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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
830
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered intravenously (IV) on Day 1 of each 21-day cycle
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
Landmark Overall Survival (OS) rates
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Up to approximately 5 years
Landmark Progression-Free Survival (PFS) rates
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
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.
Time frame: Up to approximately 5 years
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression).
Time frame: Up to approximately 5 years
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
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Research Site
La Mesa, California, United States
NOT_YET_RECRUITINGResearch Site
Los Alamitos, California, United States
NOT_YET_RECRUITINGResearch Site
Newark, Delaware, United States
RECRUITINGResearch Site
Bay Pines, Florida, United States
RECRUITINGResearch Site
Clearwater, Florida, United States
RECRUITINGResearch Site
Gainesville, Florida, United States
RECRUITINGResearch Site
St. Petersburg, Florida, United States
RECRUITINGResearch Site
Marietta, Georgia, United States
RECRUITINGResearch Site
Chicago, Illinois, United States
RECRUITINGResearch Site
Decatur, Illinois, United States
RECRUITING...and 294 more locations
Time frame: Up to approximately 5 years
Pharmakokinetics (PK) of rilvegostomig
Concentration of rilvegostomig in serum
Time frame: Up to approximately 5 years
Immunogenicity of rilvegostomig
Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Time frame: Up to approximately 5 years
Patient-reported physical functioning
Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.
Time frame: Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL)
Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration.
Time frame: Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration.
Time frame: Up to approximately 5 years