Actively Recruiting
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)
Led by IRCCS San Raffaele · Updated on 2025-09-03
144
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
A
AOU Città della Salute e della Scienza di Torino - Presidio Molinette
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of different first-line chemo-immunotherapy treatments on quality of life in patients with metastatic lung adenocarcinoma, specifically non-small-cell lung cancer (NSCLC) with PD-L1 expression below 50%. This observational study aims to use validated European-wide patient-reported outcome measures (PROMs) to understand how treatments affect patients' health, including physical function, mental health, sleep quality, sexuality, and overall well-being. The study also explores the effect of treatment-related toxicities and the time patients spend receiving healthcare, called "time toxicity." Participants receive one of two treatment regimens: Cohort A receives four cycles of Carboplatin or Cisplatin with Pemetrexed and Pembrolizumab or Cemiplimab, followed by maintenance therapy with Pemetrexed and Pembrolizumab or Cemiplimab for up to two years or until disease progression or unacceptable toxicity. Cohort B receives two cycles of Carboplatin or Cisplatin with Pemetrexed, Nivolumab, and Ipilimumab, followed by maintenance with Nivolumab every 21 days and Ipilimumab every 42 days for up to two years or until disease progression or unacceptable toxicity. These regimens are studied to compare their impact on patients' quality of life. During the study, patients will complete online questionnaires assessing various aspects of their health and quality of life before starting treatment, after 4 and 8 treatment cycles, and at disease progression. Data on medical history, treatment responses assessed by CT/PET scans, and any toxicities experienced will also be collected. Researchers will evaluate the primary outcome of quality of life after 4 cycles of treatment and secondary outcomes including overall survival and patient-reported measures at later timepoints. The study monitors patients' experiences over time to better understand treatment effects in real-world settings.
CONDITIONS
Brief Title
Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients unable to fill the questionnaires due to neurological comorbidities
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive one of two chemo-immunotherapy regimens as first line therapy for metastatic lung adenocarcinoma. Cohort A receives Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles followed by maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or until disease progression or unacceptable toxicity. Cohort B receives Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles followed by maintenance with Nivolumab every 21 days and Ipilimumab every 42 days up to 2 years or until disease progression or unacceptable toxicity.
Visits occur regularly for treatment cycles and maintenance dosing, with assessments after 4 and 8 cycles and at disease progression.
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
S
Sara Oresti, Medical Oncologist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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