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) (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

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Cemiplimab

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Austria
  • Klagenfurth Am Wörthersee, Austria, 9020
    • Recruiting
    • Investigational Site Number: 040-001
  • Salzburg, Austria, 5020
    • Recruiting
    • Investigational Site Number: 040-004
• France
  • Paris, France, 75970
    • Recruiting
    • Investigational Site Number: 250-002
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Recruiting
      • Investigational Site Number: 250-001
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13015
      • Recruiting
      • Investigational Site Number: 250-004
  • Haut-Rhin
    • Mulhouse, Haut-Rhin, France, 68100
      • Recruiting
      • Investigational Site Number: 250-007
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49933
      • Recruiting
      • Investigational Site Number: 250-003
  • Puy-de-Dôme
    • Clermont-Ferrand, Puy-de-Dôme, France, 63000
      • Recruiting
      • Investigational Site Number: 250-005
  • Sarthe
    • Le Mans, Sarthe, France, 72037
      • Recruiting
      • Investigational Site Number: 250-008
  • Vaucluse
    • Avignon, Vaucluse, France, 84000
      • Recruiting
      • Investigational Site Number: 250-009
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Recruiting
      • Investigational Site Number: 250-006
• Germany
  • Berlin, Germany, 14089
    • Recruiting
    • Investigational Site Number: 276-003
  • Baden-Württemberg
    • Konstanz, Baden-Württemberg, Germany, 78464
      • Recruiting
      • Investigational Site Number: 276-005
    • Weinsberg, Baden-Württemberg, Germany, 74189
      • Recruiting
      • Investigational Site Number: 276-002
  • Bayern
    • München, Bayern, Germany, 81925
      • Recruiting
      • Investigational Site Number: 276-013
    • Nürnberg, Bayern, Germany, 90419
      • Recruiting
      • Investigational Site Number: 276-006
  • Niedersachsen
    • Georgsmarienhütte, Niedersachsen, Germany, 49124
      • Recruiting
      • Investigational Site Number: 276-012
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44263
      • Recruiting
      • Investigational Site Number: 276-015
    • Troisdorf, Nordrhein-Westfalen, Germany, 53840
      • Recruiting
      • Investigational Site Number: 276-009
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Investigational Site Number: 276-019
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Recruiting
      • Investigational Site Number: 276-010
    • Leipzig, Sachsen, Germany, 04357
      • Recruiting
      • Investigational Site Number: 276-001
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 6120
      • Recruiting
      • Investigational Site Number: 276-016

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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. Ideally, patients will be enrolled in the study prior to their first infusion of cemiplimab; however, in keeping with the pragmatic nature of the study, patients who initiated cemiplimab treatment prior to site initiation may be enrolled in the study, provided they have not received more than two doses of cemiplimab prior to enrollment. The study will aim to enroll approximately 300 adult patients from up to 30 sites across Europe.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Patients who have initiated cemiplimab therapy for NSCLC under standard of care	Drug: Cemiplimab; solution for injection via intravenous (IV) infusion; Other Names: SAR439684- Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Date and primary cause of death	Up to 72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): October 27, 2028
• Study Completion (Estimated): October 27, 2028

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-2325; U1111-1275-9867 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org