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

Last updated: January 26, 2026
Sponsor: Fundación GECP
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Durvalumab

Clinical Study ID

NCT06634199
GECP 23/04_SIENNA
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • 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 correctfollow-up.

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

Exclusion

Exclusion Criteria:

  • Patients who refuse to sign and date an IRB/IEC-approved written informed consentform.

  • No possibility of venipuncture

  • Any medical, mental, or psychological condition which in the opinion of theinvestigator would not permit the patient to complete the study or understand thepatient information.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Durvalumab
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
November 04, 2027

Study Description

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.

Connect with a study center

  • Complejo Hospitalario Universitario Del Ferrol

    Ferrol, A Coruña 15405
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario Del Ferrol

    Ferrol 3123493, A Coruña 15405
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante 2521978, Alicante 03010
    Spain

    Active - Recruiting

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona 3129028, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona 3128760, Barcelona 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, Barcelona 08041
    Spain

    Active - Recruiting

  • Hospital De Basurto

    Bilbao 3128026, Bilbao 48013
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real 2519402, Ciudad Real 13005
    Spain

    Active - Recruiting

  • ICO Girona, Hospital Josep Trueta

    Girona 3121456, Girona 17007
    Spain

    Active - Recruiting

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña 15006
    Spain

    Site Not Available

  • Hospitalario Universitario A Coruña

    A Coruña 3119841, La Coruña 15006
    Spain

    Active - Recruiting

  • Hospital Universitari de Gran Canària Doctor Negrín

    Las Palmas De Gran Canaria, Las Palmas 35010
    Spain

    Site Not Available

  • Hospital Universitari de Gran Canària Doctor Negrín

    Las Palmas de Gran Canaria 2515270, Las Palmas 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo 3117814, Lugo 27003
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Active - Recruiting

  • Hospital Universitario De La Princesa

    Madrid 3117735, Madrid 3117732 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, Madrid 3117732 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Central De Asturias

    Oviedo 3114711, Oviedo 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife 2511174, Santa Cruz de Tenerife 38010
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio

    Seville 2510911, Sevilla 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid 3106672, Valladolid 47003
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario De Vigo

    Vigo 3105976, Vigo 36204
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitari Vall d' Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital De Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Site Not Available

  • ICO Girona, Hospital Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario De La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Central De Asturias

    Oviedo, 33011
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife, 38010
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario De Vigo

    Vigo, 36204
    Spain

    Site Not Available

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