Advanced Non-small Cell Lung Cancer
Conditions
Keywords
Advanced non-small cell lung cancer (aNSCLC), Epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), C-ros oncogene receptor tyrosine kinase (ROS1)
Brief summary
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.
Detailed description
Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.
Interventions
DRUGREGN2810
No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.
No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
1. Patients who have EGFR, ALK or ROS1 variants 2. Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date 3. Patients actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Real-world progression-free survival (rwPFS) | Approximately 3 years |
| IRR resulting in hospitalization | Approximately 3 years |
| Real-world overall survival (rwOS) | Approximately 3 years |
| IRR resulting in death | Approximately 3 years |
| Treatment-emergent immune-mediated adverse events (imAEs) | Approximately 3 years |
| Infusion-related reaction (IRR) | Approximately 3 years |
| Real-world duration of response (rwDOR) | Approximately 3 years |
Countries
United States
Outcome results
None listed