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.
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
None
Patients with diagnosis of unresectable or advanced NSCLC eligible for first line chemo- ICI (Cohort A) or double ICI-chemo (Cohort B) regimens. Up to 50 patients with squamous histology, treated with any chemo- immunotherapy scheme will be monitored for QoL parameters as a prospective exploratory observational cohort and will not be included in the sample size calculation.
Cohort
Prospective
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
DrugCohort 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
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
DrugCohort 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
To evaluate what kind of first line treatment for metastatic lung adenocarcinoma has a better impact on quality of life of the patients
QoL domains assessed by EORTC QLQ-C-30 and LC13 at baseline and after 4 cycles. All questionnaires used in this study are validated questionnaires
To assess the impact on overall survival of all the PROMs items under investigation
* QoL domains assessed by EORTC QLQ-C-30 and LC13 after 8 cycles of treatment and at disease progression * Sleep (PSQI), emotional stress (PHQ-9, GAD 7-item scale), sexual health ((EORTC QLQ-SH- 22) and time toxicity after 4 cycles, 8 cycles, and at disease progression * Overall Survival
- To assess the impact on overall survival of all the PROMs items under investigation in squamous NSCLC
QoL domains assessed by EORTC QLQ-C-30 and LC13 between double ICI-chemo or chemo- ICI regimens in patients with metastatic squamous NSCLC after 4 cycles, 8 cycles, and at disease progression.
- To assess the impact on PFS and RR in patients receiving different first line regimens
Progression-Free Survival (PFS) and Response Rate (RR) in each Cohort
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IRCCS San Raffaele
Lead sponsor
AOU Città della Salute e della Scienza di Torino - Presidio Molinette
Collaborator
Fondazione Policlinico Campus Bio-Medico
Collaborator
ASST Lariana, Como
Collaborator
IRCCS Istituto Nazionale dei Tumori
Collaborator
ASST Grande Ospedale Metropolitano Niguarda
Collaborator
IRCCS San Gerardo dei Tintori, Monza
Collaborator
Asst Degli Spedali Civili Di Brescia
Collaborator
Policlinico San Matteo Pavia
Collaborator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborator
Ospedale Vincenzo Monaldi
Collaborator
