A study of Pumitamig compared to Durvalumab after concurrent chemoradiotherapy in participants with unresectable stage III non-small cell lung cancer (NSCLC) (ROSETTA Lung-201)
Résumé de l'étude
A study of Pumitamig compared to Durvalumab after concurrent chemoradiotherapy in participants with unresectable stage III non-small cell lung cancer (NSCLC)
(BASEC)
Intervention étudiée
Experimental: Arm A:
Drug: Pumitamig
Specified dose on certain days
Other name: BMS-986545
Active comparator: Arm B:
Drug: Durvalumab
Specified dose on certain days
(BASEC)
Maladie en cours d'investigation
Non-small cell lung cancer (NSCLC)
(BASEC)
- Participants must have a histologically or cytologically confirmed diagnosis of unresectable stage III non-small cell lung cancer (NSCLC) - Participants must have received at least 2 cycles of platinum-based concurrent chemotherapy (a total radiation dose of at least 54 Gy). - Participants must not have disease progression (PD) after treatment with concurrent chemoradiotherapy (CCRT). - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. (BASEC)
Critères d'exclusion
- Participants with non-squamous histology must not have documented epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. - Participants must not have an active autoimmune disease. - Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary artery disease (within 6 months prior to randomization), ventricular arrhythmias, severe thrombotic or embolic events or severe hemorrhagic events within 6 months prior to randomization or significant risk of pulmonary hemorrhage. - Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or a history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ grade 2), or current or suspected ILD or pneumonitis. - Participants must not have received prior cancer therapy (other than CCRT) for locally advanced stage III disease. - Additional inclusion/exclusion criteria defined in the study protocol apply. (BASEC)
Lieu de l’étude
Bâle, Bellinzona, St-Gall, Autre
(BASEC)
Münsterlingen (Thurgau)
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Plaza 254 Blanchardstown Corporate Park 2 Ballycoolin Dublin 15 D15 T867 Ireland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Markus Jörger
41 (0)76 559 10 70
markus.joerger@clutterh-och.chHOCH Health Ostschweiz (Kantonsspital St. Gallen) Klinik für Medizinische Onkologie und Hämatologie Rorschacher Strasse 95 9007 St. Gallen
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
09.04.2026
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy (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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