A study to find out how well Rilvegostomig works and how safe it is compared to Pembrolizumab as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) with high PD-L1 levels
Descrizione riassuntiva dello studio
The study drug Rilvegostomig is intended to help the immune system kill cancer cells by blocking 2 proteins on immune cells: PD-L1 and another protein called TIGIT. Researchers believe that Rilvegostomig may work better than Pembrolizumab as a first-line treatment for adults with metastatic NSCLC with high PD-L1 levels. In this study, researchers want to find out how well Rilvegostomig works and how safe it is compared to Pembrolizumab. This is a randomized phase 3 double-blind study. Randomized means that a computer program randomly assigns the treatment each participant receives (either Rilvegostomig or Pembrolizumab) (like flipping a coin). Double-blind means that none of the participants, researchers, study doctors, or other study staff know which treatment each participant is receiving. Participants will continue to receive the study treatment unless their cancer worsens, they have significant medical problems, or they leave the study for another reason.
(BASEC)
Intervento studiato
Participants will receive treatment (either Rilvegostomig or Pembrolizumab) every 3 weeks from trained staff through a needle into the vein (intravenously) until their cancer worsens, they have significant medical problems, or they leave the study for another reason. To monitor the health of participants during the study, doctors will do the following: ► Blood and urine tests ► Physical examinations ► Monitoring of vital signs (heart rate, respiratory rate, blood pressure, and body temperature) ► CT and/or MRI scans ► Testing heart function using an electrocardiogram (ECG) and other tests ► Inquiring about participants' medications and any medical problems.
(BASEC)
Malattie studiate
Metastatic non-small cell lung cancer (NSCLC)
(BASEC)
Documented metastatic non-small cell lung cancer (NSCLC) stage IV with high PD-L1 levels, with no prospect of curative treatment. Minimum life expectancy of 12 weeks. (BASEC)
Criteri di esclusione
At the discretion of the investigator, any severe or uncontrolled systemic diseases. History of organ transplantation. Active or previously documented autoimmune or inflammatory diseases requiring chronic treatment with steroids or other immunosuppressive agents. (BASEC)
Luogo dello studio
Losanna
(BASEC)
Sponsor
AstraZeneca AB, Sweden Fortrea Switzerland AG, Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Hasna Bouchabb
+41 (0)79 556 84 37
hasna.bouchaab@clutterchuv.chCHUV | Centre hospitalier universitaire vaudois, rue du bugnon 46, 1011 Lausanne
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
28.08.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
TITLE PAGE A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients with PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04) (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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