A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy

Study Overview
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Brief Summary
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The purpose of this trial is to describe the following, for each cohort, in real world conditions in France: The characteristics and treatment sequence of patients treated with nivolumab The effectiveness of nivolumab treatment The safety profile of nivolumab Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L

Official Title
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A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Pathologically confirmed diagnosis of advanced NSCLC Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label Previously treated with at least one prior chemotherapy- containing regimen Exclusion Criteria: Participants taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs Participants with a diagnosis of another primary cancer within the past five years Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study 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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Accepts Healthy Volunteers

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>Immuno-oncology (IO)-naïve patients | |
| Cohort 2<br>IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity | |
| Cohort 3<br>IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (TTF) |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Up to 3 years | 
| Progression-free survival (PFS) |  | Up to 3 years | 
| Time to next therapy (TTNT) |  | Up to 3 years | 
| Best overall response rate (BORR) |  | Up to 3 years | 
| Distribution of participant demographics characteristics: Age |  | Index date (treatment initiation date for each individual patient | 
| Distribution of participant demographics characteristics: Sex |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: Smoking status |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: Histology |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: TNM classification | TNM=Tumor Nodes Metastases | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: Location of metastases |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: EGFR mutation | EGRF=Epidural Growth Factor Receptor | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: ALK translocation | ALK= Anaplastic Lymphoma Kinase | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: HER2 mutation | HER2=Human Epidermal Growth Factor Receptor 2 | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: BRAF mutation |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: KRAS mutation |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: ROS1 mutation |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: MET mutation |  | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: PD-L1 expression | PD-L1=Programmed Death Ligand 1 | Index date (treatment initiation date for each individual patient) | 
| Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells | PD-L1=Programmed Death Ligand 1 | Index date (treatment initiation date for each individual patient) | 
| Incidence of Adverse Drug Reactions |  | 36 months after nivolumab treatment initiation | 
| Incidence of Seriousness criteria |  | 36 months after nivolumab treatment initiation | 
| Incidence of Intensity/ Grade |  | 36 months after nivolumab treatment initiation | 
| Incidence of AE duration |  | Follow-up period (Week 4 to Week 156) | 
| Incidence of Action taken regarding the BMS treatment |  | Follow-up period (Week 4 to Week 156) | 
| Incidence of Incidence rate |  | Follow-up period (Week 4 to Week 156) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer