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)

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: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung

• Study Type: Observational
• Enrollment (Estimated): 825

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Study Connect Contact Center http://www.bmsstudyconnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Germany
  • Leipzig, Germany, 04277
    • Recruiting
    • Local Institution - 0001
    • Contact: Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Number of groups / cohorts

1

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)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) according to subgroups of interest		Up to 5 years
Progression-free survival (PFS)		Up to 5 years
Duration of treatment		Up to 5 years
Distribution of socio-demographic characteristics of participants	Age, Sex, Ethnicity, Height, Weight and BMI	At Baseline
Distribution of clinical characteristics of participants	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		Up to 5 years
Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)		Up to 5 years
Management of AEs: Treatment of AEs		Up to 5 years
Management of AEs: Date of occurrence of AE		Up to 5 years
Management of AEs: Start of treatment		Up to 5 years
Treatment Patterns: Previous therapies		Up to 5 years
Treatment Patterns: Subsequent therapies		Up to 5 years
Treatment patterns: Concomitant medication		Up to 5 years
Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies		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): 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: March 10, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Nivolumab; Metastatic; Ipilimumab; Chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CA209-7MA