Clinical trial 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.

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.

Detailed description: Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.

The recruitment period will be 48 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 24 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.

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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 72 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 72 months
measure: Duration of Response (DoR)
timeFrame: Up to 72 months
measure: Time to Response (TTR)
timeFrame: Up to 72 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 72 months
measure: Time to first subsequent anti-NSCLC treatment (TTST)
timeFrame: Up to 72 months
measure: Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
timeFrame: Up to 72 months
measure: Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
timeFrame: Up to 72 months
measure: Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
timeFrame: Up to 72 months
measure: Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Investigational Site Number: 040-001
city: Salzburg
country: Austria
facility: Investigational Site Number: 040-004
city: Strasbourg
country: France
facility: Investigational Site Number: 250-001
state: Bas-Rhin
city: Marseille
country: France
facility: Investigational Site Number: 250-004
state: Bouches-du-Rhône
city: Mulhouse
country: France
facility: Investigational Site Number: 250-007
state: Haut-Rhin
city: Angers
country: France
facility: Investigational Site Number: 250-003
state: Maine-et-Loire
city: Clermont-Ferrand
country: France
facility: Investigational Site Number: 250-005
state: Puy-de-Dôme
city: Le Mans
country: France
facility: Investigational Site Number: 250-008
state: Sarthe
city: Avignon
country: France
facility: Investigational Site Number: 250-009
state: Vaucluse
city: Poitiers
country: France
facility: Investigational Site Number: 250-006
state: Vienne
city: Paris
country: France
facility: Investigational Site Number: 250-002
city: Konstanz
country: Germany
facility: Investigational Site Number: 276-005
state: Baden-Württemberg
city: Weinsberg
country: Germany
facility: Investigational Site Number: 276-002
state: Baden-Württemberg
city: München
country: Germany
facility: Investigational Site Number: 276-013
state: Bayern
city: Nürnberg
country: Germany
facility: Investigational Site Number: 276-006
state: Bayern
city: Georgsmarienhütte
country: Germany
facility: Investigational Site Number: 276-012
state: Niedersachsen
city: Dortmund
country: Germany
facility: Investigational Site Number: 276-015
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: Investigational Site Number: 276-009
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Investigational Site Number: 276-019
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Investigational Site Number: 276-016
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Investigational Site Number: 276-010
state: Sachsen
city: Leipzig
country: Germany
facility: Investigational Site Number: 276-001
state: Sachsen
city: Berlin
country: Germany
facility: Investigational Site Number: 276-003
city: Malaga
country: Spain
facility: Investigational Site Number: 724-008
state: Andalucia
city: Jerez de la Frontera
country: Spain
facility: Investigational Site Number: 724-001
state: Cadiz
city: Lleida
country: Spain
facility: Investigational Site Number: 724-002
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: