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)

Non-small Cell Lung Cancer Clinical Trial

— CEMI-LUNG  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363319
• Other study ID #: R2810-ONC-2325
• Secondary ID: U1111-1275-9867
• Status: Recruiting
• Start date: October 27, 2022
• Est. completion date: October 27, 2028

Study information

• Verified date: September 2023
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023. The recruitment period will be 36 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 36 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Cemiplimab
solution for injection via intravenous (IV) infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Austria,  France,  Germany, 

Outcome

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