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 first Line (1L) treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC participant subgroups defined by age, sex, race, and ethnicity. Participants will be retrospectively identified from at least two US Electronic Health Record (EHR)-based databases.
Detailed description
Participants 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; participants had previously been administered this treatment.
No study specific interventions for this non-interventional-observational study; participants 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. Participants who have EGFR, ALK or ROS1 variants 2. Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date 3. Participants 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 Duration Of Response (rwDOR) | Approximately 3 years |
| Real-world Progression-Free survival (rwPFS) | Approximately 3 years |
| Real-world Overall Survival (rwOS) | Approximately 3 years |
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed