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Taking people in BelgiumPhase 3

Tests rilvegostomig with chemotherapy for advanced squamous lung cancer

Tests rilvegostomig plus chemotherapy as first treatment in adults with advanced lung cancer.

Key facts

Who runs it
AstraZeneca
Where
Brussels, Charleroi, Kortrijk, and Ottignies-Louvain-la-Neuve, BelgiumSee the 4 sitesAlso in 25 other countries, 282 sites
Registry title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Status
Recruiting
Phase
Phase 3
People taking part
1,160 people, planned
Started
18 Nov 2024
Expected to end
1 Jul 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rilvegostomig
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab-paclitaxel
Record updated
29 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 squamous non-small cell lung cancer that has spread or is advanced, whose tumors show PD-L1, and who have not yet had treatment for it.

Age
18 years or older
Sex
All sexes
Disease stage
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.
Earlier treatment
No earlier systemic treatment for lung cancer that was not meant to remove all of the disease. No earlier anti-PD-1, anti-PD-L1 or anti-TIGIT treatment, and no other cancer treatment aimed at immune-regulating targets.
Biomarker or test result
Tumor PD-L1 expression of at least 1% (TC ≥ 1%). No known gene change in a treatable driver gene that has an approved first-line targeted therapy.

Main reasons for not taking part

  • Small cell or neuroendocrine parts in the tumor
  • Brain metastases, unless symptom-free, stable and off steroids or anticonvulsants for at least 7 days
  • Another cancer in the past, with some exceptions
  • Autoimmune or inflammatory disease needing long-term treatment that dampens the immune system
  • Active tuberculosis or other active infection, or active primary immunodeficiency

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Histologically or cytologically documented squamous NSCLC
  • Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment
  • Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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, non-curative therapy received for NSCLC
  • Any prior treatment with an anti-PD-1 or anti-PD-L1 agent
  • Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms
  • 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 or other 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 25 other countries, 282 sites

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

About the trial

What the trial wants to find out

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

The 2 groups in the trial

  • Arm ATreatment being tested

    Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig

    Treatment: Rilvegostomig, Carboplatin, Paclitaxel, and Nab-paclitaxel

  • Arm BExisting treatment, for comparison

    Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

    Treatment: Pembrolizumab, Carboplatin, Paclitaxel, and Nab-paclitaxel

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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
Plain-language title
Tests rilvegostomig with chemotherapy for advanced squamous 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 NCT06692738, who can take part
Record updated
29 October 2026