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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04794010

Collaborator

(none)

825

Enrollment

Location

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung

Study Design

Study Type:

Observational

Anticipated Enrollment :

825 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 22, 2020

Anticipated Primary Completion Date :

Dec 22, 2027

Anticipated Study Completion Date :

Dec 22, 2027

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants with Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [Up to 5 years]

Secondary Outcome Measures

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 [At Baseline]
Age, Sex, Ethnicity, Height, Weight and BMI
Distribution of clinical characteristics of participants [At Baseline]
Histology subtype, Tumor stage, Location or primary tumor and Location of metastases
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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