Clinical trial NCT06487156: A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small cell lung cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment

Brief summary: The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
* Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
* Patient is at least 18 years of age at time of treatment decision
* Patient provided written informed consent to participate in the study

Exclusion Criteria:

* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
* Patients with known EGFR- or ALK-alterations
* Previous treatment with nivolumab and/or ipilimumab
* Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
measure: Overall response rate (ORR)
timeFrame: Up to 5 years
measure: Best overall response (BOR)
timeFrame: Up to 5 years
measure: Best overall response rate (BORR)
timeFrame: Up to 5 years
measure: Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria
timeFrame: Up to 5 years
measure: Duration of response (DOR)
timeFrame: Up to 5 years
measure: Time to response (TTR)
timeFrame: Up to 5 years
measure: European Quality of Life-5 Dimensions (EQ-5D) Score
timeFrame: Baseline and up to 5 years
measure: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results
timeFrame: Baseline and up to 5 years
measure: Treatment regimen
timeFrame: Up to 5 years
measure: Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results
timeFrame: Baseline
measure: Number of participants discontinuing treatment
timeFrame: Up to 5 years
measure: Management of Adverse Events (AEs)
timeFrame: Up to 5 years
measure: Participant socio-demographic characteristics
timeFrame: Baseline and up to 5 years
measure: Participant clinical characteristics
timeFrame: Baseline and up to 5 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: