A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (FINN)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Nivolumab + ipilimumab

• Study Type: Observational
• Enrollment (Actual): 404

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants receiving first-line nivolumab plus ipilimumab	Drug: Nivolumab + ipilimumab; As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Best overall response rate (BORR)	Up to 5 years
Best overall response (BOR)	Up to 5 years
Time to response (TTR)	Up to 5 years
Duration of response (DOR)	Up to 5 years
Overall response rate (ORR)	Up to 5 years
Progression-free survival (PFS)	Up to 5 years
Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria	Up to 5 years
European Quality of Life-5 Dimensions (EQ-5D) Score	Baseline and up to 5 years
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results	Baseline and up to 5 years
Treatment regimen	Up to 5 years
Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results	Baseline
Number of participants discontinuing treatment	Up to 5 years
Management of Adverse Events (AEs)	Up to 5 years
Participant socio-demographic characteristics	Baseline and up to 5 years
Participant clinical characteristics	Baseline and up to 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): October 11, 2030
• Study Completion (Estimated): October 11, 2030

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer (NSCLC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA209-1409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No