin
Saint-Mandé, , France
Groupe Hospitalier Rance Emeraude
St-Malo, , France
Clinique Sainte-Anne
Strasbourg, , France
ICANS
Strasbourg, , France
CHRU Trousseau
Tours, , France
Hôpital Nord Ouest
Villefranche-sur-Saône, , France
Saint Joseph Hospital Bochum
Bochum, , Germany
Krankenhaus Nordwest-CH Frankfurt Am Main
Frankfurt, , Germany
Universitätsmedizin Göttingen CHU
Göttingen, , Germany
Hämatologisch Onkologische Praxis Eppendorf
Hamburg, , Germany
Centro Di Riferimento Oncologico Di Aviano
Aviano, , Italy
Azienda Ospedaliero Universitaria Policlinico Rodolico San Marco Di Catania
Catania, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Azienda Unita Sanitaria Locale 6 Livorno
Livorno, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, , Italy
Azienda Ospedaliero-Universitatia Di Cagliari
Monserrato, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Azienda USL Toscana Centro
Prato, , Italy
Azienda Unita Sanitaria Locale Della Romagna
Ravenna, , Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliero-Universitaria Città della salute e della scienza di Torino Presidio Molinette
Torino, , Italy
Pia Fondazione Di Culto E Religione Card Panico
Tricase, , Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, , Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Instituto Catalan de Oncologia. Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Clinico San Carlos
San Carlos, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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Facility Contacts
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Oliver GOTZE Thorsten
Role: primary
Ute Margarethe KONIG
Role: primary
Luisa FOLTRAN
Role: primary
Giuseppe NOVELLO
Role: primary
Lorenzo ANTONUZZO
Role: primary
Giacomo ALLEGRINI
Role: primary
Alessandro PASSARDI
Role: primary
Filippo PIETRANTONIO
Role: primary
Mario SCARTOZZI
Role: primary
Francesca BERGAMO
Role: primary
Roberto MORETTO
Role: primary
Samantha DI DONATO
Role: primary
Stefano TAMBERI
Role: primary
Vincenzo FORMICA
Role: primary
Lisa SALVATORE
Role: primary
Tiziana PIA LATIANO
Role: primary
Massimo DI MAIO
Role: primary
Emiliano TAMBURINI
Role: primary
Valentina FANOTTO
Role: primary
Maria del Rosario Vidal Tocino
Role: primary
Javier Sastre Valera
Role: primary
Other Identifiers
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2024-514030-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
PRODIGE 107-ENGIC01-COLOSOTO
Identifier Type: -
Identifier Source: org_study_id
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