RecruitingNCT06634199

Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.

Sponsor

Fundación GECP

Enrollment

50 participants

Start Date

Oct 3, 2024

Study Type

OBSERVATIONAL

Conditions

PDL1 Gene Mutation Non-Small Cell Lung Cancer (Stage III)

Summary

Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the immune system responds in patients with advanced, inoperable non-small cell lung cancer (NSCLC) who are being treated with a combination of chemotherapy and radiation (chemoradiation), followed by an immunotherapy drug called durvalumab. The goal is to understand the biology behind why some patients respond well and others do not, using blood samples taken at different points during treatment. **You may be eligible if...** - You have been diagnosed with inoperable stage IIIA, IIIB, or IIIC non-small cell lung cancer (confirmed by tissue biopsy) - Your tumor expresses the PD-L1 protein (above 1%) - You are 18 or older with an ECOG performance status of 0–1 (active and able to carry out everyday activities) - You did not progress after chemoradiation and are about to start durvalumab immunotherapy for 12 months - You are able and willing to have blood drawn as part of the study **You may NOT be eligible if...** - You refuse to sign the informed consent - A blood draw is not medically feasible - You have a physical, mental, or psychological condition preventing you from completing the study 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

DRUGDurvalumab

Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital

Locations(22)

Complejo Hospitalario Universitario Del Ferrol

Ferrol, A Coruña, Spain

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital De Basurto

Bilbao, Bilbao, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain

ICO Girona, Hospital Josep Trueta

Girona, Girona, Spain

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitari de Gran Canària Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Universitario De La Princesa

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Central De Asturias

Oviedo, Oviedo, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Hospital Virgen del Rocio

Seville, Sevilla, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Complexo Hospitalario Universitario De Vigo

Vigo, Vigo, Spain

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NCT06634199

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Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(22)

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