Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06868277

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Rilvegostomig (biological), Pembrolizumab (biological)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Rilvegostomig — biological: Administered intravenously (IV) on Day 1 of each 21-day cycle · Pembrolizumab — biological: Administered intravenously (IV) on Day 1 of each 21-day cycle
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
830
Started
2025-04-10
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small cell lung
  • • Phase3 - 830 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small cell lung

Where?

  • • Blackpool - Research Site
  • • Glasgow - Research Site
  • • Guildford - Research Site
  • • Hull - Research Site
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Carcinoma, Non-Small Cell Lung

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRALKROS1PD-L1

Treatment history

Treatments you must have had:

  • ✓ for all non-squamous histology subtypes

What the study is looking for

  • ✓Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
  • ✓Stage IV mNSCLC (that has spread non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8)...
  • ✓Minimum life expectancy of 12 weeks.
  • ✓Provision of acceptable tumor sample for the central testing prior to randomization.
  • ✓Adequate organ and bone marrow function

Who cannot take part

  • ✗As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the...
  • ✗History of organ transplant.
  • ✗Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other...
  • ✗Presence of small cell and neuroendocrine histology components.
  • ✗Brain metastases unless not causing symptoms, stable, and not requiring steroids or anticonvulsants for at least 4 weeks...
See the full 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.

Where Is This Study? (6 UK sites)

Research Site

Blackpool FY3 8NR, United Kingdom

Recruiting

Research Site

Glasgow G12 0YN, United Kingdom

Recruiting

Research Site

Guildford GU2 7XX, United Kingdom

Recruiting

Research Site

Hull HU16 5JQ, United Kingdom

Recruiting

Research Site

Northwood HA6 2RN, United Kingdom

Recruiting

Research Site

Oxford OX4 6LB, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09