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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with Metastatic Non-Small Cell Lung Cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, NSCLC, Nivolumab, Ipilimumab, Chemotherapy, Metastatic