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Active, Not Recruiting

NCT Number: NCT06487156

A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nivolumab + Ipilimumab

Drug

As per product label

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 5 years

  2. Overall response rate (ORR)

    Time frame: Up to 5 years

  3. Best overall response (BOR)

    Time frame: Up to 5 years

  4. Best overall response rate (BORR)

    Time frame: Up to 5 years

  5. Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Time frame: Up to 5 years

  6. Duration of response (DOR)

    Time frame: Up to 5 years

  7. Time to response (TTR)

    Time frame: Up to 5 years

  8. European Quality of Life-5 Dimensions (EQ-5D) Score

    Time frame: Baseline and up to 5 years

  9. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results

    Time frame: Baseline and up to 5 years

  10. Treatment regimen

    Time frame: Up to 5 years

  11. Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results

    Time frame: Baseline

  12. Number of participants discontinuing treatment

    Time frame: Up to 5 years

  13. Management of Adverse Events (AEs)

    Time frame: Up to 5 years

  14. Participant socio-demographic characteristics

    Time frame: Baseline and up to 5 years

  15. Participant clinical characteristics

    Time frame: Baseline and up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: FINN

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 5, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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