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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517780-24-00

Acronym

D702GC00001

Enrollment

383

Registered

2025-06-12

Start date

2025-09-18

Completion date

Unknown

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

Overall survival (OS), Progression-free survival (PFS)

Detailed description

Landmark overall survival (OS) rates, Landmark progression-free (PFS) rates, Overall response rate (ORR), Duration of response (DoR), Time to second progression or death (PFS2), Concentration of rilvegostomig in serum., Presence ADAs, titer, and neutralizing antibodies for rilvegostomig., Proportion of participants with maintained or improved physical functioning., Time to deterioration (TTD) of global health status (GHS)/quality of life (QoL) and in pulmonary symptoms., Adverse events (AEs) (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, physical examinations, and Eastern Cooperative Oncology Group (ECOG) performance status.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGINFLIXIMAB

DRUGMYCOPHENOLATE MOFETIL

DRUGRilvegostomig

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Landmark overall survival (OS) rates, Landmark progression-free (PFS) rates, Overall response rate (ORR), Duration of response (DoR), Time to second progression or death (PFS2), Concentration of rilvegostomig in serum., Presence ADAs, titer, and neutralizing antibodies for rilvegostomig., Proportion of participants with maintained or improved physical functioning., Time to deterioration (TTD) of global health status (GHS)/quality of life (QoL) and in pulmonary symptoms., Adverse events (AEs) (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, physical examinations, and Eastern Cooperative Oncology Group (ECOG) performance status.	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, France, Germany, Greece, Ireland, Italy, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026