Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen

A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving. Specifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself. The study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression. Data will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT/PET reevaluations, any toxicities that arose during treatment.

NCT Number	NCT07061379
Lead Sponsor	IRCCS San Raffaele Collaborators: A.O.U. Città della Salute e della Scienza, Fondazione Policlinico Campus Bio-Medico, ASST Lariana, Como, IRCCS Istituto Nazionale dei Tumori, ASST Grande Ospedale Metropolitano Niguarda, IRCCS San Gerardo dei Tintori, Monza, Asst Degli Spedali Civili Di Brescia, Policlinico San Matteo Pavia, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Vincenzo Monaldi
Conditions	PROMs
Enrollment	144 participants
Start Date	2025-07-24
Primary Completion	2027-06 (estimated)
Study Completion	2031-06 (estimated)
Updated on ClinicalTrials.gov	2025-09-03