Home › Trials › NCT05363319

Assessing the effectiveness and safety of cemiplimab in adults with advanced non-small cell lung cancer

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)

Observational Regeneron Pharmaceuticals · NCT05363319

This study is testing how well and safely cemiplimab works for adults with advanced non-small cell lung cancer while they receive regular care over several years.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionscemiplimab
Locations49 sites (Klagenfurt, Carinthia and 48 other locations)
Trial IDNCT05363319 on ClinicalTrials.gov

What this trial studies

This observational study focuses on adult patients diagnosed with advanced non-small cell lung cancer (NSCLC) who are prescribed cemiplimab as part of their routine clinical care. The study aims to gather data on the effectiveness and safety of cemiplimab treatment regimens over a period of up to 72 months. Participants will be monitored during regular clinical visits every three months while on treatment and every six months for up to 24 months after treatment discontinuation. The study will follow patients from the initiation of cemiplimab treatment until death, loss to follow-up, or study withdrawal.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically or cytologically documented squamous or non-squamous NSCLC who are prescribed cemiplimab as part of their standard care.

Not a fit: Patients who have previously received cemiplimab or have uncontrolled autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of cemiplimab for patients with advanced NSCLC.

How similar studies have performed: Other studies have shown promising results with cemiplimab in treating NSCLC, indicating that this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Klagenfurt, Carinthia and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.