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RECRUITING
NCT05398094
PHASE2

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Sponsor: Fundación GECP

View on ClinicalTrials.gov

Summary

Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.

Official title: Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2022-03-21

Completion Date

2028-12-31

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

DRUG

Sotorasib

AMG510 (Sotorasib) is small molecule that specifically and irreversibly inhibits the KRAS-G12C mutant protein. AMG510 (Sotorasib) finished product is presented as tablets containing 120mg and will be packaged in bottles of 120 tablets.

Locations (20)

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital de Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital Universitari Quiron Dexeus

Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Spain

Hospital Parc Taulí

Barcelona, Spain

Hospital De Basurto

Bilbao, Spain

ICO Girona, Hospital Josep Trueta

Girona, Spain

Hospital Clínico San Cecilio De Granada

Granada, Spain

Complejo Hospitalario De Jaén

Jaén, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitari Son Llatzer

Palma de Mallorca, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital General Universitario De Valencia

Valencia, Spain

Hospital Universitario La Fe

Valencia, Spain