A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDELung04)
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)
Sponsor: AstraZeneca
Listed as NCT06868277, this observational or N/A phase trial focuses on Carcinoma, Non-Small Cell Lung and remains actively recruiting participants. Sponsored by AstraZeneca, it has been updated 11 times since 2025, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
-
Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
-
Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
-
Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
-
Nov 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 6 earlier versions
-
Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
-
Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
-
Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
-
Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
-
Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Apr 2025 — Jun 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- AstraZeneca
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aberdeen, United States , Afula, Israel , Akashi, Japan , Alcabideche, Portugal , Amberg, Germany , Angers, France , Ankara, Turkey (Türkiye) , Athens, Greece , Athens, Greece , Athens, Greece and 284 more locations