The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC 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, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,160
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
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 6 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 6 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 6 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 6 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 progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
Time frame: Up to approximately 6 years
Overall 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 6 years
Duration of response (DoR)
AstraZeneca Clinical Study Information Center
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Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Research Site
Mobile, Alabama, United States
RECRUITINGResearch Site
Chandler, Arizona, United States
WITHDRAWNResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Anaheim, California, United States
RECRUITINGResearch Site
Beverly Hills, California, United States
RECRUITINGResearch Site
Loma Linda, California, United States
RECRUITINGResearch Site
Redlands, California, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
San Francisco, California, United States
RECRUITINGResearch Site
Santa Rosa, California, United States
RECRUITING...and 290 more locations
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 6 years
Pharmacokinetic (PK) of rilvegostomig
Concentration of rilvegostomig in serum
Time frame: Up to approximately 6 years
Immunogenicity of rilvegostomig
Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig
Time frame: Up to approximately 6 years
Patient-reported physical functioning
Proportion of participants with maintained or improved physical functioning as measured by PROMIS PF-SF 8c - 7 day at each time point.
Time frame: Up to approximately 6 years
Patient-reported global health status (GHS)/quality of life (QoL)
TTD of GHS/QoL as measured by the EORTC IL172. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.
Time frame: Up to approximately 6 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
TTD in pulmonary symptoms as measured by the NSCLC-SAQ. TTD is defined as time from randomization to the date of first deterioration.
Time frame: Up to approximately 6 years