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NCT Number: NCT05363319

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.

The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt, Klagenfurt, Carinthia, Austria

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About this study

Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.

The recruitment period will be 48 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • At least 18 years of age at the time of cemiplimab treatment initiation
  • Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
  • Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).
  • Can understand and complete the study-related questionnaires
  • Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities

Key Exclusion Criteria:

  • Has received cemiplimab prior to enrollment
  • Has uncontrolled autoimmune disease
  • Has a contraindication to cemiplimab as noted in the local SmPC
  • Is concurrently participating in any other study of an investigational drug or procedure
  • Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

cemiplimab

Drug

solution for injection via intravenous (IV) infusion

Other names: SAR439684- Libtayo

Platinum-based Chemotherapy

Drug

IV administration

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 72 months

    Date and primary cause of death

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 72 months

    Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.

  2. Duration of Response (DoR)

    Time frame: Up to 72 months

    Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause.

  3. Time to Response (TTR)

    Time frame: Up to 72 months

    Defined as the time from the first cemiplimab dose until the date of first response observed for that patient. Patients who die during the study will be censored using the date of the last valid disease assessment).

  4. Progression-Free Survival (PFS)

    Time frame: Up to 72 months

    Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause.

  5. Time to first subsequent anti-NSCLC treatment (TTST)

    Time frame: Up to 72 months

    Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.

  6. Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Time frame: Up to 72 months

    Number of patients with treatment related adverse events occurring during treatment

  7. Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Time frame: Up to 72 months

    Number of patients with serious treatment related adverse events occurring during treatment

  8. Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Time frame: Up to 72 months

    Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment

  9. Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Time frame: Up to 72 months

    Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

Acronym: CEMI-LUNG

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 5, 2022
Registry last updated
Jul 24, 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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