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

Last updated: February 20, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

Cemiplimab

Platinum-based chemotherapy

Clinical Study ID

NCT05363319
R2810-ONC-2325
U1111-1275-9867
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 ornon-squamous NSCLC

  3. Prescribed a cemiplimab-based regimen as part of routine clinical practice asdetermined by the treating physician per standard of care and in accordance with theSummary 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 studyand have signed informed consent prior to any study activities

Exclusion

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 orprocedure

  5. Has cognitive impairment or other medical condition that, in the opinion of theinvestigator, would interfere with the ability to complete the study-relatedquestionnaires

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Cemiplimab
Phase:
Study Start date:
October 26, 2022
Estimated Completion Date:
October 30, 2028

Study 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.

Connect with a study center

  • Investigational Site Number: 1-11CBS6QG

    Grimmenstein, Niederösterreich 2840
    Austria

    Site Not Available

  • Investigational Site Number: 040-001

    Klagenfurt, 9020
    Austria

    Active - Recruiting

  • Investigational Site Number: 040-001

    Klagenfurth Am Wörthersee, 9020
    Austria

    Site Not Available

  • Investigational Site Number: 040-004

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Investigational Site Number: 250-001

    Strasbourg, Bas-Rhin 67000
    France

    Active - Recruiting

  • Investigational Site Number: 250-004

    Marseille, Bouches-du-Rhône 13015
    France

    Active - Recruiting

  • Investigational Site Number: 250-007

    Mulhouse, Haut-Rhin 68100
    France

    Active - Recruiting

  • Investigational Site Number: 250-003

    Angers, Maine-et-Loire 49933
    France

    Active - Recruiting

  • Investigational Site Number: 250-005

    Clermont-Ferrand, Puy-de-Dôme 63000
    France

    Active - Recruiting

  • Investigational Site Number: 1-YGJYO79

    Le Mans, Sarthe 72037
    France

    Active - Recruiting

  • Investigational Site Number: 250-008

    Le Mans, Sarthe 72037
    France

    Active - Recruiting

  • Investigational Site Number: 1-11FMS11M

    Avignon, Vaucluse 84000
    France

    Active - Recruiting

  • Investigational Site Number: 250-009

    Avignon, Vaucluse 84000
    France

    Active - Recruiting

  • Investigational Site Number: 1-11F4O2VV

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Investigational Site Number: 250-006

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Investigational Site Number: 250-002

    Paris, 75970
    France

    Active - Recruiting

  • Investigational Site Number: 276-005

    Konstanz, Baden-Württemberg 78464
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-002

    Weinsberg, Baden-Württemberg 74189
    Germany

    Site Not Available

  • Investigational Site Number: 276-013

    München, Bayern 81925
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-006

    Nürnberg, Bayern 90419
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-012

    Georgsmarienhütte, Niedersachsen 49124
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-015

    Dortmund, Nordrhein-Westfalen 44263
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-009

    Troisdorf, Nordrhein-Westfalen 53840
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-019

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Investigational Site Number: 276-010

    Chemnitz, Sachsen 09116
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-001

    Leipzig, Sachsen 04357
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-016

    Halle, Sachsen-Anhalt 6120
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-003

    Berlin, 14089
    Germany

    Active - Recruiting

  • Investigational Site Number: 724-008

    Malaga, Andalucia 29010
    Spain

    Active - Recruiting

  • Investigational Site Number: 724-001

    Jerez de la Frontera, Cadiz 11407
    Spain

    Active - Recruiting

  • Investigational Site Number: 724-002

    Lleida, 25198
    Spain

    Active - Recruiting

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