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

Advanced Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06269133
• Other study ID #: R2810-ONC-22115
• Status: Active, not recruiting
• Start date: February 21, 2024
• Est. completion date: June 23, 2027

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 23, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• REGN2810
No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.

Other:
• Platinum-doublet chemotherapy
No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.

Locations

Country	Name	City	State
United States	Regeneron Research Facility	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world response rate (rwRR)		Approximately 3 years
Primary	Any treatment-emergent immune-mediated adverse event (imAE)		Approximately 3 years
Primary	Any treatment-emergent imAE resulting in hospitalization		Approximately 3 years
Primary	Any treatment-emergent imAE resulting in death		Approximately 3 years
Primary	Specific treatment-emergent imAEs		Approximately 3 years
Secondary	Real-world duration of response (rwDOR)		Approximately 3 years
Secondary	Real-world progression-free survival (rwPFS)		Approximately 3 years
Secondary	Real-world overall survival (rwOS)		Approximately 3 years
Secondary	Treatment-emergent immune-mediated adverse events (imAEs)		Approximately 3 years
Secondary	Infusion-related reaction (IRR)		Approximately 3 years
Secondary	IRR resulting in hospitalization		Approximately 3 years
Secondary	IRR resulting in death		Approximately 3 years