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

RecruitingOBSERVATIONAL
Enrollment

144

Participants

Timeline

Start Date

July 24, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2031

Conditions
PROMs
Interventions
DRUG

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

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

DRUG

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

"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"

Trial Locations (1)

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

All Listed Sponsors
collaborator

AOU Città della Salute e della Scienza di Torino - Presidio Molinette

UNKNOWN

collaborator

Fondazione Policlinico Campus Bio-Medico

UNKNOWN

collaborator

ASST Lariana, Como

UNKNOWN

collaborator

IRCCS Istituto Nazionale dei Tumori

UNKNOWN

collaborator

ASST Grande Ospedale Metropolitano Niguarda

OTHER

collaborator

IRCCS San Gerardo dei Tintori, Monza

UNKNOWN

collaborator

ASST Spedali Civili di Brescia

UNKNOWN

collaborator

Policlinico San Matteo Pavia

UNKNOWN

collaborator

IRCCS Istituto Clinico Humanitas

UNKNOWN

collaborator

Ospedale Vincenzo Monaldi

UNKNOWN

lead

IRCCS San Raffaele

OTHER