A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
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)
- Carcinoma, Non-Small Cell Lung
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 830
- Started
- 10 April 2025
- Main results due
- 17 January 2030
- Study sites
- 304
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 of acceptable tumor sample for the central testing prior to randomization. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) 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 (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function Exclusion Criteria: * As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * History of organ transplant. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. * Active primary immunodeficiency/active infectious disease(s) * Active tuberculosis infection * Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer). * Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(304)
Research Site
La Mesa, California, United States
Not yet recruiting
Research Site
Los Alamitos, California, United States
Not yet recruiting
Research Site
Newark, Delaware, United States
Recruiting
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Bay Pines, Florida, United States
Recruiting
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Clearwater, Florida, United States
Recruiting
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Gainesville, Florida, United States
Recruiting
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St. Petersburg, Florida, United States
Recruiting
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Marietta, Georgia, United States
Recruiting
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Chicago, Illinois, United States
Recruiting
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Decatur, Illinois, United States
Recruiting
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Des Moines, Iowa, United States
Recruiting
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Waterloo, Iowa, United States
Not yet recruiting
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Leawood, Kansas, United States
Recruiting
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Lexington, Kentucky, United States
Not yet recruiting
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Owensboro, Kentucky, United States
Recruiting
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Bethesda, Maryland, United States
Recruiting
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Frederick, Maryland, United States
Recruiting
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Silver Spring, Maryland, United States
Recruiting
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Towson, Maryland, United States
Recruiting
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Saginaw, Michigan, United States
Not yet recruiting
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Bridgeton, Missouri, United States
Recruiting
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Lincoln, Nebraska, United States
Recruiting
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Reno, Nevada, United States
Recruiting
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Paramus, New Jersey, United States
Not yet recruiting
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Buffalo, New York, United States
Recruiting
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East Syracuse, New York, United States
Recruiting
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Fresh Meadows, New York, United States
Recruiting
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Rochester, New York, United States
Not yet recruiting
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Westbury, New York, United States
Recruiting
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Canton, Ohio, United States
Not yet recruiting
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Fountain Hill, Pennsylvania, United States
Recruiting
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Kittanning, Pennsylvania, United States
Not yet recruiting
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Philadelphia, Pennsylvania, United States
Recruiting
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Round Rock, Texas, United States
Not yet recruiting
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Aberdeen, Washington, United States
Recruiting
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Renton, Washington, United States
Not yet recruiting
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Charleston, West Virginia, United States
Recruiting
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Morgantown, West Virginia, United States
Recruiting
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Schofield, Wisconsin, United States
Not yet recruiting
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CABA, Argentina
Recruiting
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Córdoba, Argentina
Recruiting
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Pilar, Argentina
Recruiting
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Rosario, Argentina
Recruiting
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Rosario, Argentina
Recruiting
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Viedma, Argentina
Recruiting
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Hobart, Australia
Withdrawn
Research Site
Woolloongabba, Australia
Withdrawn
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Edegem, Belgium
Recruiting
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Jette, Belgium
Recruiting
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Libramont-Chevigny, Belgium
Recruiting
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Liège, Belgium
Recruiting
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Mechelen, Belgium
Recruiting
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Roeselaere, Belgium
Recruiting
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Blumenau, Brazil
Recruiting
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Fortaleza, Brazil
Recruiting
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Ijuí, Brazil
Recruiting
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Itajaí, Brazil
Recruiting
Research Site
Londrina, Brazil
Recruiting
Research Site
Passo Fundo, Brazil
Recruiting
Research Site
Porto Alegre, Brazil
Recruiting
Showing 60 of 304 sites — filter to narrow it down. 247 of the 304 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06868277. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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