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.

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).

• ECOG 0-1.

• PDL1\>1%.

• Age ≥ 18 years at time of study

• Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice

• Patient capable of proper therapeutic compliance and accessible for correct follow-up.

• Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines.

Locations
Other Locations
Spain
Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital General Universitario de Alicante
RECRUITING
Alicante
ICO Badalona, Hospital Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d' Hebron
NOT_YET_RECRUITING
Barcelona
Hospital De Basurto
RECRUITING
Bilbao
Hospital General Universitario de Ciudad Real
NOT_YET_RECRUITING
Ciudad Real
Complejo Hospitalario Universitario Del Ferrol
NOT_YET_RECRUITING
Ferrol
ICO Girona, Hospital Josep Trueta
RECRUITING
Girona
Hospital Universitari de Gran Canària Doctor Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario De La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Majadahonda
Hospital Universitario Central De Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Universitario Nuestra Señora de Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Virgen del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitario Y Politécnico La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
NOT_YET_RECRUITING
Valladolid
Complexo Hospitalario Universitario De Vigo
RECRUITING
Vigo
Contact Information
Primary
Eva Pereira
gecp@gecp.org
+34934302006
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2027-11-04
Participants
Target number of participants: 50
Treatments
Observational Study Group
Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1\>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.
Sponsors
Leads: Fundación GECP

This content was sourced from clinicaltrials.gov