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

NCT06269133 | Active Not Recruiting FDA Drug

• 1 other identifier: R2810-ONC-22115
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (1)

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; Other: Platinum-doublet chemotherapy

Interventions

REGN2810 DRUG

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

Also known as: LIBTAYO®, cemiplimab

Study Patients

Platinum-doublet chemotherapy OTHER

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

Study Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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

You may not qualify if:

• Patients who have EGFR, ALK or ROS1 variants
• Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date
• Patients actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Research Facility

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

cemiplimab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 21, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 23, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)