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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)

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ClinicalTrials.gov Identifier: NCT05363319
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : October 26, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief 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

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
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)
Actual Study Start Date : October 27, 2022
Estimated Primary Completion Date : October 27, 2028
Estimated Study Completion Date : October 27, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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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 Name: SAR439684- Libtayo


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 72 months ]
    Date and primary cause of death


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363319


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05363319    
Other Study ID Numbers: R2810-ONC-2325
U1111-1275-9867 ( Registry Identifier: ICTRP )
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: October 26, 2023
Last Verified: September 2023
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents