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

Fundación GECP

Status: Enrolling

Conditions: PDL1 Gene Mutation; Non-small Cell Lung Cancer Stage III

Treatments: Drug: Durvalumab

Study type: Observational

Funder types: Other

Identifiers

NCT06634199

GECP 23/04_SIENNA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Observational Study Group

Description:

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.

Treatment:

Drug: Durvalumab