A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
Summary
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
Detailed description
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.
Arms & interventions
- BiologicalRilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
- BiologicalPembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Outcome measures
Primary
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Up to approximately 5 years
Progression-Free Survival (PFS)
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
Time frame: Up to approximately 5 years
Secondary
Landmark Overall Survival (OS) rates
Time frame: Up to approximately 5 years
Landmark Progression-Free Survival (PFS) rates
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 5 years
Duration of Response (DoR)
Time frame: Up to approximately 5 years
Time to second progression or death (PFS2)
Time frame: Up to approximately 5 years
Pharmakokinetics (PK) of rilvegostomig
Time frame: Up to approximately 5 years
Immunogenicity of rilvegostomig
Time frame: Up to approximately 5 years
Patient-reported physical functioning
Time frame: Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL)
Time frame: Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time frame: Up to approximately 5 years
Eligibility criteria
Study locations (37)
Research Site
La Mesa, California, 91942
Research Site
Los Alamitos, California, 90720
Research Site
Farmington, Connecticut, 06030
Research Site
Newark, Delaware, 19713
Research Site
Bay Pines, Florida, 33744
Research Site
Clearwater, Florida, 33756
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St. Petersburg, Florida, 33705
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Marietta, Georgia, 30060
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Chicago, Illinois, 60612
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Decatur, Illinois, 62526
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Des Moines, Iowa, 50309
Research Site
Waterloo, Iowa, 50702
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Leawood, Kansas, 66209
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Lexington, Kentucky, 40536
Research Site
Owensboro, Kentucky, 42303
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Bethesda, Maryland, 20817
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Frederick, Maryland, 21702
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Silver Spring, Maryland, 20910
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Towson, Maryland, 21204
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Saginaw, Michigan, 48602
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Bridgeton, Missouri, 63044
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Lincoln, Nebraska, 68506
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Paramus, New Jersey, 07652
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Buffalo, New York, 14215
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East Syracuse, New York, 13057
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Fresh Meadows, New York, 11366
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Rochester, New York, 14642
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Westbury, New York, 11590
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Canton, Ohio, 44718
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Fountain Hill, Pennsylvania, 18015
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Kittanning, Pennsylvania, 16201
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Philadelphia, Pennsylvania, 19104
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Round Rock, Texas, 78665
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Aberdeen, Washington, 98520
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Renton, Washington, 98055
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Charleston, West Virginia, 25304
Research Site
Morgantown, West Virginia, 26506