A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer (FINN)

December 9, 2024 updated by: Bristol-Myers Squibb

A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer

The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.

The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).

Study Overview

Status

Active, not recruiting

Conditions

Carcinoma, Non-Small-Cell Lung

Study Type

Observational

Enrollment (Estimated)

825

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Leipzig, Germany, 04277
    - Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards.

The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).

Description

Inclusion Criteria:

Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study

Exclusion Criteria:

Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
Participants with known EGFR- or ALK-alterations

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort 1 Participants with Metastatic Non-Small Cell Lung Cancer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) according to subgroups of interest Time Frame: Up to 5 years		Up to 5 years
Progression-free survival (PFS) Time Frame: Up to 5 years		Up to 5 years
Duration of treatment Time Frame: Up to 5 years		Up to 5 years
Distribution of socio-demographic characteristics of participants Time Frame: At Baseline	Age, Sex, Ethnicity, Height, Weight and BMI	At Baseline
Distribution of clinical characteristics of participants Time Frame: At Baseline	Histology subtype, Tumor stage, Location or primary tumor and Location of metastases	At Baseline
Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires Time Frame: Up to 5 years		Up to 5 years
Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Time Frame: Up to 5 years		Up to 5 years
Management of AEs: Treatment of AEs Time Frame: Up to 5 years		Up to 5 years
Management of AEs: Date of occurrence of AE Time Frame: Up to 5 years		Up to 5 years
Management of AEs: Start of treatment Time Frame: Up to 5 years		Up to 5 years
Treatment Patterns: Previous therapies Time Frame: Up to 5 years		Up to 5 years
Treatment Patterns: Subsequent therapies Time Frame: Up to 5 years		Up to 5 years
Treatment patterns: Concomitant medication Time Frame: Up to 5 years		Up to 5 years
Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies Time Frame: Up to 5 years		Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

BMS Clinical Trial Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Estimated)

December 22, 2027

Study Completion (Estimated)

December 22, 2027

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria