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Clinical Trials in the USA / NCT06252649
Recruiting Phase 3

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

NCT06252649 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-07-17
Last updated
2026-09-03

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

FOLFIRI RegimenSotorasibPanitumumabBevacizumab-awwb

FOLFIRI Regimen: Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

Sotorasib: Immediate-release solid dosage form administered orally.

Panitumumab: Administered via IV infusion Q2W.

Bevacizumab-awwb: Administered via IV infusion Q2W.

Study summary

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection of KRAS p.G12C mutation. * Measurable metastatic disease per RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. Exclusion Criteria: * Active, untreated brain metastases. * Leptomeningeal disease * Previous treatment with a KRAS p.G12C inhibitor * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Primary outcome measure(s)

Trial sites (291)

FacilityCityRegionStatus
Ironwood Cancer and Research Centers Scottsdale Chandler Arizona Recruiting
Providence Saint Jude Medical Center Fullerton California Terminated
City of Hope National Medical Center Long Beach California Recruiting
Cancer and Blood Research Center, LLC Los Alamitos California Recruiting
California Research Institute Los Angeles California Terminated
Norwalk Hospital Norwalk Connecticut Terminated
Cancer Specialists of North Florida - Southpoint Jacksonville Florida Recruiting
D and H Cancer Research Center Margate Florida Terminated
Mid Florida Hematology and Oncology Centers PA Orange City Florida Terminated
Boca Raton Clinical Research Medical Center Inc Plantation Florida Terminated
Georgia Cancer Specialists Atlanta Georgia Terminated
Insight Research Institute Chicago Illinois Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Terminated
Orchard Healthcare Research Inc Skokie Illinois Terminated
Pikeville Medical Center Pikeville Kentucky Recruiting
Henry Ford Health System Detroit Michigan Terminated
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan Recruiting
Saint Louis Cancer Care West County Bridgeton Missouri Terminated
Minniti Center for Medical Oncology and Hematology Mickleton New Jersey Terminated
Duke Cancer Center Durham North Carolina Recruiting
FirstHealth Cancer Center Pinehurst North Carolina Terminated
Thomas Jefferson University Philadelphia Pennsylvania Terminated
Carolina Blood and Cancer Care Rock Hill South Carolina Terminated
Tennessee Oncology PLLC - Chattanooga Nashville Tennessee Recruiting
Tennessee Oncology, PLLC Nashville Tennessee Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Hospital Universitario Fundacion Favaloro CABA Buenos Aires Recruiting
Instituto Argentino de Diagnóstico y Tratamiento CABA Buenos Aires Recruiting
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL CABA Buenos Aires Recruiting
Cemic Ciudad Autonoma de Buenos Aires Buenos Aires Terminated
Sanatorio Británico de Rosario La Plata Buenos Aires Recruiting
Instituto de Investigaciones clinicas de Mar del Plata Mar del Plata Buenos Aires Recruiting
Hospital Italiano de Córdoba Córdoba Córdoba Province Recruiting
Sanatorio Allende Córdoba Córdoba Province Terminated
Clinica Universitaria Privada Reina Fabiola Córdoba Córdoba Province Recruiting
Clinica Viedma Viedma Río Negro Province Recruiting
Exelsus Oncologia Clinica San Miguel de Tucumán Tucumán Province Recruiting
Hospital Britanico de Buenos Aires Buenos Aires Argentina Recruiting
Centro Oncologico Riojano Integral La Rioja Argentina Terminated
Chris OBrien Lifehouse Camperdown New South Wales Recruiting

+ 251 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06252649 on ClinicalTrials.gov ↗ ← All trials in the USA