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Clinical Trials in the UK / NCT06868277
Recruiting Phase 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

NCT06868277 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-04-10
Last updated
2026-08-03

Condition(s) studied

Carcinoma, Non-Small Cell Lung

Investigational drug(s) / intervention(s)

RilvegostomigPembrolizumab

Rilvegostomig: Administered intravenously (IV) on Day 1 of each 21-day cycle

Pembrolizumab: Administered intravenously (IV) on Day 1 of each 21-day cycle

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (304)

FacilityCityRegionStatus
Research Site La Mesa California Not Yet Recruiting
Research Site Los Alamitos California Not Yet Recruiting
Research Site Newark Delaware Recruiting
Research Site Bay Pines Florida Recruiting
Research Site Clearwater Florida Recruiting
Research Site Gainesville Florida Recruiting
Research Site St. Petersburg Florida Recruiting
Research Site Marietta Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Decatur Illinois Recruiting
Research Site Des Moines Iowa Recruiting
Research Site Waterloo Iowa Not Yet Recruiting
Research Site Leawood Kansas Recruiting
Research Site Lexington Kentucky Not Yet Recruiting
Research Site Owensboro Kentucky Recruiting
Research Site Bethesda Maryland Recruiting
Research Site Frederick Maryland Recruiting
Research Site Silver Spring Maryland Recruiting
Research Site Towson Maryland Recruiting
Research Site Saginaw Michigan Not Yet Recruiting
Research Site Bridgeton Missouri Recruiting
Research Site Lincoln Nebraska Recruiting
Research Site Reno Nevada Recruiting
Research Site Paramus New Jersey Not Yet Recruiting
Research Site Buffalo New York Recruiting
Research Site East Syracuse New York Recruiting
Research Site Fresh Meadows New York Recruiting
Research Site Rochester New York Not Yet Recruiting
Research Site Westbury New York Recruiting
Research Site Canton Ohio Not Yet Recruiting
Research Site Fountain Hill Pennsylvania Recruiting
Research Site Kittanning Pennsylvania Not Yet Recruiting
Research Site Philadelphia Pennsylvania Recruiting
Research Site Round Rock Texas Not Yet Recruiting
Research Site Aberdeen Washington Recruiting
Research Site Renton Washington Not Yet Recruiting
Research Site Charleston West Virginia Recruiting
Research Site Morgantown West Virginia Recruiting
Research Site Schofield Wisconsin Not Yet Recruiting
Research Site CABA Argentina Recruiting

+ 264 more sites — see the full list on the official registry below.

On this site

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More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868277 on ClinicalTrials.gov ↗ ← All trials in the UK