Clinical trial · Observational
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cemiplimab | Drug | Cemiplimab | ALIAS |
| Platinum-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Cemiplimab monotherapy
- interventionNames
- Drug: Cemiplimab
- label
- Cohort 2
- description
- Cemiplimab in combination with platinum-based chemotherapy
- interventionNames
- Drug: Cemiplimab
- Drug: Platinum-based chemotherapy
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Up to 72 months
- description
- Date and primary cause of death
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available