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A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

NCT06627647 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Interventions

DRUG

Pemetrexed

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

DRUG

Rilvegostomig

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

DRUG

Pembrolizumab

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

DRUG

Carboplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

DRUG

Cisplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

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
2024-11-27
Primary Completion
2029-05-10
Completion
2030-03-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Peru
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

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 NCT06627647 on ClinicalTrials.gov