RecruitingPhase 2NCT05398094

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

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

Sponsor

Fundación GECP

Enrollment

19 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sotorasib (AMG510), a targeted drug, for people with inoperable Stage III lung cancer that has a specific gene mutation called KRAS G12C — and who cannot tolerate or are not suitable for standard chemo-radiation therapy. **You may be eligible if...** - You are 80 years old or younger - You have been diagnosed with inoperable Stage III non-small cell lung cancer (NSCLC) - Your cancer has the KRAS G12C mutation, confirmed by a certified lab - You are not a candidate for standard chemoradiation therapy - You are well enough to carry out daily activities (ECOG status 0–1) **You may NOT be eligible if...** - Your cancer has spread beyond the chest - You have previously received KRAS-targeted therapy - You have active brain metastases - You have significant heart or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSotorasib

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)

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, Spain

Hospital Parc Taulí

Barcelona, Barcelona, Spain

Hospital De Basurto

Bilbao, Bilbao, Spain

ICO Girona, Hospital Josep Trueta

Girona, Girona, Spain

Hospital Clínico San Cecilio De Granada

Granada, Granada, Spain

Complejo Hospitalario De Jaén

Jaén, Jaén, Spain

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital de Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, Spain

Hospital Universitario Virgen Del Rocio

Seville, Sevilla, Spain

Hospital General Universitario De Valencia

Valencia, Valencia, Spain

Hospital Universitario La Fe

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT05398094