Clinical trial NCT06269133: 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
Official title: Evaluating the Safety and Effectiveness of Cemiplimab in Combination With Platinum-Doublet Chemotherapy by Demographic Characteristics in First-Line Treatment of Advanced Non-Small Cell Lung Cancer: A Multi-Database Real World Evidence Study in US Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: Advanced non-small cell lung cancer (aNSCLC)
Epidermal growth factor receptor (EGFR)
Anaplastic lymphoma kinase (ALK)
C-ros oncogene receptor tyrosine kinase (ROS1)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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

Primary outcomes:
measure: Real-world response rate (rwRR)
timeFrame: Approximately 3 years
measure: Any treatment-emergent immune-mediated adverse event (imAE)
timeFrame: Approximately 3 years
measure: Any treatment-emergent imAE resulting in hospitalization
timeFrame: Approximately 3 years
measure: Any treatment-emergent imAE resulting in death
timeFrame: Approximately 3 years
measure: Specific treatment-emergent imAEs
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Real-world duration of response (rwDOR)
timeFrame: Approximately 3 years
measure: Real-world progression-free survival (rwPFS)
timeFrame: Approximately 3 years
measure: Real-world overall survival (rwOS)
timeFrame: Approximately 3 years
measure: Treatment-emergent immune-mediated adverse events (imAEs)
timeFrame: Approximately 3 years
measure: Infusion-related reaction (IRR)
timeFrame: Approximately 3 years
measure: IRR resulting in hospitalization
timeFrame: Approximately 3 years
measure: IRR resulting in death
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Regeneron Research Facility
state: New York
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: