Tests rilvegostomig against pembrolizumab as first treatment for advanced lung cancer
Compares rilvegostomig with pembrolizumab in adults with advanced lung cancer, PD-L1-high tumors.
Plain-language title generated from the registry record
Registry title: A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Key facts
- Where
- Hobart and Woolloongabba, AustraliaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV non-small cell lung cancer whose tumors have high PD-L1, who have not yet had treatment for advanced disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV (metastatic) non-small cell lung cancer, all cell subtypes, where treatment meant to remove all of the disease is not possible. Tumor must express PD-L1.
- Earlier treatment
- No earlier systemic treatment for advanced or metastatic disease. No earlier anti-PD-1, anti-PD-L1 or anti-TIGIT treatment.
- Biomarker or test result
- No sensitizing EGFR mutations, no ALK or ROS1 rearrangements, and no other changes with an approved first-line targeted treatment. A tumor sample must be provided for central testing.
Main reasons for not taking part
- History of organ transplant
- Autoimmune or inflammatory disease needing long-term steroids or other immune-suppressing treatment
- Small cell or neuroendocrine tumor parts
- Brain metastases, unless symptom-free and stable for at least 4 weeks without steroids or anticonvulsants
- Active tuberculosis or other active infection
Read by machine on 9 November 2026.
Where in Australia
- HobartHospital not named in the registryNo longer taking part
- WoolloongabbaHospital not named in the registryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06868277EU 2024-517780-24-00
- Record updated
- 25 September 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention; 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; 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 primary immunodeficiency/active infectious disease(s); Active tuberculosis infection; Presence of small cell and neuroendocrine histology components.