Actively Recruiting
Study of Antitumor Immune Response After Concurrent Chemo-radiotherapy and Immunotherapy in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World
Led by Fundación GECP · Updated on 2026-01-28
50
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the antitumor immune response in patients with unresectable non-small cell lung cancer (NSCLC) at stages IIIA, IIIB, and IIIC, all having PD-L1 expression greater than 1%. The study focuses on those receiving immunotherapy (IO) after concurrent chemo-radiotherapy (cCRT) without disease progression. It is an observational, multicenter, non-comparative study using real-world data collected retrospectively from patient medical records. The study does not provide any study-specific treatment; instead, patients receive standard clinical care including immunotherapy with Durvalumab following cCRT. Blood samples and tumor analyses will be collected as part of routine care and retrospectively reviewed. The duration of observation is expected to be three years, focusing on patients treated as per their hospital's usual clinical practice. Participants' clinical data and biological samples will be analyzed to measure overall survival and progression-free survival at 12, 18, 24, and 36 months. Additional assessments include evaluating the relationship between circulating tumor DNA clearance after immunotherapy and survival outcomes. No investigational drugs or procedures are administered by the study team. Participants will be monitored through their regular clinical visits and follow-up care.
CONDITIONS
Brief Title
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed unresectable NSCLC stage IIIA, IIIB, or IIIC
- PD-L1 expression greater than 1%
- Age 18 years or older at time of study
- ECOG performance status of 0 or 1
- Patients without progression after concurrent chemo-radiotherapy
- Patients scheduled to receive immunotherapy (Durvalumab) for 12 months as standard care
- Ability to comply with treatment and follow-up
- Signed informed consent form approved by ethics committee
You will not qualify if you...
- Patients who refuse to sign informed consent
- Inability to have venipuncture
- Any medical, mental, or psychological condition that would prevent study completion or understanding of study information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who undergo routine care with chemo-radiotherapy and immunotherapy are observed through collection of clinical data and samples.
Data collected retrospectively from clinical charts; timing of sample collection varies per routine care
Trial Site Locations
Total: 22 locations
1
Complejo Hospitalario Universitario Del Ferrol
Ferrol, A Coruña, Spain, 15405
Actively Recruiting
2
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
3
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
4
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
5
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041
Actively Recruiting
6
Hospital De Basurto
Bilbao, Bilbao, Spain, 48013
Actively Recruiting
7
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, Spain, 13005
Actively Recruiting
8
ICO Girona, Hospital Josep Trueta
Girona, Girona, Spain, 17007
Actively Recruiting
9
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Actively Recruiting
10
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Actively Recruiting
11
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003
Actively Recruiting
12
Hospital Universitario De La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
13
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
14
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
15
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
16
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
17
Hospital Universitario Central De Asturias
Oviedo, Oviedo, Spain, 33011
Actively Recruiting
18
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
19
Hospital Virgen del Rocio
Seville, Sevilla, Spain, 41013
Actively Recruiting
20
Hospital Universitario Y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
21
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
22
Complexo Hospitalario Universitario De Vigo
Vigo, Vigo, Spain, 36204
Actively Recruiting
Research Team
E
Eva Pereira
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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