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)
1. Overall survival (Time Frame - Up to 72 months): Date and primary cause of death
Secondary outcome:
1. Overall Response Rate (Time Frame - Up to 72 months): Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.
2. Time to Response (Time Frame - Up to 72 months): 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).
3. Time to Progression (Time Frame - Up to 72 months): Defined as the time from first dose of cemiplimab until the date of the first clinician-documented tumour progression.
4. Time to first subsequent anti-NSCLC treatment (Time Frame - Up to 72 months): Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment..
5. Duration of Response (Time Frame - Up to 72 months): 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.
6. Progression-Free Survival (Time Frame - Up to 72 months): 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.
7. Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice (Time Frame - Up to 72 months): Number of patients with serious and non-serious adverse events occurring during treatment
Cemiplimab (SAR439684- Libtayo): solution for injection via intravenous (IV) infusion
Quelle: ClinicalTrials.gov
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