NCT06868277

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 830 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Detailed description

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Conditions

• Carcinoma, Non-Small Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	Rilvegostomig	Administered intravenously (IV) on Day 1 of each 21-day cycle
BIOLOGICAL	Pembrolizumab	Administered intravenously (IV) on Day 1 of each 21-day cycle

Timeline

• Start date: 2025-04-10
• Primary completion: 2030-01-17
• Completion: 2030-12-02
• First posted: 2025-03-10
• Last updated: 2026-03-02

Locations

288 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Malaysia, Portugal, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study