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The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving first-line nivolumab plus ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + ipilimumab | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Up to 5 years | |
| Overall response rate (ORR) | Up to 5 years | |
| Best overall response (BOR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment
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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 | Naples | 80131 | Italy |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | 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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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Up to 5 years |
| Best overall response rate (BORR) | Up to 5 years |
| Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria | Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Time to response (TTR) | Up to 5 years |
| European Quality of Life-5 Dimensions (EQ-5D) Score | Baseline and up to 5 years |
| Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results | Baseline and up to 5 years |
| Treatment regimen | Up to 5 years |
| Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results | Baseline |
| Number of participants discontinuing treatment | Up to 5 years |
| Management of Adverse Events (AEs) | Up to 5 years |
| Participant socio-demographic characteristics | Baseline and up to 5 years |
| Participant clinical characteristics | Baseline and up to 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |