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
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
AstraZeneca AB, Sweden Fortrea Switzerland AG, Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Hasna Bouchabb
+41 (0)79 556 84 37
hasna.bouchaab@clutterchuv.chCHUV | Centre hospitalier universitaire vaudois, rue du bugnon 46, 1011 Lausanne
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
28.08.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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