Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
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.
Fundación GECP
50 participants
Oct 3, 2024
OBSERVATIONAL
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.
Eligibility
Inclusion Criteria7
- 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 Criteria3
- 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.
Interventions
Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT06634199