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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC patients with squamous tumor histology | |||
| NSCLC patients with non-squamous tumor histology |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Approximately 5 years | |
| Overall Response Rate (ORR) | Approximately 5 years | |
| Best Overall Response Rate (BORR) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Frankfurt | 60590 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |