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This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases.
Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Patients | Patients who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2810 | Drug | No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world response rate (rwRR) | Approximately 3 years | |
| Any treatment-emergent immune-mediated adverse event (imAE) | Approximately 3 years | |
| Any treatment-emergent imAE resulting in hospitalization | Approximately 3 years | |
| Any treatment-emergent imAE resulting in death | Approximately 3 years | |
| Specific treatment-emergent imAEs | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world duration of response (rwDOR) | Approximately 3 years | |
| Real-world progression-free survival (rwPFS) | Approximately 3 years | |
| Real-world overall survival (rwOS) |
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Key Inclusion Criteria:
1. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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Patients with advanced disease, defined as stage IIIB, IIIC, or IV disease, with evidence of administration of 1L cemiplimab in combination with platinum-doublet chemotherapy between 08 Nov 2022 and 30 Jun 2026 and without EGFR, ALK, or ROS1 genomic variants, or actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Facility | Tarrytown | New York | 10591 | United States |
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| Platinum-doublet chemotherapy | Other | No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment. |
|
| Approximately 3 years |
| Treatment-emergent immune-mediated adverse events (imAEs) | Approximately 3 years |
| Infusion-related reaction (IRR) | Approximately 3 years |
| IRR resulting in hospitalization | Approximately 3 years |
| IRR resulting in death | Approximately 3 years |
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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