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

N/AActive Not RecruitingNCT04794010

Bristol-Myers Squibb825 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

825

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: Up to 5 years

Secondary Outcomes

Overall Survival (OS) according to subgroups of interest

Time frame: Up to 5 years

Progression-free survival (PFS)

Time frame: Up to 5 years

Duration of treatment

Time frame: Up to 5 years

Distribution of socio-demographic characteristics of participants

Age, Sex, Ethnicity, Height, Weight and BMI

Time frame: At Baseline

Distribution of clinical characteristics of participants

Histology subtype, Tumor stage, Location or primary tumor and Location of metastases

Time frame: 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

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

Management of AEs: Treatment of AEs

Time frame: Up to 5 years

Management of AEs: Date of occurrence of AE

Time frame: Up to 5 years

Management of AEs: Start of treatment

Time frame: Up to 5 years

Treatment Patterns: Previous therapies

Time frame: Up to 5 years

Treatment Patterns: Subsequent therapies

Time frame: Up to 5 years

Treatment patterns: Concomitant medication

Time frame: Up to 5 years

Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies

Time frame: Up to 5 years