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

NCT07061379 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-09-03

No results posted yet for this study

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.

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Fondazione Policlinico Campus Bio-Medico

    collaborator UNKNOWN

  • ASST Lariana, Como

    collaborator UNKNOWN

  • IRCCS Istituto Nazionale dei Tumori

    collaborator UNKNOWN

  • ASST Grande Ospedale Metropolitano Niguarda

    collaborator OTHER

  • IRCCS San Gerardo dei Tintori, Monza

    collaborator UNKNOWN

  • ASST Spedali Civili di Brescia

    collaborator UNKNOWN

  • Policlinico San Matteo Pavia

    collaborator UNKNOWN

  • IRCCS Istituto Clinico Humanitas

    collaborator UNKNOWN

  • Ospedale Vincenzo Monaldi

    collaborator UNKNOWN

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2027-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061379 on ClinicalTrials.gov