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Taking people in BelgiumPhase 3

Tests rilvegostomig against pembrolizumab with chemotherapy for lung cancer

Tests rilvegostomig with chemotherapy in adults with non-squamous lung cancer.

Key facts

Who runs it
AstraZeneca
Where
Brussels, Charleroi, Kortrijk, Ottignies-Louvain-la-Neuve, and Sint-Niklaas, BelgiumSee the 5 sitesAlso in 24 other countries, 263 sites
Registry title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC
Status
Recruiting
Phase
Phase 3
People taking part
1,160 people, planned
Started
27 Nov 2024
Expected to end
18 Nov 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rilvegostomig
  • Pembrolizumab
  • Carboplatin
  • Cisplatin
  • Pemetrexed
Record updated
28 October 2026

Who can take part

AI summary

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 advanced or spread non-squamous non-small cell lung cancer whose tumors have PD-L1 and who have not yet had treatment for it.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-squamous non-small cell lung cancer, stage III B/C or IV, that cannot be treated with treatment meant to remove all of the disease. At least one measurable tumor that was not treated with radiation before.
Earlier treatment
No earlier medicine treatment for this lung cancer, except before or after surgery or chemoradiotherapy meant to remove all of the disease, if the cancer came back more than 12 months after it ended. No earlier anti-PD-1, anti-PD-L1 or anti-TIGIT treatment.
Biomarker or test result
Tumor PD-L1 expression TC ≥ 1%. No EGFR mutations of the sensitizing kind, no ALK or ROS1 changes, and no other gene changes that have an approved targeted first-line treatment.

Main reasons for not taking part

  • Small cell or neuroendocrine parts in the tumor
  • Brain metastases, unless symptom-free and stable
  • Another cancer in the past, unless treated and no active disease for 2 years or more
  • Autoimmune or inflammatory disease needing long-term treatment that dampens the immune system
  • Active tuberculosis or other active infection

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Presence of small cell and neuroendocrine histology components

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • What was the PD-L1 result of your tumour test?

Where in Belgium

Also in 24 other countries, 263 sites

  • CHIRECBrussels, BelgiumTaking people
  • Grand Hopital de CharleroiCharleroi, BelgiumTaking people
  • Algemeen Ziekenhuis GroeningeKortrijk, BelgiumTaking people
  • Clinique Saint PierreOttignies-Louvain-la-Neuve, BelgiumTaking people
  • VitazSint-Niklaas, BelgiumTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm ATreatment being tested

    Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

    Treatment: Rilvegostomig, Carboplatin, Cisplatin, and Pemetrexed

  • Arm BExisting treatment, for comparison

    Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

    Treatment: Pembrolizumab, Carboplatin, Cisplatin, and Pemetrexed

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
Plain-language title
Tests rilvegostomig against pembrolizumab with chemotherapy for lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06627647, who can take part
Record updated
28 October 2026