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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04794010

Acronym

FINN

Enrollment

825

Registered

2021-03-11

Start date

2020-12-22

Completion date

2027-12-22

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer, NSCLC, Nivolumab, Ipilimumab, Chemotherapy, Metastatic

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

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/

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	Up to 5 years

Secondary

Measure	Time frame	Description
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	—
Overall Survival (OS) according to subgroups of interest	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	—
Management of AEs: Treatment of AEs	Up to 5 years	—

Countries

Germany

Outcome results