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

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Cemiplimab; Drug: Platinum-based chemotherapy

• Registration Number: NCT05363319
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2022-10-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2028-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Cemiplimab	Cemiplimab monotherapy
Cohort 2	Cemiplimab	Cemiplimab in combination with platinum-based chemotherapy
Cohort 2	Platinum-based chemotherapy	Cemiplimab in combination with platinum-based chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 72 months	Date and primary cause of death

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	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.
Time to Response (TTR)	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).
Progression-Free Survival (PFS)	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.
Time to first subsequent anti-NSCLC treatment (TTST)	Up to 72 months	Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.
Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice	Up to 72 months	Number of patients with treatment related adverse events occurring during treatment
Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice	Up to 72 months	Number of patients with serious treatment related adverse events occurring during treatment
Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice	Up to 72 months	Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment
Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice	Up to 72 months	Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment
Overall Response Rate (ORR)	Up to 72 months	Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.

Trial Locations

Locations (23)

Investigational Site Number: 250-004; 🇫🇷 Marseille, Bouches-du-Rhône, France

Investigational Site Number: 276-012; 🇩🇪 Georgsmarienhütte, Niedersachsen, Germany

Investigational Site Number: 276-009; 🇩🇪 Troisdorf, Nordrhein-Westfalen, Germany

Investigational Site Number: 250-003; 🇫🇷 Angers, Maine-et-Loire, France

Investigational Site Number: 276-001; 🇩🇪 Leipzig, Sachsen, Germany

Investigational Site Number: 276-003; 🇩🇪 Berlin, Germany

Investigational Site Number: 276-013; 🇩🇪 München, Bayern, Germany

Investigational Site Number: 276-006; 🇩🇪 Nürnberg, Bayern, Germany

Investigational Site Number: 276-015; 🇩🇪 Dortmund, Nordrhein-Westfalen, Germany

Investigational Site Number: 276-019; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Investigational Site Number: 276-010; 🇩🇪 Chemnitz, Sachsen, Germany

Investigational Site Number: 040-001; 🇦🇹 Klagenfurt, Austria

Investigational Site Number: 040-004; 🇦🇹 Salzburg, Austria

Investigational Site Number: 250-001; 🇫🇷 Strasbourg, Bas-Rhin, France

Investigational Site Number: 250-008; 🇫🇷 Le Mans, Sarthe, France

Investigational Site Number: 250-002; 🇫🇷 Paris, France

Investigational Site Number: 276-002; 🇩🇪 Weinsberg, Baden-Württemberg, Germany

Investigational Site Number: 276-016; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Investigational Site Number: 250-007; 🇫🇷 Mulhouse, Haut-Rhin, France

Investigational Site Number: 250-005; 🇫🇷 Clermont-Ferrand, Puy-de-Dôme, France

Investigational Site Number: 250-006; 🇫🇷 Poitiers, Vienne, France

Investigational Site Number: 250-009; 🇫🇷 Avignon, Vaucluse, France

Investigational Site Number: 276-005; 🇩🇪 Konstanz, Baden-Württemberg, Germany