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

ConditionPROMs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • 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

Treatment groups

144 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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