Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy

Study Overview
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Brief Summary
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This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.

Official Title
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A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician Males and Females, ≥18 years of age Exclusion Criteria: Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment. Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed) Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known) Other protocol defined inclusion/exclusion criteria could 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 |
| --- | --- |
| NSCLC patients with squamous tumor histology<br> | |
| NSCLC patients with non-squamous tumor histology<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Approximately 5 years | 
| Overall Response Rate (ORR) |  | Approximately 5 years | 
| Best Overall Response Rate (BORR) |  | Approximately 5 years | 
| Best Overall Response (BOR) |  | Approximately 5 years | 
| Duration of Response (DOR) |  | Approximately 5 years | 
| Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC |  | At baseline and for up to 5 years | 
| Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC |  | At baseline and for up to 5 years | 
| Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC |  | At baseline and for up to 5 years | 
| Distribution of Incidence of All Adverse Events (AEs) |  | Approximately 5 years | 
| Distribution of Severity of All Adverse Events (AEs) |  | Approximately 5 years | 
| Distribution of Management of All Adverse Events (AEs) |  | Approximately 5 years | 
| European Quality of Life-5 Dimensions (EQ-5D) |  | At baseline and for up to 5 years | 
| Lung Cancer Symptom Scale (LCSS) |  | At baseline and for up to 5 years |