Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients

Regeneron Pharmaceuticals

Status: Active, not recruiting

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: REGN2810; Other: Platinum-doublet chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06269133

R2810-ONC-22115

Details and patient eligibility

About

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.

Full description

Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/ Exclusion Criteria apply

Trial design

1,000 participants in 1 patient group

Study Patients

Description:

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.

Treatment:

Other: Platinum-doublet chemotherapy

Drug: REGN2810