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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-03

Study Completion Date

2027-11-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1\>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer Stage III PDL1 Gene Mutation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lung Cancer Chemo radiotherapy ctDNA Inmunotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Durvalumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Durvalumab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Imfinzi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
* No possibility of venipuncture
* Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mariano Provencio, MD

Role: STUDY_CHAIR

Fundación GECP President

Reach out to these primary contacts for questions about participation or study logistics.

Eva Pereira

Role: CONTACT

Phone: +34934302006

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Observational Study Group

Durvalumab

Interventions

Durvalumab

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fundación GECP

Responsible Party

Principal Investigators

Mariano Provencio, MD

Locations

Complejo Hospitalario Universitario Del Ferrol

ICO Badalona, Hospital Germans Trias i Pujol

Hospitalario Universitario A Coruña

Hospital Universitari de Gran Canària Doctor Negrín

Hospital Universitario Puerta de Hierro

Hospital General Universitario de Alicante

Hospital Universitari Vall d' Hebron

Hospital de la Santa Creu i Sant Pau

Hospital De Basurto

Hospital General Universitario de Ciudad Real

ICO Girona, Hospital Josep Trueta

Hospital Universitario Lucus Augusti

Hospital Universitario De La Princesa

Hospital Clínico San Carlos

Hospital Universitario Fundación Jiménez Díaz

Hospital Universitario La Paz

Hospital Universitario Central De Asturias

Hospital Universitario Nuestra Señora de Candelaria

Hospital Virgen del Rocio

Hospital Universitario Y Politécnico La Fe

Hospital Clínico Universitario de Valladolid

Complexo Hospitalario Universitario De Vigo

Countries

Central Contacts

Eva Pereira

Facility Contacts

Javier Afonso Afonso, MD

Ainhoa Hernández, MD

Rosario García Campelo, MD

David Aguiar Bujanda, MD

Mariano Provencio, MD

Natividad Martínez-Banaclocha, MD

Patricia Iranzo, MD

Andrés Barba, MD

Mª Angeles Sala González, MD

Patricia Cruz, MD

Joaquim Bosch, MD

Begoña Campos, MD

Jose Miguel Sanchez Torres, MD

Carlos Aguado, MD

Manuel Dómine, MD

Javier de Castro, MD

Sena Valcárcel González, MD

Ana Cardeña Gutierrez, MD

Reyes Bernabé, MD

Oscar Juan, MD

Andrea Medina del Valle, MD

Martín Lazaro, MD

Related Links

Other Identifiers

GECP 23/04_SIENNA