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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515008-38-00

Acronym

D702FC00001

Enrollment

241

Registered

2025-01-21

Start date

2025-02-14

Completion date

Unknown

Last updated

2026-01-20

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

Conditions

Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1

Brief summary

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

Detailed description

Landmark overall survival (OS) rates, Landmark progression-free survival (PFS) rates, Time to second progression or death (PFS2), Overall response rate (ORR), Duration of response (DoR), Concentration of rilvegostomig in serum., Presence of antidrug antibody (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, and Eastern Cooperative Oncology Group (ECOG) performance status.

Interventions

DRUGRilvegostomig

DRUGCARBOPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCISPLATIN

DRUGMYCOPHENOLATE MOFETIL

DRUGPEMETREXED

DRUGINFLIXIMAB

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 survival (PFS) rates, Time to second progression or death (PFS2), Overall response rate (ORR), Duration of response (DoR), Concentration of rilvegostomig in serum., Presence of antidrug antibody (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, and Eastern Cooperative Oncology Group (ECOG) performance status.	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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