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Looking for participantsPhase3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

Sponsor: AstraZeneca

NCT ID: NCT06627647

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 (drug), Pembrolizumab (drug), Carboplatin (drug), Cisplatin (drug)
How long the study runs
Study runs about 72 months (dates as stated)
About the drug or intervention
Rilvegostomig — drug: Administered as one intravenously (IV) on Day 1 of each 21-day cycle · Pembrolizumab — drug: Administered as one intravenously (IV) on Day 1 of each 21-day cycle · Carboplatin — drug: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles · Cisplatin — drug: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles · Pemetrexed — drug: Administered as one 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
1,160
Started
2024-11-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-squamous non-small cell lung cancer
  • • Phase3 - 1,160 participants
  • • 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 locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-squamous non-small cell lung cancer

Where?

  • • Aberdeen - Research Site
  • • Cambridge - Research Site
  • • Edinburgh - Research Site
  • • Exeter - Research Site
  • • +6 more UK sites

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

About This Trial

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 locally advanced or metastatic non-squamous NSCLC 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, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).

Non-squamous Non-small Cell Lung Cancer

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:

  • ✓ short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements

What the study is looking for

  • ✓Histologically or cytologically documented non-squamous NSCLC.
  • ✓Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative...
  • ✓Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21...
  • ✓Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
  • ✓Adequate organ and bone marrow function

Who cannot take part

  • ✗Presence of small cell and neuroendocrine histology components.
  • ✗Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or...
  • ✗Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
  • ✗Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of...
  • ✗Active primary immunodeficiency/active infectious disease(s).
See the full criteria
Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage III B/C or IV NSCLC (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 and available 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. * Adequate organ and bone marrow function Exclusion Criteria: * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. * Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred \> 12 months after the end of systemic therapy treatment. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * 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. * Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Where Is This Study? (10 UK sites)

Research Site

Aberdeen AB25 2ZN, United Kingdom

Recruiting

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

Exeter EX2 5DW, United Kingdom

WITHDRAWN

Research Site

Greater London SW3 6JJ, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

London SE1 9RT, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Newcastle upon Tyne NE7 7AF, United Kingdom

Recruiting

Research Site

Torquay TQ2 7AA, 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