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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Sara Oresti, Medical Oncologist
oresti.sara@hsr.it
+39 022643 8195
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2031-06
Participants
Target number of participants: 144
Treatments
Cohort A: patient treated with chemo-ICI regimen as first line therapy
Cohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity
Cohort B: patient treated with double ICI-chemo regimen as first line therapy
Cohort B:~Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity
Related Therapeutic Areas
Sponsors
Collaborators: ASST Spedali Civili di Brescia, IRCCS San Gerardo dei Tintori, Monza, ASST Grande Ospedale Metropolitano Niguarda, Fondazione Policlinico Campus Bio-Medico, IRCCS Istituto Nazionale dei Tumori, Policlinico San Matteo Pavia, ASST Lariana, Como, Ospedale Vincenzo Monaldi, AOU Città della Salute e della Scienza di Torino - Presidio Molinette, IRCCS Istituto Clinico Humanitas
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov