An Observational Study to Assess the Effectiveness and Safety of Cemiplimab in 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: Cemiplimab

Study type: Observational

Funder types: Industry

Identifiers

NCT05363319

U1111-1275-9867 (Registry Identifier)

R2810-ONC-2325

Details and patient eligibility

About

Primary Objective:

Describe the overall survival rate (OS) rate in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice.

Secondary Objectives:

• To describe the following in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice:

  • Objective response rate (ORR)
  • Time to response (TTR)
  • Time to progression
  • Time to first subsequent anti-NSCLC treatment (TTST)
  • Duration of response (DoR)
  • Progression-free Survival (PFS)

• Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

Full description

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

The recruitment period will be 36 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 36 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: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Treated with a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician (independent of the study) and in accordance with approved prescribing information, as follows:
• Initiating treatment within the eligibility period after the study launch and site initiation Or
• Has received one or two doses of cemiplimab within the eligibility period prior to the study launch and site initiation
• Can understand and complete the study-related questionnaires
• Must have given signed informed consent prior to any study activities

Exclusion criteria

• Has received more than two doses of cemiplimab prior to enrolment
• Has uncontrolled autoimmune disease
• Is receiving cemiplimab for an indication other than advanced NSCLC
• Has a contraindication to cemiplimab as noted in the local summary of product characteristics
• Presence of estimated glomerular filtration rate (EGFR), anaplastic lymphoma receptor (ALK), or c-ros oncogene 1 (ROS1) driver mutations
• Is concurrently participating in any other study of an investigational drug or procedure

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Trial design

300 participants in 1 patient group

Cohort 1

Description:

Patients who have initiated cemiplimab therapy for NSCLC under standard of care

Treatment:

Drug: Cemiplimab