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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Complejo Hospitalario Universitario Del Ferrol
Ferrol, A Coruña, Spain
RECRUITINGHospital General Universitario de Alicante
Alicante, Alicante, Spain
RECRUITINGICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGHospital De Basurto
Bilbao, Bilbao, Spain
RECRUITINGHospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, Spain
RECRUITINGICO Girona, Hospital Josep Trueta
Girona, Girona, Spain
RECRUITINGHospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
RECRUITINGHospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
RECRUITING...and 12 more locations
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
Time frame: 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
Time frame: To evaluate the Progression-free survival at 12, 18, 24 and 36 months
Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).
Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS
Time frame: From date of end of treatment until the date of last follow up, assessed up to 36 months
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