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

Recruiting now

Conditions studied: PROMs

In brief

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.

Key facts

Study ID

NCT07061379

Run by

IRCCS San Raffaele

People needed

144

Starts

2025-07-24

Expected to finish

2031-06-01

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Diagnosis of Stage IV NSCLC with PD-L1 <50%, without actionable genomic alterations
• Signed Informed Consent Form (ICF) to the study
• Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care

You may not qualify if…

• Patients unable to fill the questionnaires due to neurological comorbidities

Where it is running

• IRCCS Ospedale San Raffaele — Milan, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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