NCT06868277 · AstraZeneca
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)
What this study is about
The purpose of ARTEMIDE-Lung04 is to assess the effectiveness and safety of rilvegostomig compared with pembrolizumab treatment given alone as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
View original scientific description
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.
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
Primary outcome measures
Overall Survival (OS)
Time frame: Up to approximately 5 years
OS is defined as the time from randomization until the date of death due to any cause.
Progression-Free Survival (PFS)
Time frame: Up to approximately 5 years
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
- Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.
- Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.
- WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
- Minimum life expectancy of 12 weeks.
- Provision o
Where
- La Mesa, California
- Los Alamitos, California
- Farmington, Connecticut
- Newark, Delaware
- Bay Pines, Florida
- Clearwater, Florida
- St. Petersburg, Florida
- Marietta, Georgia
- Chicago, Illinois
- Decatur, Illinois
- Des Moines, Iowa
- Waterloo, Iowa
And 25 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations