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

March 11, 2024 updated by: Regeneron Pharmaceuticals

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, and ROS1 genomic variants.

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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: Approximately 3 years
Approximately 3 years
Any treatment-emergent immune-mediated adverse event (imAE)
Time Frame: Approximately 3 years
Approximately 3 years
Any treatment-emergent imAE resulting in hospitalization
Time Frame: Approximately 3 years
Approximately 3 years
Any treatment-emergent imAE resulting in death
Time Frame: Approximately 3 years
Approximately 3 years
Specific treatment-emergent imAEs
Time Frame: Approximately 3 years
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Real-world duration of response (rwDOR)
Time Frame: Approximately 3 years
Approximately 3 years
Real-world progression-free survival (rwPFS)
Time Frame: Approximately 3 years
Approximately 3 years
Real-world overall survival (rwOS)
Time Frame: Approximately 3 years
Approximately 3 years
Treatment-emergent immune-mediated adverse events (imAEs)
Time Frame: Approximately 3 years
Approximately 3 years
Infusion-related reaction (IRR)
Time Frame: Approximately 3 years
Approximately 3 years
IRR resulting in hospitalization
Time Frame: Approximately 3 years
Approximately 3 years
IRR resulting in death
Time Frame: Approximately 3 years
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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