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

NCT06634199 | Recruiting

• 1 other identifier: GECP 23/04_SIENNA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Non-small Cell Lung Cancer Stage III; PDL1 Gene Mutation

Keywords

Lung Cancer; Chemo radiotherapy; ctDNA; Inmunotherapy

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  Defined from the date of diagnosis to death from any cause. Patients alive at the end of follow-up or lost to follow-up are censored at the last contact time. The probability of remaining free of events at specific timepoints

  To evaluate the Overall Survival at 12, 18, 24 and 36 months

• Progression-free survival (PFS)

  Defined from the diagnosis date to the date of investigator-determined disease relapse or death, whichever occurs first. The probability of remaining free of events at specific timepoints

  To evaluate the Progression-free survival at 12, 18, 24 and 36 months

Secondary Outcomes (1)

• Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).

  From date of end of treatment until the date of last follow up, assessed up to 36 months

Study Arms (1)

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.

Drug: Durvalumab

Interventions

Durvalumab DRUG

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

Also known as: Imfinzi

Observational Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (22)

Complejo Hospitalario Universitario Del Ferrol

Ferrol, A Coruña, 15405, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Hospital De Basurto

Bilbao, Bilbao, 48013, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

RECRUITING

ICO Girona, Hospital Josep Trueta

Girona, Girona, 17007, Spain

RECRUITING

Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Hospital Universitari de Gran Canària Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Hospital Universitario De La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Central De Asturias

Oviedo, Oviedo, 33011, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

RECRUITING

Hospital Virgen del Rocio

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitario Y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

Complexo Hospitalario Universitario De Vigo

Vigo, Vigo, 36204, Spain

RECRUITING

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor samples Routine Blood samples extraction

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariano Provencio, MD

  Fundación GECP President

  STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006; gecp@gecp.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (22)