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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cemiplimab

    Drug

    solution for injection via intravenous (IV) infusion

  • Platinum-based chemotherapy

    Drug

    IV administration

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 22 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Date and primary cause of death

Time frame
Up to 72 months

Secondary outcomes

1

Overall Response Rate (ORR)

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

Time frame
Up to 72 months
2

Duration of Response (DoR)

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.

Time frame
Up to 72 months
3

Time to Response (TTR)

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).

Time frame
Up to 72 months
4

Progression-Free Survival (PFS)

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.

Time frame
Up to 72 months

Other outcomes

Sponsors and contacts

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