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

Recruitingn/aAges 18 Years - anyAllIRCCS San Raffaele
NCT07061379 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity
  • Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity
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Where

1 site
IRCCS Ospedale San Raffaele
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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