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.
Histologically or cytologically documented non-squamous NSCLC.
Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Parallel
Rilvegostomig
DrugAdministered as one intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab
DrugAdministered as one intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
DrugAdministered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Cisplatin
DrugAdministered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Pemetrexed
DrugAdministered as one 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.
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).
Landmark overall survival (OS) rates
OS is defined as the time from randomization until the date of death due to any cause.
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 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.
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.
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