Clinical trial NCT06634199: Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
Official title: Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer Stage III
PDL1 Gene Mutation
Keywords: Lung Cancer
Chemo radiotherapy
ctDNA
Inmunotherapy
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: To evaluate the Overall Survival at 12, 18, 24 and 36 months
measure: Progression-free survival (PFS)
timeFrame: To evaluate the Progression-free survival at 12, 18, 24 and 36 months
Secondary outcomes:
measure: Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).
timeFrame: From date of end of treatment until the date of last follow up, assessed up to 36 months
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario Del Ferrol
state: A Coruña
city: Badalona
country: Spain
facility: ICO Badalona, Hospital Germans Trias i Pujol
state: Barcelona
city: A Coruña
country: Spain
facility: Hospitalario Universitario A Coruña
state: La Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitari de Gran Canària Doctor Negrín
state: Las Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital De Basurto
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Girona
country: Spain
facility: ICO Girona, Hospital Josep Trueta
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario De La Princesa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central De Asturias
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario Y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario De Vigo
Study officials:
affiliation: Fundación GECP President
name: Mariano Provencio, MD
role: STUDY_CHAIR
References: