The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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 first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,160
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 electronic Case Report Form (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 complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
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Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Research Site
Tucson, Arizona, United States
RECRUITINGResearch Site
Springdale, Arkansas, United States
RECRUITINGResearch Site
Anaheim, California, United States
RECRUITINGResearch Site
Beverly Hills, California, United States
RECRUITINGResearch Site
Loma Linda, California, United States
RECRUITINGResearch Site
Los Alamitos, California, United States
RECRUITINGResearch Site
Redlands, California, United States
RECRUITINGResearch Site
San Francisco, California, United States
RECRUITINGResearch Site
Walnut Creek, California, United States
RECRUITINGResearch Site
West Haven, Connecticut, United States
RECRUITING...and 318 more locations
Time frame: Up to approximately 6 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 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 6 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. 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)
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 6 years