NCT05363319 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
| NCT ID | NCT05363319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-10-26 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05363319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05363319 currently recruiting?
Yes, NCT05363319 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT05363319 trial being conducted?
This trial is being conducted at Klagenfurt, Austria, Salzburg, Austria, Mulhouse, France, Marseille, France and 11 additional locations.
Who is sponsoring the NCT05363319 clinical trial?
NCT05363319 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 500 participants.
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