Actively Recruiting

Age: 18Years +
All Genders
NCT07061379

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

Led by IRCCS San Raffaele · Updated on 2025-09-03

144

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

Sponsors

I

IRCCS San Raffaele

Lead Sponsor

A

AOU Città della Salute e della Scienza di Torino - Presidio Molinette

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Diagnosis of Stage IV NSCLC with PD-L1 <50%, without actionable genomic alterations
  • Signed Informed Consent Form (ICF) to the study
  • Eligible to receive first-line combo chemo-immunotherapy treatments as standard care
Not Eligible

You will not qualify if you...

  • Unable to fill in questionnaires due to neurological comorbidities

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, Italy, Italy, 20132

Actively Recruiting

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Research Team

S

Sara Oresti, Medical Oncologist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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