Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer
Brief summary
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
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure (TTF) | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Index date (treatment initiation date for each individual patient) | TNM=Tumor Nodes Metastases |
| Distribution of clinical characteristics: Location of metastases | Index date (treatment initiation date for each individual patient) | — |
| Distribution of clinical characteristics: EGFR mutation | Index date (treatment initiation date for each individual patient) | EGRF=Epidural Growth Factor Receptor |
| Distribution of clinical characteristics: ALK translocation | Index date (treatment initiation date for each individual patient) | ALK= Anaplastic Lymphoma Kinase |
| Overall survival (OS) | Up to 3 years | — |
| 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 | Index date (treatment initiation date for each individual patient) | PD-L1=Programmed Death Ligand 1 |
| Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells | Index date (treatment initiation date for each individual patient) | PD-L1=Programmed Death Ligand 1 |
| 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) | — |
| Distribution of clinical characteristics: HER2 mutation | Index date (treatment initiation date for each individual patient) | HER2=Human Epidermal Growth Factor Receptor 2 |
Countries
France
Outcome results
None listed