Non-small Cell Lung Cancer Clinical Trial
— CEMI-LUNGOfficial title:
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)
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
Status | Recruiting |
Enrollment | 300 |
Est. completion date | October 27, 2028 |
Est. primary completion date | October 27, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Investigational Site Number: 040-001 | Klagenfurth Am Wörthersee | |
Austria | Investigational Site Number: 040-004 | Salzburg | |
France | Investigational Site Number: 250-003 | Angers | Maine-et-Loire |
France | Investigational Site Number: 250-009 | Avignon | Vaucluse |
France | Investigational Site Number: 250-005 | Clermont-Ferrand | Puy-de-Dôme |
France | Investigational Site Number: 250-008 | Le Mans | Sarthe |
France | Investigational Site Number: 250-004 | Marseille | Bouches-du-Rhône |
France | Investigational Site Number: 250-007 | Mulhouse | Haut-Rhin |
France | Investigational Site Number: 250-002 | Paris | |
France | Investigational Site Number: 250-006 | Poitiers | Vienne |
France | Investigational Site Number: 250-001 | Strasbourg | Bas-Rhin |
Germany | Investigational Site Number: 276-003 | Berlin | |
Germany | Investigational Site Number: 276-010 | Chemnitz | Sachsen |
Germany | Investigational Site Number: 276-015 | Dortmund | Nordrhein-Westfalen |
Germany | Investigational Site Number: 276-012 | Georgsmarienhütte | Niedersachsen |
Germany | Investigational Site Number: 276-016 | Halle | Sachsen-Anhalt |
Germany | Investigational Site Number: 276-005 | Konstanz | Baden-Württemberg |
Germany | Investigational Site Number: 276-001 | Leipzig | Sachsen |
Germany | Investigational Site Number: 276-019 | Mainz | Rheinland-Pfalz |
Germany | Investigational Site Number: 276-013 | München | Bayern |
Germany | Investigational Site Number: 276-006 | Nürnberg | Bayern |
Germany | Investigational Site Number: 276-009 | Troisdorf | Nordrhein-Westfalen |
Germany | Investigational Site Number: 276-002 | Weinsberg | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals |
Austria, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Date and primary cause of death | Up to 72 months | |
Secondary | Overall Response Rate | Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response. | Up to 72 months | |
Secondary | Time to Response | Defined as the time from the first cemiplimab dose until the date of first response observed for that patient. Patients who die during the study will be censored using the date of the last valid disease assessment). | Up to 72 months | |
Secondary | Time to Progression | Defined as the time from first dose of cemiplimab until the date of the first clinician-documented tumour progression. | Up to 72 months | |
Secondary | Time to first subsequent anti-NSCLC treatment | Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.. | Up to 72 months | |
Secondary | Duration of Response | Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause. | Up to 72 months | |
Secondary | Progression-Free Survival | Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause. | Up to 72 months | |
Secondary | Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice | Number of patients with serious and non-serious adverse events occurring during treatment | Up to 72 months |
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