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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: REGN2810; Other: Platinum-doublet chemotherapy

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • Tarrytown, New York, United States, 10591
      • Regeneron Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Patients; 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.	Drug: REGN2810; No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.; Other Names: cemiplimab; LIBTAYO®; Other: Platinum-doublet chemotherapy; No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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
Treatment-emergent immune-mediated adverse events (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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 23, 2027

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Epidermal growth factor receptor (EGFR); Anaplastic lymphoma kinase (ALK); Advanced non-small cell lung cancer (aNSCLC); C-ros oncogene receptor tyrosine kinase (ROS1)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; cemiplimab
• Other Study ID Numbers: R2810-ONC-22115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No