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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
AstraZeneca
Summary
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 metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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 first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically documented squamous NSCLC. * Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted 1L therapies. * Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately…
Interventions
- DrugRilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
- DrugPembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
- DrugCarboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
- DrugPaclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
- DrugNab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Locations (301)
- Research SiteTucson, Arizona
- Research SiteSpringdale, Arkansas
- Research SiteAnaheim, California
- Research SiteBeverly Hills, California
- Research SiteLoma Linda, California
- Research SiteLos Alamitos, California