Observational Study for Lung Cancer Patients Treated With Nivolumab

Study Overview
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Brief Summary
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This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France

Official Title
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EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female: 18 age at the time of nivolumab initiation Pathologically confirmed diagnosis of lung cancer Patient initiating nivolumab :therapeutic decision to initiate nivolumab must be taken by the physician prior to enrolling a patient in the study Exclusion Criteria: -Patient taking part in an interventional study for lung cancer treatment for which nivolumab is 1 of the investigational drugs Other protocol defined inclusion or 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 |
| --- | --- |
| Lung Cancer patients in France<br>Lung Cancer patients treated by nivolumab in real life condition in France from October 2016 to October 2017 | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of gender |  | At baseline | 
| Distribution of age |  | At baseline | 
| Distribution of line of therapy at nivolumab initiation |  | At baseline | 
| Distribution of ECOG PS | Eastern Cooperative Oncology Group Performance Status (ECOG PS) A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis | At baseline | 
| Distribution of patients working status at nivolumab initiation |  | At baseline | 
| QoL (EQ-5D) at nivolumab initiation | Quality of Life (QoL) as assessed by European Quality of Life-5 Dimensions (EQ-5D) EQ-5D: the descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 3 levels (eg, no problems, moderate problems, extreme problems) | At baseline | 
| Median time from initial diagnosis to nivolumab initiation | Median time from initial diagnosis to nivolumab initiation (derived from date of initial diagnosis and date of first dose of nivolumab, assumed to be the date of D0 visit). Any lung cancer declaring more than 5 years after another cancer is defined as an initial diagnosis of lung cancer | At baseline | 
| Number of patients exposed to other lung cancer treatments |  | At baseline | 
| Distribution of current smokers, former smokers, and non-smokers at initial diagnosis |  | At baseline | 
| Distribution of cancer stage at initial diagnosis and at nivolumab initiation |  | At baseline | 
| Distribution of Lung cancer histology at initial diagnosis |  | At baseline | 
| Number of patients with untreated brain metastasis at nivolumab initiation |  | At baseline | 
| Number of patients with treated brain metastasis at nivolumab initiation |  | At baseline | 
| Number of patients with PD-L1 expression at nivolumab initiation | PD-LI (Programmed death-ligand 1) | At baseline | 
| Number of patients with mutations at nivolumab initiation |  | At baseline | 
| Distribution of concomitant diseases at nivolumab initiation |  | At baseline | 
| Number of patients with corticosteroids treatment at nivolumab initiation |  | At baseline | 
| (OS) Overall Survival | Time from index date (treatment with nivolumab) until date of death due to any cause | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival after initiation of nivolumab |  | Up to 2 years | 
| Distribution of nivolumab adverse drug reaction |  | At 3 years after nivolumab initiation | 
| Progression Free Survival (PFS) | PFS measured by time since index date (initial treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first as assessed by RECIST 1.1 | Up to 3 years after nivolumab initiation | 
| Objective Response Rate (ORR) | ORR is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors | Up to 3 years after nivolumab initiation | 
| Quality of Life (QoL) |  | Baseline to 3 years after nivolumab initiation | 
| Distribution of patient management treatment patterns |  | Baseline to 3 years | 
| Mean weight change in kilogram from baseline |  | Baseline up to 3 years | 
| Mean ECOG PS change from baseline |  | Baseline up to 3 years | 
| Distribution of patients with new metastasis |  | Up to 3 years | 
| Distribution of patients with progression of pre-existing sites |  | Up to 3 years |