Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
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
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC | At baseline and for up to 5 years |
| Distribution of socio-demographic characteristics 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 clinical characteristics in adult patients diagnosed with advanced NSCLC | At baseline and for up to 5 years |
| Distribution of Management of All Adverse Events (AEs) | 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 Severity of All Adverse Events (AEs) | Approximately 5 years |
| Progression-Free Survival (PFS) | Approximately 5 years |
Countries
Germany
Outcome results
None listed