NCT06627647 · AstraZeneca
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
What this study is about
The purpose of ARTEMIDE-Lung03 is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
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
DRUG
Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Primary outcome measures
Overall survival (OS)
Time frame: Up to approximately 6 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 6 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 non-squamous NSCLC.
- Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
- 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 therapies.
- Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
Where
- Mobile, Alabama
- Chandler, Arizona
- Phoenix, Arizona
- Anaheim, California
- Beverly Hills, California
- Loma Linda, California
- Redlands, California
- San Diego, California
- San Francisco, California
- Santa Rosa, California
- Walnut Creek, California
- Lone Tree, Colorado
And 62 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 Jul 14, 2026 · Source of record for eligibility and locations