A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
AstraZeneca
Summary
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 non-squamous mNSCLC whose tumors express PD-L1.
Description
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 non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage IV mNSCLC (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 targeted 1L…
Interventions
- DrugRilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
- DrugPembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
- DrugCarboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
- DrugCisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
- DrugPemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Locations (282)
- Research SiteMobile, Alabama
- Research SiteChandler, Arizona
- Research SitePhoenix, Arizona
- Research SiteAnaheim, California
- Research SiteBeverly Hills, California
- Research SiteLoma Linda, California