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

NCT06868277 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small Cell Lung

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2030-01-17
Completion
2030-12-02
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868277 on ClinicalTrials.gov