Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
- Conditions
- Non-small Cell Lung Cancer Stage IIIPDL1 Gene Mutation
- Interventions
- Registration Number
- NCT06634199
- Lead Sponsor
- Fundación GECP
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Study Group Durvalumab 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.
- Primary Outcome Measures
Name Time Method Overall survival (OS) To evaluate the Overall Survival at 12, 18, 24 and 36 months 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
Progression-free survival (PFS) To evaluate the Progression-free survival at 12, 18, 24 and 36 months 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
- Secondary Outcome Measures
Name Time Method 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 Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS
Trial Locations
- Locations (22)
Complejo Hospitalario Universitario Del Ferrol
🇪🇸Ferrol, A Coruña, Spain
ICO Badalona, Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospitalario Universitario A Coruña
🇪🇸A Coruña, La Coruña, Spain
Hospital Universitari de Gran Canària Doctor Negrín
🇪🇸Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitari Vall d' Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital De Basurto
🇪🇸Bilbao, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
ICO Girona, Hospital Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario De La Princesa
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Central De Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Complexo Hospitalario Universitario De Vigo
🇪🇸Vigo, Spain