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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Facility

Tarrytown, New York, 10591, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Treatment and study plan

REGN2810

Drug

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

Other names: LIBTAYO®, cemiplimab

Platinum-doublet chemotherapy

Other

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

Primary outcomes

  1. Real-world response rate (rwRR)

    Time frame: Approximately 3 years

  2. Any treatment-emergent immune-mediated adverse event (imAE)

    Time frame: Approximately 3 years

  3. Any treatment-emergent imAE resulting in hospitalization

    Time frame: Approximately 3 years

  4. Any treatment-emergent imAE resulting in death

    Time frame: Approximately 3 years

  5. Specific treatment-emergent imAEs

    Time frame: Approximately 3 years

Secondary outcomes

  1. Real-world duration of response (rwDOR)

    Time frame: Approximately 3 years

  2. Real-world progression-free survival (rwPFS)

    Time frame: Approximately 3 years

  3. Real-world overall survival (rwOS)

    Time frame: Approximately 3 years

  4. Treatment-emergent immune-mediated adverse events (imAEs)

    Time frame: Approximately 3 years

  5. Infusion-related reaction (IRR)

    Time frame: Approximately 3 years

  6. IRR resulting in hospitalization

    Time frame: Approximately 3 years

  7. IRR resulting in death

    Time frame: Approximately 3 years

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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