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 (CEMI-LUNG)

Regeneron Pharmaceuticals

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Platinum-based chemotherapy; Drug: Cemiplimab

Study type: Observational

Funder types: Industry

Identifiers

NCT05363319

U1111-1275-9867 (Registry Identifier)

R2810-ONC-2325

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. At least 18 years of age at the time of cemiplimab treatment initiation
2. Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
3. 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).
4. Can understand and complete the study-related questionnaires
5. 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:

1. Has received cemiplimab prior to enrollment
2. Has uncontrolled autoimmune disease
3. Has a contraindication to cemiplimab as noted in the local SmPC
4. Is concurrently participating in any other study of an investigational drug or procedure
5. 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

Trial design

500 participants in 2 patient groups

Cohort 1

Description:

Cemiplimab monotherapy

Treatment:

Drug: Cemiplimab

Cohort 2

Description:

Cemiplimab in combination with platinum-based chemotherapy

Treatment:

Drug: Cemiplimab

Drug: Platinum-based chemotherapy