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The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab + ipilimumab | Biological | First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant baseline socio-demographics | Baseline | |
| Participant baseline clinical characteristics | Baseline | |
| Participant treatment history | Baseline | |
| Treatment start and stop dates | Up to 6-months | |
| Reasons for 1L treatment selection | Day 1 | |
| Initial 1L NIC treatment dose received | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Day 1 |
| Type of chemotherapy received as part of NIC treatment | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Day 1 |
| Participant NIC treatment chemotherapy schedule | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Day 1 |
| Number of NIC treatment interruptions | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Up to 6-months |
| Date(s) of NIC treatment interruptions |
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Inclusion Criteria:
Exclusion Criteria:
• Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)
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The study population will include adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (NSCLC) and treated with 1L combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) in the US community oncology setting
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health | Dublin | Ohio | 43017 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy |
| Up to 6-months |
| Reasons for NIC treatment interruptions | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Up to 6-months |
| Length of NIC treatment delay/interruption | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Up to 6-months |
| Reasons for NIC treatment discontinuation | NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy | Up to 6-months |
| Type of 2L treatment received | Up to 6-months |
| Reasons for not initiating 2L treatment | Up to 6-months |
| Start and stop dates of 2L treatment initiation | Up to 6-months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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