Using patient-reported questionnaires to monitor quality of life during first-line chemo-immunotherapy for advanced NSCLC
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 (PROMOTING)
Run by IRCCS San Raffaele · NCT07061379 · Data updated 2026-11-12
This project will test whether regular online questionnaires about symptoms and quality of life can help track health and treatment effects in adults with stage IV NSCLC starting first-line chemo-immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | July 24, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2031 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT07061379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with stage IV NSCLC, PD-L1 <50%, no actionable genomic alterations, who are eligible for and about to start the specified first-line chemo-immunotherapy regimens and can complete online questionnaires are ideal candidates.
✕Probably not a fit
Patients unable to complete questionnaires due to neurological comorbidities, those with actionable genomic alterations, or those not receiving the specified chemo-immunotherapy regimens are unlikely to gain direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter national observational project will implement agreed European PROMs to collect patients' reports of quality of life, symptoms, physical function, mental health, sleep and sexuality in people with stage IV NSCLC receiving first-line chemo-immunotherapy. Participants will complete validated instruments (EORTC QLQ-C30, EORTC QLQ-LC13, PHQ-9, GAD-7) before treatment, after 4 and 8 cycles, and at disease progression. Clinical data including oncologic history, treatments given (platinum/pemetrexed plus anti–PD-1/PD-L1 regimens or combinations with CTLA-4 inhibitors), and imaging responses will be recorded alongside PROMs. As an observational effort it does not change standard-of-care treatment but seeks to standardize PROMs collection and explore links between patient-reported outcomes and clinical course.
Why it matters
Potential benefit: If successful, integrating routine PROMs could help tailor care, improve symptom management, and inform treatment choices to preserve quality of life for patients on first-line chemo-immunotherapy.
How similar studies have gone: PROMs have been used in oncology and shown improved symptom detection and associations with outcomes, but routine use to guide first-line chemo-immunotherapy decisions in NSCLC remains relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- Patients unable to fill the questionnaires due to neurological comorbidities
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Italy, Italy Recruiting
Study contacts
- Study coordinator: Sara Oresti, Medical Oncologist
- Email: oresti.sara@hsr.it
- Phone: +39 022643 8195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.